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Showing 20 of 27412 trials
Exercise Training in Women With Metastatic Breast Cancer
NCT07521826
Not yet recruiting
Conditions Cancer, Metastases
Phase NA
Enrollment 78
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

The primary objective of the study is to evaluate the effects of exercise on physical function, physical fitness, and body composition, with the main components including muscular strength, cardiorespiratory fitness, muscle mass, fat mass, and fat-free mass. The secondary objectives are to examine exercise adherence and the effects of exercise on health-related quality of life (HRQoL), cancer-related fatigue, and sleep quality. Additionally, the feasibility and safety of the exercise program will be assessed.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: Single

Interventions / Regimen

  • Other: Exercise — The multicomponent exercise intervention included a 10-minute warm-up consisting of balance, coordination, and stretching exercises. The main component was resistance training targeting the major muscle groups of the upper and lower body to improve strength and muscle mass. Six to eight exercises were performed using body weight, resistance bands, and dumbbells. Training progression was achieved by increasing load, repetitions, and/or sets, guided by the Borg 0-10 rating of perceived exertion scale, when health status allowed. The aerobic component consisted of walking, progressing to beginner-level running using short running intervals (50-100 m) interspersed with walking until longer continuous distances were achieved. Heart rate was monitored throughout the aerobic session.

Primary Outcomes

  • Cardiorespiratory endurance and functional capacity (Baseline and week 24 (post exercise intervention))
  • Lower-limb muscle strength (Baseline and week 24 (post exercise intervention))
  • Handgrip strength (Baseline and week 24 (post exercise intervention))
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-04
Completion: 2028-12
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 78 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: State University of Londrina
Contact Information
Study Contact:
Rafael Deminice, PhD
+5543991916013
rdeminice@uel.br
Interventions
  • Other: Exercise — The multicomponent exercise intervention included a 10-minute warm-up consisting of balance, coordination, and stretching exercises. The main component was resistance training targeting the major muscle groups of the upper and lower body to improve strength and muscle mass. Six to eight exercises were performed using body weight, resistance bands, and dumbbells. Training progression was achieved by increasing load, repetitions, and/or sets, guided by the Borg 0-10 rating of perceived exertion scale, when health status allowed. The aerobic component consisted of walking, progressing to beginner-level running using short running intervals (50-100 m) interspersed with walking until longer continuous distances were achieved. Heart rate was monitored throughout the aerobic session.
Study Locations (1 sites)
Universidade Estadual de Londrina, Londrina, Londrina, Paraná 86047-597 Brazil
Eligibility Criteria
Inclusion Criteria: * Women aged ≥ 18 years; * Confirmed diagnosis of stage IV (metastatic) breast cancer; * Currently undergoing medical treatment; * Willingness and functional independence to participate in the exercise program; * Medical clearance to engage in structured physical exercise. Exclusion Criteria: * Presence of unstable bone metastases. * Untreated or symptomatic brain metastases; * Evidence of severe cardiovascular disease identified by electrocardiogram (ECG); * Severe active infection; * Uncontrolled severe respiratory insufficiency or dependence on supplemental oxygen at rest or during exercise; * Uncontrolled severe pain; * Any other medical condition contraindicating participation in physical exercise; * Conditions that impair adherence to study procedures or the ability to provide informed consent; * Pregnancy.
Endoscopic Nipple-Sparing Mastectomy Through a Single Axillary Incision in Breast Cancer
NCT07507890
Recruiting
Conditions Breast Cancer - Ductal Carcinoma in Situ...
Phase NA
Enrollment 10
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

This single-center prospective study will evaluate the feasibility and safety of endoscopic nipple-sparing mastectomy (E-NSM) performed through a single axillary incision in selected women with breast cancer undergoing direct-to-implant breast reconstruction. The study will assess procedural feasibility, completeness of resection, short-term postoperative complications, and patient-reported outcomes

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Procedure: Endoscopic Nipple-Sparing Mastectomy (E-NSM) — Endoscopic nipple-sparing mastectomy performed through a single extra-mammary axillary incision using a standardized minimally invasive surgical technique; immediate direct-to-implant reconstruction will be performed according to institutional practice.

Primary Outcomes

  • Successful completion of endoscopic nipple-sparing mastectomy without conversion to open surgery (During the index surgical procedure)
  • Total operative time (During the index surgical procedure)
  • Negative surgical margin rate (From surgery to final pathology assessment, up to 30 days after surgery)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2025-06-11
Completion: 2026-12-30
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 10 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Fondazione del Piemonte per l'Oncologia
Contact Information
Study Contact:
Antonio Toesca, MD
0119933628
antonio.toesca@ircc.it
Giada Pozzi, MD
0119933676
giada.pozzi@ircc.it
Interventions
  • Procedure: Endoscopic Nipple-Sparing Mastectomy (E-NSM) — Endoscopic nipple-sparing mastectomy performed through a single extra-mammary axillary incision using a standardized minimally invasive surgical technique; immediate direct-to-implant reconstruction will be performed according to institutional practice.
Study Locations (1 sites)
Breast Unit, Candiolo, Turin 10060 Italy
Eligibility Criteria
Inclusion Criteria: * Female participants aged 18 years or older. * Diagnosis of early-stage invasive breast cancer or ductal carcinoma in situ, including multifocal or multicentric disease. * Candidate for nipple-sparing mastectomy with immediate direct-to-implant reconstruction. * Small- to medium-sized breasts with ptosis grade 2 or less. * Written informed consent provided. Exclusion Criteria: * Preoperative evidence of skin involvement, nipple-areola complex involvement, lymph-node metastases, inflammatory breast cancer, Paget's disease, mesenchymal breast tumors, or recurrent breast cancer. * Previous ipsilateral breast surgery. * Previous thoracic radiation therapy. * Heavy smoking (\>20 cigarettes/day), uncontrolled diabetes mellitus, or body mass index \>30. * ASA score 3 or higher. * Ongoing pregnancy
Wearable Ultrasound Patch for Breast Imaging
NCT07186491
Not yet recruiting
Conditions Breast Cancer, Breast Abnormalities, Bre...
Phase NA
Enrollment 50
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to learn if a wearable ultrasound (US) patch can provide reliable whole-breast imaging and accurately detect breast lesions in patients undergoing breast health evaluation. The main questions it aims to answer are: * How well does the US-patch detect breast lesions in breasts of different shapes, sizes, and tissue densities? * Are there any side effects or discomfort from using the US-patch? Researchers will compare results from the wearable US-patch to conventional ultrasound to see if the patch provides specific and sensitive findings. Participants will: * Have breast imaging performed with the wearable US-patch, which is applied directly to the breast and secured with a sports bra. * Use a guiding software application that helps correctly position the patch. * Complete the imaging session in less than 15 minutes, performed by study personnel.

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Diagnostic Masking/blinding: None

Interventions / Regimen

  • Device: Wearable Ultrasound Patch — The Wearable Ultrasound Patch is a non-invasive imaging device designed to provide real-time breast imaging (3D) through a flexible, skin-adherent US transducer array. The patch conforms to the natural shape of the breast and allows for continuous and comfortable imaging, reducing patient discomfort and improving diagnostic efficiency. It is intended for use as an adjunct imaging tool for breast health assessment, enabling early detection and follow up of lesions in diverse breast morphologies. Patients will use a newly developed software application named "myFUS" to properly position the US probe on their body. The software application will prompt patients through all the required steps to complete the screening. The first imaging session will be performed by the study personnel with the help of the myFUS application.

Primary Outcomes

  • Sensitivity and Specificity of the Wearable Ultrasound Patch for Detecting Breast Lesions (From enrollment to 1 week after initial imaging)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-09-01
Completion: 2027-03
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 50 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Massachusetts General Hospital
Collaborators: Massachusetts Institute of Technology
Principal Investigators:
  • Tolga Ozmen, M.D. (PRINCIPAL_INVESTIGATOR) - Massachusetts General Hospital
Contact Information
Study Contact:
Tolga Ozmen, M.D.
617-643-4398
tozmen@mgh.harvard.edu
Interventions
  • Device: Wearable Ultrasound Patch — The Wearable Ultrasound Patch is a non-invasive imaging device designed to provide real-time breast imaging (3D) through a flexible, skin-adherent US transducer array. The patch conforms to the natural shape of the breast and allows for continuous and comfortable imaging, reducing patient discomfort and improving diagnostic efficiency. It is intended for use as an adjunct imaging tool for breast health assessment, enabling early detection and follow up of lesions in diverse breast morphologies. Patients will use a newly developed software application named "myFUS" to properly position the US probe on their body. The software application will prompt patients through all the required steps to complete the screening. The first imaging session will be performed by the study personnel with the help of the myFUS application.
Study Locations (1 sites)
Massachusetts General Hospital, Boston, Massachusetts 02114 United States
Eligibility Criteria
Inclusion Criteria: * Investigators will exclusively enroll patients who have undergone conventional US imaging for their breasts within the past month or are scheduled to undergo it within the upcoming month. * Patients with a history of breast cancer or prior breast surgery can also be enrolled * Female gender * Ages between 18 and 85 years old * Being able to understand, communicate, give valid consent to the study, and be understood by researchers Exclusion Criteria: * Having significant health problems (such as chronic or acute cardiovascular diseases, skin diseases) physical and/or behavioral health disabilities limiting participants' ability to follow directions and complete research related activities. * Being pregnant * Not having intact, healthy breast skin (having open scars or wounds around the location of the breast)
Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study
NCT06162559
Recruiting
Conditions Breast Cancer
Phase PHASE1
Enrollment 30
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

This is a single-center, phase 1b study evaluating the safety and feasibility of a neoadjuvant treatment with tucatinib, trastuzumab and pertuzumab in stage II-IIIA HER2-positive breast cancer.

Design

Study type: Interventional Phases: Phase1 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Tucatinib — Tucatinib 300mg is taken orally twice daily
  • Drug: Trastuzumab — Trastuzumab 6mg/kg is administered intravenously on day 1 (loading dose 8mg/kg) or subcutaneously 600mg on day 1 of each cycle
  • Drug: Pertuzumab — Pertuzumab 420mg is administered intravenously on day 1 (loading dose 840mg) or subcutaneously 600mg/kg (loading dose 1200mg) on day 1 of each cycle

Primary Outcomes

  • Incidence and severity of adverse events (an average of 8 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2023-12-18
Completion: 2036-05
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: The Netherlands Cancer Institute
Collaborators: Seagen Inc.
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: Tucatinib — Tucatinib 300mg is taken orally twice daily
  • Drug: Trastuzumab — Trastuzumab 6mg/kg is administered intravenously on day 1 (loading dose 8mg/kg) or subcutaneously 600mg on day 1 of each cycle
  • Drug: Pertuzumab — Pertuzumab 420mg is administered intravenously on day 1 (loading dose 840mg) or subcutaneously 600mg/kg (loading dose 1200mg) on day 1 of each cycle
Study Locations (1 sites)
Netherlands Cancer Institute, Amsterdam, 1066CX Netherlands
Eligibility Criteria
Inclusion Criteria: 1. Signed written informed consent 2. Histologically confirmed primary invasive breast cancer 3. Stage II - IIIA primary breast cancer according to TNM-staging (8th edition, AJCC); (largest tumor diameter on DCE-MRI ≥ 2cm (cT2-3) and/or cN1-2 confirmed with FNA or histology) 4. HER2 overexpression defined as circumferential membrane staining that is complete, intense and in \>10% of invasive tumor cells (IHC 3+) on pre-treatment biopsy 5. Known estrogen- and progesterone-receptor expression of the invasive tumor a. ER-negative or PR-negative is defined as \<10% of invasive tumor cell nuclei are immunoreactive in the presence of evidence that the sample can express ER and/or PR 6. WHO performance status 0-1 7. Age ≥ 18 years 8. LVEF ≥50% measured by echocardiography or MUGA 9. Eligible for neoadjuvant treatment 10. Laboratory requirements within 21 days prior to enrollment: 1. Adequate bone marrow function (ANC ≥1.5 x 109/l, platelets ≥100 x 109/l); 2. Adequate hepatic function (ALAT, ASAT and bilirubin ≤2.5 times upper limit of normal). Subjects with Gilbert's syndrome may have a total bilirubin ≥2.5 × the ULN range, if no evidence of biliary obstruction exists. 3. Adequate renal function: creatinine clearance \>50 ml/min estimated using the Cockcroft-Gault equation or MDRD equation, or based on a 24-hour urine collection measurement. Exclusion Criteria: 1. Current pregnancy or breastfeeding 2. Current or previous other malignancy unless treated without systemic therapy and more than five years ago 3. Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule 4. Use of a strong CYP3A4 or CYP2C8 inhibitor within five half-lives of the inhibitor, or used a strong CYP3A4 or CYP2C8 inducer within five days prior to first dose of study treatment 5. Known chronic liver disease 6. History of inflammatory bowel disease or bowel resection 7. Contraindications for MRI 8. Inflammatory breast cancer, cT4 and/or cN3 tumors 9. Occult breast cancer (cT0)
Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
NCT06488378
Recruiting
Conditions Breast Cancer, PALB2-Mutated Breast Carc...
Phase PHASE1
Enrollment 20
Locations 2 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

This research is being done to evaluate the safety and tolerability of the new drug, axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer 1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative metastatic breast cancer. The names of the study drugs involved in this study are: * Axatilimab (a type of antibody) * Olaparib (a type of PARP inhibitor)

Design

Study type: Interventional Phases: Phase1 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Axatilimab — Humanized immunoglobulin G (IgG)4 monoclonal antibody, 1.3 mL sterile, preservative free glass vials, via intravenous (into the vein) infusion per protocol.
  • Drug: Olaparib — Inhibitor of poly ADP ribose polymerase (PARP)1-3, 100 or 150 mg tablet, taken orally per standard of care.

Primary Outcomes

  • Maximum Tolerated Dose (MTD) (Up to 4 weeks)
  • Recommended Phase 2 Dose (RP2D) (Up to 4 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2024-08-13
Completion: 2029-03-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Dana-Farber Cancer Institute
Collaborators: Incyte Corporation
Principal Investigators:
  • Filipa Lynce, MD (PRINCIPAL_INVESTIGATOR) - Dana-Farber Cancer Institute
Contact Information
Study Contact:
Filipa Lynce, MD
617-632-2335
filipa_lynce@dfci.harvard.edu
Interventions
  • Drug: Axatilimab — Humanized immunoglobulin G (IgG)4 monoclonal antibody, 1.3 mL sterile, preservative free glass vials, via intravenous (into the vein) infusion per protocol.
  • Drug: Olaparib — Inhibitor of poly ADP ribose polymerase (PARP)1-3, 100 or 150 mg tablet, taken orally per standard of care.
Study Locations (2 sites)
Dana-Farber Cancer Institute, Boston, Massachusetts 02215 United States
Mayo Clinic, Rochester, Minnesota 55902 United States
Eligibility Criteria
Inclusion Criteria: * Participants must have histologically or cytologically confirmed metastatic or unresectable HER2 negative breast cancer, including HER2 low (IHC 2+/ISH-, IHC 1+). Any ER and PR expressions are permitted but must be known. Patients with hormone receptor (HR) positive disease, defined by either ER and/or PR positivity, must have progressed or are intolerant to all available endocrine therapy regimens, or not candidates to further endocrine therapy-based approaches. * Documented germline or somatic mutation in BRCA1, BRCA2, or germline mutation in PALB2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function). Testing may be completed by any CLIA-certified laboratory. * Participants must have evaluable or measurable disease per RECIST 1.1 criteria. NOTE: If the only site of measurable of disease has been previously irradiated, there must be evidence of post-radiation progression. * Patients must have received no more than 2 prior lines of cytotoxic chemotherapy for metastatic disease. Antibody drug conjugates will count towards prior lines of cytotoxic chemotherapy, as well as checkpoint inhibitors. For the purposes of this study, prior treatment with hormonal therapy and non-hormonal targeted therapy, as well as the combination of an aromatase inhibitor and everolimus, are not counted as a prior cytotoxic therapy. * Age ≥18 years. * ECOG performance ≤ 2. * Participants must meet the following organ and marrow function as defined below: * leukocytes ≥ 3000/mcL * absolute neutrophil count ≥ 1.5 x 109/L * platelets ≥ 100 x 109/L * total bilirubin ≤ 1.5x institutional upper limit of normal (ULN) * AST(SGOT)/ALT(SGPT) ≤ 2.5x × institutional ULN or ≤5 × institutional ULN for participants with documented liver metastases * Creatinine clearance ≥ 51 mL/min (using Cockcroft-Gault equation) * Participants who are HBsAg positive are eligible if they have received HBV anti-viral therapy for at least 4 weeks and have undetectable HBV viral load prior to registration. * Note: Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. * Hepatitis B screening tests are not required unless: * Known history of HBV infection * As mandated by local health authority * Participants with a history of HCV infection are eligible if HCV viral load is undetectable at screening. * Note: Participants must have completed curative anti-viral therapy at least 4 weeks prior to registration. * Hepatitis C screening tests are not required unless: * Known history of HCV infection * As mandated by local health authority * HIV-infected participants must have well-controlled HIV on ART, defined as: * a. Participants on ART must have a CD4+ T-cell count ≥350 cells/mm3 at the time of screening. * b. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 or the LLOQ (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks before screening. * c. It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months. * d. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study. * e. The combination ART regimen must not contain any antiretroviral medications that interact with CYP3A4 inhibitors/inducers/substrates (https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and- drug-interactions-table-substrates-inhibitors-and-inducers) * Ability to swallow and retain oral study medication * Patients with a history of treated central nervous system (CNS) metastases are eligible, provided they meet all of the following criteria: * Disease outside the CNS is present * No clinical evidence of progression in the CNS since completion of CNS-directed therapy * Minimum of 2 weeks between completion of radiotherapy and Cycle 1 Day 1 * Recovery from significant (≥ Grade 3) acute toxicity with no requirement for escalating doses of corticosteroid over the 7 days prior to treatment start. * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. * Female participants must be postmenopausal or must have a negative serum pregnancy test performed during screening. Postmenopausal is defined as: * Amenorrhoeic for 1 year or more following cessation of exogenous hormonal treatments * Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50. * Radiation-induced oophorectomy with last menses \>1 year ago * Chemotherapy-induced menopause with \>1 year interval since last menses * Bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago * The effects of axatilimab and olaparib on the developing human fetus are unknown. For this reason, women of child-bearing potential and men who are sexually active with WOCBP must agree to use adequate contraception for the duration of study participation and for 4 months after discontinuation of treatment. * Participants must be willing to undergo 3 research biopsies: at baseline, after 2 weeks of olaparib monotherapy, and after 2 cycles of combination therapy. If biopsy is not feasible or safe, OR if the only area accessible to biopsy is also the only site of measurable disease per RECIST 1.1 criteria, permission must be obtained from the DFCI sponsor- investigator to forgo the mandatory research biopsies. Formal eligibility exception would not be required in these circumstances. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Clinical progression on a PARP inhibitor, or within 12 months of receipt of a PARP inhibitor, including but not limited to olaparib. * Any previous treatment with CSF1R antibody. * Patients who have had prior systemic chemotherapy, immune therapy, or investigational therapy within three weeks of initiation of protocol therapy. Endocrine therapy must have been discontinued at least 7 days prior to initiation of protocol therapy. Patients may receive bisphosphonates or denosumab during the study. * Participants who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 1) with the exception of alopecia, are excluded. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to axatilimab or olaparib. * Participants receiving any medications or substances that are strong or moderate inhibitors or inducers of CYP450 enzyme(s) are ineligible. This also includes strong or moderate CYP3A inhibitors and inducers. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. * Participants with a QTcF of \>470msec on screening ECG * Patients with a history of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML * Participants unable to swallow orally administered medication and participants with gastrointestinal disorders that are likely to interfere with absorption of the study medications in the opinion of the treating investigator (e.g. malabsorption syndrome or major stomach or bowel resections). * Uncontrolled intercurrent illness including, but not limited to, uncontrolled hypertension, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/socia
EQUITA - A Feasibility Trial of a Faith-placed Intervention to Increase Screening Uptake in Black Adults
NCT06981182
Not yet recruiting
Conditions Breast Cancer, Bowel Cancer, Cervical Ca...
Phase NA
Enrollment 300
Locations 3 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this randomised feasibility trial is to examine feasibility and acceptability of a co-produced and faith-placed intervention to increase uptake of breast, cervical, bowel, and abdominal aortic aneurysm (AAA) screening among Black communities in the North East of England, Leeds and Scotland, United Kingdom (UK). Participants will be invited to attend a two-hour workshop at each of the three study sites and will be randomly assigned to either the intervention group or the control group. This 24-month feasibility study will inform the development of a full-scale randomised-controlled trial co-produced for Black people that uses culturally appropriate messages that support screening for early diagnosis in this underserved group.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Other Masking/blinding: None

Interventions / Regimen

  • Other: Faith-placed intervention to promote breast, cervical, bowel, and AAA screening uptake in Black communities. — The intervention includes a two-hour workshop, delivered in person to the entire congregation, that aims to promote the uptake of breast, cervical, bowel, and AAA screening among Black communities in the North East of England, Leeds and Scotland. However, we will only include effectiveness data (i.e., surveys and screening uptake) from those who meet the study eligibility criteria. The intervention will be a peer-led, multidimensional community workshop. It will incorporate multiple components that tackle barriers to screening and that are present in the existing IMCAN and PROCAN-B interventions, if the PICE group believe these are helpful, such as health education about breast, cervical, bowel and AAA screening delivered by a healthcare provider with an opportunity to ask questions, personal testimonials through survivors' stories, as well as members of the community discussing experiences of screening, and utilising community and peer support and religious leaders.

Primary Outcomes

  • Narrative description of feasibility (Month 1 - 24)
  • (1) Number of churches recruited into the study (Month 3 - 7)
  • (2) Number of churches that consent to randomisation will be documented (Month 3 - 7)
  • (3) Number of participants recruited (Month 3 - 7)
  • (4) Distribution of recruited participants across age groups and screening programmes (Month 7 - 13)
  • (5) Proportion of participants retained at 3-month follow up (Month 10 - 15)
  • (6) Acceptability of the informed consent procedures to participants (Month 10 - 18)
  • (7) Suitability of data collection tools (Month 10 - 21)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2025-09-01
Completion: 2027-02-28
Eligibility
Age: 25 Years
Sex: ALL
Volunteers: true
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Sunderland
Collaborators: University of Glasgow
Contact Information
Study Contact:
Floor Christie-de Jong
0191 5153445
floor.christie@sunderland.ac.uk
Farhin Ahmed
0191 515 3000
Farhin.Ahmed@sunderland.ac.uk
Interventions
  • Other: Faith-placed intervention to promote breast, cervical, bowel, and AAA screening uptake in Black communities. — The intervention includes a two-hour workshop, delivered in person to the entire congregation, that aims to promote the uptake of breast, cervical, bowel, and AAA screening among Black communities in the North East of England, Leeds and Scotland. However, we will only include effectiveness data (i.e., surveys and screening uptake) from those who meet the study eligibility criteria. The intervention will be a peer-led, multidimensional community workshop. It will incorporate multiple components that tackle barriers to screening and that are present in the existing IMCAN and PROCAN-B interventions, if the PICE group believe these are helpful, such as health education about breast, cervical, bowel and AAA screening delivered by a healthcare provider with an opportunity to ask questions, personal testimonials through survivors' stories, as well as members of the community discussing experiences of screening, and utilising community and peer support and religious leaders.
Study Locations (3 sites)
University of Glasgow, Glasgow, Scotland G12 8QQ United Kingdom
Leeds Beckett University, Leeds, LS1 3HE United Kingdom
University of Sunderland, Sunderland, SR1 3SD United Kingdom
Eligibility Criteria
Inclusion Criteria: * Members of participating churches (North East of England, Leeds, Scotland) * Self-identify as Black, * Female aged 25-74, * Male aged 50-74, * Not up to date with all screening tests for which they are eligible, e.g., women who are up to date with one form of screening (e.g., breast) will be eligible for recruitment if they are not up to date with others (e.g., cervical or bowel). Exclusion Criteria: * Not a member of participating churches (North East of England, Leeds, Scotland). * Individuals who do not self-identify as Black * Do not self-identity as Black * Females aged outside the range of 25-74 * Males aged outside the range of 50-74. * Individuals who are up to date with all screening tests for which they are eligible.
Trial Evaluating Role of Post Mastectomy Radiotherapy in Women With Node Negative Early Breast Cancer
NCT02992574
Recruiting
Conditions Breastcancer
Phase NA
Enrollment 1022
Locations 7 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Postmastectomy radiotherapy (PMRT) is unequivocally beneficial in reducing the recurrences as well as improving survival in node positive breast cancer patients. PMRT for women with T1-T2 tumors and negative axillary nodes is not generally warranted because of the presumed low risk of recurrence in this population as a whole. However, in the setting of multiple adverse prognostic factors, the recurrence risk approaches and in some cases surpasses the risk of recurrence documented for patients with one to three positive lymph nodes. Numerous retrospective series have reported the outcome and patterns of failure for post-mastectomy patients treated without radiation. Many of these series have analyzed several high risk factors which were predictive of loco-regional recurrence wherein the role of adjuvant post-mastectomy radiation can be considered. Some authors have used combinations of prognostic factors, such as age, tumour size, grade, receptor status, Her2neu status and lympho-vascular space invasion to define subgroups with more specific risks of loco-regional recurrence than single factors alone. The current trial hypothesizes that "Post-mastectomy radiation in high risk, node negative early breast cancer patients decreases rates of loco-regional recurrence and improves disease free survival" and propose to address the question in randomized setting.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Radiation: Post Mastectomy Radiation therapy — Post mastectomy radiotherapy to the chest wall and ipsilateral supra-clavicular fossa to a dose of 40 Gy in 15 fractions over 3 weeks

Primary Outcomes

  • Disease free survival (5 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2016-05-27
Completion: 2033-12
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 1022 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Tata Memorial Centre
Principal Investigators:
  • Tabassum Wadasadawala, MBBS,MD,DNB (PRINCIPAL_INVESTIGATOR) - Assistant Professor, Radiation Oncology, Tata Memorial Centre
Contact Information
Study Contact:
Tabassum Wadasadawala, MBBS,MD,DNB
02227405078
twadasadawala@actrec.gov.in
Interventions
  • Radiation: Post Mastectomy Radiation therapy — Post mastectomy radiotherapy to the chest wall and ipsilateral supra-clavicular fossa to a dose of 40 Gy in 15 fractions over 3 weeks
Study Locations (7 sites)
Post Graduate Institute of Medical Education & Research, Chandigarh, Chandigarh 160012 India
Kolhapur Cancer Centre Pvt Ltd, Kolhāpur, Maharashtra 416234 India
Tata Memorial Centre, Mumbai, Maharashtra 400012 India
Max Super Speciality Hospital, Shalimar Bagh, Delhi, National Capital Territory of Delhi 110088 India
Max Super Speciality Hospital(A unit of Devki Devi Foundation), New Delhi, National Capital Territory of Delhi 110017 India
All India Institute of Medical Sciences, New Delhi, National Capital Territory of Delhi 110029 India
Bhagwan Mahaveer Cancer Hospital and Research Centre, Jaipur, Rajasthan 302017 India
Eligibility Criteria
Inclusion Criteria: * Women with unilateral pT1,2N0M0 breast cancer or multifocal breast cancer if largest discrete tumour at least 2cm or if the tumour area comprises multiple small adjacent foci of invasive carcinoma then overall maximum dimension taken. This must be greater than 2cm. * Upfront total mastectomy (with minimum 1 mm margin clear of invasive cancer or DCIS) and axillary staging procedure (clearance, sampling or SNB) * T2 tumors with one risk factor or T1 tumors with any of the following two high risk factors such as presence of high grade, lymphovascular invasion, ER/PR negative, HER2 positivity, age \< 35 years. * Fit to receive adjuvant radiation +/- chemotherapy (if indicated) +/- hormonal therapy (if indicated) * Written, informed consent Exclusion Criteria: * Any pTis/3/4, M1 patients * Patients who have any pathologically involved axillary nodes (micro-metastasis may be allowed) * Patients who have undergone neoadjuvant systemic therapy. * Previous or concurrent malignancy other than non melanomatous skin cancer and carcinoma in situ of the cervix * Pregnancy * Bilateral breast cancer * Not fit for surgery, radiotherapy or adjuvant systemic therapy * Unable or unwilling to give informed consent
PRehabilitation Intervention to Modify Eating for Breast Cancer Patients (PRIME)
NCT07638150
Not yet recruiting
Conditions Breast Cancer
Phase NA
Enrollment 20
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This single-arm pilot study evaluates the feasibility and acceptability of a 4-week Mediterranean diet-based feeding intervention as nutritional prehabilitation for newly diagnosed, treatment-naïve breast cancer patients prior to surgery. All meals are provided to participants. Secondary aims include assessing changes in body composition, metabolic biomarkers, inflammation, gut microbiome composition, patient-reported outcomes, and clinician-reported surgical recovery metrics.

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Other Masking/blinding: None

Interventions / Regimen

  • Other: Mediterranean Diet — A two-week cyclic menu (14 unique days of meals repeated) approach will be used for the Mediterranean diet intervention. Participants will be provided with 3 meals a day and receive daily snacks to consume.

Primary Outcomes

  • Feasibility of Enrollment (Up to 1 year)
  • Retention (8 weeks post-surgery)
  • Adherence (At 4 weeks.)
  • Acceptability (8 weeks post-surgery)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Not yet recruiting
Start Date: 2026-08
Completion: 2027-04
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Principal Investigators:
  • Tiffany Carson, PhD, MPH (PRINCIPAL_INVESTIGATOR) - Moffitt Cancer Center
Contact Information
Study Contact:
Alissa Pena
813-745-7710
Alissa.Pena@moffitt.org
Interventions
  • Other: Mediterranean Diet — A two-week cyclic menu (14 unique days of meals repeated) approach will be used for the Mediterranean diet intervention. Participants will be provided with 3 meals a day and receive daily snacks to consume.
Study Locations (1 sites)
Moffitt Cancer Center, Tampa, Florida 33612 United States
Eligibility Criteria
Inclusion Criteria: * Newly diagnosed stage I-III breast cancer. * Treatment-naïve; no neoadjuvant therapy planned. * Surgery scheduled at Moffitt in 1-2 months. * Post-menopausal. * BMI 28-35 kg/m². * NCI Fruit \& Vegetable Screener \<5 servings/day. * Willing to consume only study-provided meals. Exclusion Criteria: * Stage IV/metastatic disease. * Prior cancer. * Surgery scheduled sooner than 4-5 weeks. * NCI FVS ≥5 servings/day. * Celiac disease, severe food allergies, severe renal disease, uncontrolled diabetes, or medically prescribed incompatible diets.
Breast Cancer Molecular Subtypes and Skeletal Metastases Patterns on Bone Scintigraphy
NCT07750340
Not yet recruiting
Conditions Breast Cancer
Phase Not Applicable
Enrollment 100
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this observational study is to evaluate the association between different molecular subtypes of breast cancer and their specific patterns of skeletal metastases on Technetium-99m MDP bone scintigraphy. The study will include adult male and female patients aged 18 to 80 years with histopathologically confirmed breast cancer who are referred for whole-body bone scintigraphy. The main questions it aims to answer are: * What is the frequency and pattern of skeletal metastases across different breast cancer molecular subtypes (Luminal A, Luminal B, HER2-enriched, and Triple-Negative) on bone scintigraphy? * How do nuclear medicine scintigraphic findings correlate with tumor biomarker profiles? Researchers will compare imaging patterns among the different molecular subtype groups to determine if specific biomarker profiles correlate with distinct bone metastatic behaviors.

Design

Study type: Observational Observational model: Cohort Time perspective: Cross Sectional

Primary Outcomes

  • Presence of skeletal metastases on Tc-99m MDP whole-body bone scintigraphy. (Baseline)
  • Anatomical distribution of skeletal metastases. (Baseline)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2026-08
Completion: 2027-09
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sohag University
Principal Investigators:
  • Reham S Mohamed (PRINCIPAL_INVESTIGATOR) - Faculty of medicine sohag university
Contact Information
Study Contact:
Reham S Mohamed
+20 1064214014
Reham.Soltan@med.sohag.edu.eg
Interventions
N/A
Study Locations (1 sites)
Faculty of Medicine Sohag University, Sohag, Egypt
Eligibility Criteria
Inclusion Criteria: * Patients of both sexes (females and males) with a confirmed histopathological diagnosis of breast cancer, including all major histological types: Invasive Ductal Carcinoma (IDC), Invasive Lobular Carcinoma (ILC), other mixed or less common epithelial variants. * Patient's age ranging from 18 to 80 years. * Available immunohistochemical (IHC) profiles from the primary breast tumor biopsy or surgery, covering all molecular subtypes including; Luminal A: (ER-positive, PR-positive, HER2-negative, and low Ki-67 index). Luminal B: (ER-positive, PR-variable, HER2-variable "either positive or negative", and high Ki-67 index). HER2-enriched: (ER-negative, PR-negative, and HER2-positive). Triple-Negative breast cancer (TNBC): (no ER, PR or HER2 expression). * Patients referred for bone scintigraphy as part of initial staging, follow-up, or due to clinical suspicion of bone metastasis. Exclusion Criteria: * Patients with other primary malignancies (to avoid confusion regarding the origin of bone metastases). * Patients with incomplete medical records or unavailable immunohistochemical data. * Pregnant female patients. * Patients aged under 18 years old.
Platinum and Polyadenosine 5'Diphosphoribose Polymerisation Inhibitor for Neoadjuvant Treatment of Triple Negative Breast Cancer and/or Germline BRCA Positive Breast Cancer
NCT03150576
Recruiting
Conditions Breast Cancer
Phase PHASE2, PHASE3
Enrollment 780
Locations 30 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This neoadjuvant trial for patients with TNBC and/or gBRCA breast cancer, aims to investigate the safety and efficacy (improvement in pathological Complete Response at surgery) of concurrent platinum-based chemotherapy with olaparib an inhibitor of the PARP enzyme (PARPi).

Design

Study type: Interventional Phases: Phase2, Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Olaparib — Patients will self-administer Olaparib by mouth. Olaparib tablets should be taken twice daily at the same time each day approximately 12 hours apart.
  • Drug: Paclitaxel and Carboplatin — Paclitaxel I.V. 80mg/m2 in 0.9% sodium chloride 500ml or according to local practice, will be given over 60 minutes on days 1, 8 \& 15, every 3 weeks for 4 cycles. Carboplatin I.V. AUC5 in 5% dextrose 500ml or according to local practice, over 30-60minutes on day 1 every 3 weeks for 4 cycles.

Primary Outcomes

  • Stage 1 - Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.03. (1 year - when first 25 patients in each research arm who had received at least one dose of Olaparib protocol treatment have completed their protocol treatment.)
  • Stage 2 - pCR rate and completion rate of Olaparib treatment as per protocol. (15 months - when pathological complete response (pCR) is available for 53 patients in each of two research arms.)
  • Stage 3 - Efficacy analysis based on pCR at surgery. To be assessed by central review of pathology reports. (5.5 years - October 2021 approx.)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2, PHASE3
Status: Recruiting
Start Date: 2016-05
Completion: 2034-06
Eligibility
Age: 16 Years
Sex: ALL
Volunteers: false
Enrollment: 780 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust
Collaborators: AstraZeneca, Cancer Research UK
Principal Investigators:
  • Jean Abraham (PRINCIPAL_INVESTIGATOR) - The University of Cambridge, Department of Oncology
Contact Information
Study Contact:
CCTC A Cambridge Cancer Trials Centre
+44 (0)1223 348071
cuh.partner@nhs.net
Interventions
  • Drug: Olaparib — Patients will self-administer Olaparib by mouth. Olaparib tablets should be taken twice daily at the same time each day approximately 12 hours apart.
  • Drug: Paclitaxel and Carboplatin — Paclitaxel I.V. 80mg/m2 in 0.9% sodium chloride 500ml or according to local practice, will be given over 60 minutes on days 1, 8 \& 15, every 3 weeks for 4 cycles. Carboplatin I.V. AUC5 in 5% dextrose 500ml or according to local practice, over 30-60minutes on day 1 every 3 weeks for 4 cycles.
Study Locations (30 sites)
Cambridge University Hospitals NHS Foundation Trust & the University of Cambridge, Cambridge, Cambridgeshire CB2 0QQ United Kingdom
Queen's Hospital, Burton-on-Trent, Derby De13 ORB United Kingdom
The Christie, Manchester, Lancs M20 4GJ United Kingdom
Pinderfields General Hospital, Wakefield, Yorkshire WF1 4DG United Kingdom
University Hospital Ayr, Ayr, KA6 6DX United Kingdom
Basingstoke and North Hampshire Hospital, Basingstoke, RG24 9NA United Kingdom
Bedford General Hospital, Bedford, United Kingdom
Royal Bournemouth Hospital, Bournemouth, BH7 7DW United Kingdom
Bristol Haematology & Cancer Centre, Bristol, BS2 8ED United Kingdom
West Suffolk Hospital, Bury St Edmunds, IP33 2QZ United Kingdom
Eligibility Criteria
Inclusion Criteria: * Aged between 16 and 70. * Written informed consent, willing and able to comply with the Protocol for the duration of the trial including undergoing treatment and scheduled visits and examinations. * Histologically confirmed invasive breast cancer. * ER-negative\*, and HER2-negative\*\* breast cancer (TNBC). Patients will be eligible with any PR status but PR expression must be scored. OR * Germline BRCA (gBRCA) mutation positive, HER2 negative, and PgR / ER of any status. * T1, T2 or T3 tumours. * T4 tumour of any size with direct extension to (a) chest wall or (b) skin. OR Inflammatory carcinoma with tumour of any size. OR Other Locally Advanced Disease: * Involvement of ipsilateral large or fixed axillary lymph nodes, or infra or supraclavicular nodes (\>10mm diameter or clinical N2 or N3) and primary breast tumour of any diameter. * Involvement of ipsilateral large or fixed axillary lymph nodes, or infra or supraclavicular nodes (\>10mm diameter, or clinical N2 or N3), without a primary breast tumour identified, the presence of breast cancer in a Lymph Node (LN) must be histopathologically confirmed by LN biopsy. OR Multifocal tumour: \- with at least one tumour with a size\>10mm. * Patients with bilateral disease are eligible to enter the trial provided that both breast disease meets the above criteria. * Be fit to receive the trial chemotherapy regimen in the opinion of the responsible clinician: Adequate bone marrow, hepatic, and renal function. ECOG performance status of 0, or 1. * Treatment should be commenced within 6 weeks of the diagnostic biopsy. In uncommon circumstances, where medically acceptable, treatment is permitted to start within a maximum of 9 weeks of the diagnostic biopsy. * Availability of the Tumour Infiltrating Lymphocytes score is required. * Availability of CK 5/6 and EGFR +/- Androgen Receptor IHC score. * Availability of slides and paraffin embedded tissue blocks from pre-chemotherapy core biopsy and from primary surgical resection is required. * Women of child-bearing potential (WCBP), defined as not surgically sterilized or not post-menopausal for at least 24 consecutive months if age ≤55 year or 12 months if age \>55 years, must have a negative serum or urine pregnancy test within 14 days prior to randomisation. * All WCBP and all sexually active male patients as well as their partners must be aware that they should not conceive during the treatment period and therefore should routinely use effective forms of contraception, throughout their participation in the trial and for at least 6 months after the last dose of trial treatment. Please follow the olaparib contraception guidelines. Exclusion Criteria: * T0 tumour in absence of axillary node \>10mm. * TNBC with a non-basal phenotype which strongly expresses Androgen Receptor. * Previous or concomitant chemotherapy or biological agents used for the treatment of cancer in the last 5 years. * Malignancy within the last 5 years except: adequately treated non-melanoma skin cancer; curatively treated in situ cancer of the cervix; ductal carcinoma in situ (DCIS); Stage 1, grade 1 endometrial carcinoma; or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years. * Patients with myelodysplastic syndrome/acute myeloid leukaemia. * Evidence of distant metastasis apparent prior to randomisation. * Patients with uncontrolled seizures. * Pre-existing sensory or motor neuropathy of CTCAE v4.03, grade ≥2. * Concomitant use of known potent CYP3A4 inhibitors and inducers. Consider wash-out periods. * Pregnant or breast feeding women. * Not suitable for neoadjuvant chemotherapy in the opinion of the responsible clinician. * Major surgery within 14 days of starting trial treatment and patients must have recovered from any effects of any major surgery. * Any evidence of other disease or any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment or follow-up. For example: Evidence of severe or uncontrolled cardiac disease Uncontrolled ventricular arrhythmia Recent myocardial infarction (within 12 months) Active infection including Hepatitis B, Hepatitis C and Human Immunodeficiency virus (HIV). Screening for chronic conditions is not required. * ECG with mean resting QTc \>470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome. * Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the trial medication * Known hypersensitivity to olaparib, carboplatin, paclitaxel or their excipients (including cremophor). * Whole blood transfusions in the last 120 days prior to blood sampling for BRCA test as it may interfere with the results (packed red blood cells and platelet transfusions are acceptable).
A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors
NCT07361562
Recruiting
Conditions Advanced Solid Tumor, Adult, ERBB2 Alter...
Phase PHASE1
Enrollment 100
Locations 15 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This is an open-label, phase 1/1b study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4255 in adult participants with advanced solid tumors with ERBB2 alterations or HER2 overexpression.

Design

Study type: Interventional Phases: Phase1 Allocation: Non Randomized Intervention model: Sequential Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: CGT4255 — CGT4255 Daily Oral Administration

Primary Outcomes

  • Incidence and grade of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Part A] (Approximately 12 months)
  • Overall Response Rate [Part B and Part C] (Approximately 6 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2025-12-30
Completion: 2028-11
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Cogent Biosciences, Inc.
Contact Information
Study Contact:
Cogent Biosciences, Inc
617-945-5576
trialinfo@cogentbio.com
Interventions
  • Drug: CGT4255 — CGT4255 Daily Oral Administration
Study Locations (15 sites)
HonorHealth Research Institute, Scottsdale, Arizona 85258 United States
Mayo Scottsdale, Scottsdale, Arizona 85281 United States
Yale Cancer Center, New Haven, Connecticut 06510 United States
Mayo Jacksonville, Jacksonville, Florida 32209 United States
Northwestern University, Chicago, Illinois 60611 United States
LSU Health Sciences Center School of Medicine, New Orleans, Louisiana 70803 United States
START Midwest, Grand Rapids, Michigan 49546 United States
Mayo Rochester, Rochester, Minnesota 55905 United States
Washington University School of Medicine - Siteman Cancer Center, St Louis, Missouri 63110 United States
START NY Long Island, Lake Success, New York 11042 United States
Eligibility Criteria
Inclusion Criteria: 1. Have histologically confirmed diagnosis of: 1. Part A: Locally advanced, metastatic, and/or unresectable solid tumor with documented ERBB2-activating alteration or NRG1 gene fusion in blood and/or tumor or HER2 overexpression in tumor 2. Part B: Locally advanced, metastatic, and/or unresectable NSCLC with documented ERBB2 mutation in blood and/or tumor 3. Part C: Locally advanced, metastatic and/or unresectable breast cancer with documented ERBB2 mutation in blood and/or tumor or HER overexpression in tumor 2. Have measurable disease per RECIST v1.1. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1 for Part A. For Parts B and C, ECOG Performance Status must be 0 to 2. 4. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits. Exclusion Criteria: 1. Received small molecule chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug. 2. Major surgeries (eg, craniotomy and thoracotomy) within 4 weeks of the first dose of study drug. 3. Treatment with palliative focal radiotherapy (cranial or extracranial) (eg, stereotactic radiosurgery or intensity-modulated radiation therapy) ≤2 weeks before the first dose of study drug; treatment with whole-brain radiotherapy ≤4 weeks before the first dose of study drug. 4. Clinically significant cardiac disease. 5. Resolution of toxicities from prior therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities, before the first dose of study drug. 6. Restrictions on use of corticosteroid use to manage neurologic symptoms in different parts of the study.
ELVN-002 in HER2 Mutant Non-Small Cell Lung Cancer
NCT05650879
Active, positions filled
Conditions HER2 Mutant Non-small Cell Lung Cancer, ...
Phase PHASE1
Enrollment 198
Locations 39 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this clinical trial is to test ELVN-002 in people with cancers that have an abnormal HER2 gene. The main question the trial aims to answer is if ELVN-002 is safe and tolerable at different doses. A second main question is to evaluate the concentration of ELVN-002 in the blood at different doses and to see how this correlates with safety and see how the concentration of drug changes over time. The third main question is to see if ELVN-002 works to shrink cancers that have HER2 genetic abnormalities, particularly non-small cell lung cancer.

Design

Study type: Interventional Phases: Phase1 Allocation: Non Randomized Intervention model: Sequential Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: ELVN-002 — capsule
  • Drug: Fam-Trastuzumab Deruxtecan-Nxki — intravenous
  • Drug: Trastuzumab emtansine — intravenous

Primary Outcomes

  • Incidence of dose limiting toxicities in Phase 1a monotherapy (21 days)
  • Incidence of adverse events in Phase 1a monotherapy (24 months)
  • incidence of laboratory abnormalities in Phase 1a monotherapy (24 months)
  • incidence of ECG abnormalities in Phase 1a monotherapy (24 months)
  • incidence of dose limiting toxicities in Phase 1a combination with fam-trastuzumab deruxtecan (T-DXd) (42 days)
  • Incidence of adverse events in Phase 1a combination with T-DXd (24 months)
  • incidence of laboratory abnormalities in Phase 1a combination with T-DXd (24 months)
  • incidence of ECG abnormalities in Phase 1a combination with T-DXd (24 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Active, positions filled
Start Date: 2023-03-20
Completion: 2026-07
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 198 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Enliven Therapeutics
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Drug: ELVN-002 — capsule
  • Drug: Fam-Trastuzumab Deruxtecan-Nxki — intravenous
  • Drug: Trastuzumab emtansine — intravenous
Study Locations (39 sites)
University of Colorado - Anschutz Medical Campus - PPDS, Aurora, Colorado 80045 United States
Advent Health Orlando, Orlando, Florida 32804 United States
BRCR Medical Center Inc, Plantation, Florida 33322 United States
Dana Farber Cancer Institute, Boston, Massachusetts 02215 United States
NEXT/Virginia Cancer Specialists, Fairfax, Virginia 22031 United States
Macquarie University Hospital, Westmead, New South Wales 2145 Australia
Linear Clinical Research Limited, Nedlands, Western Australia 6009 Australia
Blacktown Hospital, Darlinghurst, 2010 Australia
Hôpital de la Timone Centre d'essais en cancérologie de Marseille (CEPCM-CLIPP), Marseille, Bouches-du-Rhône 13005 France
Hôpital Pontchaillou, Rennes, Brittany Region 35033 France
Eligibility Criteria
Inclusion Criteria: Phase 1a Monotherapy Dose Escalation and Exploration: * Pathologically documented advanced stage solid tumor * Progressed following all standard treatment or not appropriate for standard treatment * HER2 mutation, HER2 amplification or HER2 positive based on local testing Phase 1b Monotherapy * Pathologically documented unresectable and/or metastatic non-squamous NSCLC * HER2 mutation identified by tissue (fresh or archival) or ctDNA. Local testing for up to 20 patients the remainder centrally confirmed. * Measurable disease * No known epidermal growth factor receptor (EGFR), ROS1, anaplastic lymphoma kinase (ALK), or BRAF V600E mutation * Progressed after receiving at least 1 prior systemic therapy including a platinum-based chemotherapy with or without immunotherapy, or not appropriate for standard treatment. * No prior HER2 tyrosine kinase inhibitor. Prior HER2 directed antibodies or anti-body drug conjugates are allowed * No limit on prior number of therapies Phase 1a Combination with T-DXd * Pathologically documented advanced stage NSCLC * Progressed after receiving at least 1 prior systemic therapy. * HER2 mutation based on local/historical testing of tissue or circulating tumor DNA * No known EGFR, ROS1, ALK, or BRAF V600E mutation * No prior T-DXd * No clinically severe pulmonary compromise * No limit on prior number of therapies Phase 1a Combination Breast Cancer * Documented HER2 positive (Immunohistochemical \[IHC\] 3+ or IHC2+/in situ hybridization (ISH+) breast cancer * Must have previously received trastuzumab, a taxane, and T-DXd (if available and appropriate) in the metastatic setting. * No limit on prior number of therapies * No prior T-DM1 All Phases * Eastern Cooperative Oncology Group performance status of 0-1 * Left ventricular ejection fraction ≥ 50% * Platelet count ≥ 100 x 109/L * Hemoglobin ≥ 8.5 g/dL * Absolute neutrophil count ≥1.0 x 109/L * Total bilirubin \< 1.5 times upper limit of normal range (ULN), except for patients with Gilbert's syndrome * Aspartate aminotransferase (AST), alanine aminotransferase (ALT) \< 3 times ULN. In the setting of liver metastases \< 5 times ULN. * Creatinine clearance ≥ 60 mL/minute Exclusion Criteria All Phases: * Severe cardiac arrhythmias, requiring treatment, symptomatic congestive heart failure, myocardial infarction within 28 days prior to first dose, or unstable angina. * Another active malignancy within 2 years except basal cell skin cancer and carcinoma in situ treated curatively * Active or chronic liver disease * Active infection requiring systemic therapy within 14 days before the first dose * Brain lesion requiring immediate local therapy * Leptomeningeal disease * Uncontrolled seizures * Corrected QT interval (QTc) of \>470 milliseconds (ms) females or \>450 ms for males by Fridericia (QTcF)
Individuals on Hormone Therapy Breast Cancer Screening Pilot
NCT06383026
Recruiting
Conditions Breast Cancer
Phase Not Applicable
Enrollment 130
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This investigation is a prospective breast cancer screening study open to all individuals on hormone therapy. Using a mixed methods approach, the study will 1) gather prospective quantitative breast imaging data in conjunction with hormone therapy and family cancer history and 2) investigate individuals on hormone therapy perceptions and experiences in the breast cancer screening program, and 3) identify individual and systems-level barriers to breast cancer screening.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Diagnostic Test: Breast Cancer Screening — Screening mammography as well as whole breast ultrasound interpreted by BI-RADS.
  • Other: Survey/Interview — A mixed-methods approach including electronic surveys and one on one interviews.
  • Other: Focus Group — A semi-structured focus group with open-ended questions that explores faculty and staff experiences in a breast cancer screening program for individuals on hormone therapy.

Primary Outcomes

  • Callback and Biopsy Rates after Breast Cancer Screening (3.5 years)
  • Reflexive Thematic Analysis of the Physical, Cognitive, and Emotional Experience of Breast Cancer Screening in Individuals on Hormone Therapy (3.5 years)
  • Reflexive Thematic Analysis on the Individual & System-Level Barriers to Breast Cancer Screening (3.5 years)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-04-17
Completion: 2028-02
Eligibility
Age: 30 Years
Sex: ALL
Volunteers: true
Enrollment: 130 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Medical College of Wisconsin
Principal Investigators:
  • Chandler S Cortina, MD, MS (PRINCIPAL_INVESTIGATOR) - The Medical College of Wisconsin
Contact Information
Study Contact:
Chandler S Cortina, MD, MS
4149551453
ccortina@mcw.edu
Interventions
  • Diagnostic Test: Breast Cancer Screening — Screening mammography as well as whole breast ultrasound interpreted by BI-RADS.
  • Other: Survey/Interview — A mixed-methods approach including electronic surveys and one on one interviews.
  • Other: Focus Group — A semi-structured focus group with open-ended questions that explores faculty and staff experiences in a breast cancer screening program for individuals on hormone therapy.
Study Locations (1 sites)
Medical College of Wisconsin, Milwaukee, Wisconsin 53226 United States
Eligibility Criteria
Inclusion Criteria for Individuals on Hormone Therapy: 1. Males 40-75 years of age with a history of ≥9 months of estrogen and/or progesterone hormone therapy. 2. Females 40-75 years of age with any history of testosterone hormone therapy, with or without cosmetic mastectomy, but have not undergone complete mastectomy. 3. Persons who have undergone breast cancer screening before can participate. 4. Individuals who meet criteria for above eligibility and are ≥30-39 years of age with a 1st or 2nd degree family member with breast cancer. 5. Ability to speak, read, and write in English. 6. Ability to understand a written informed consent document, and the willingness to sign it. Inclusion Criteria for Breast Radiology Faculty: 1. Board-certified radiologist that specializes in breast imaging and are an actively employed faculty member at Froedtert \& the Medical College of Wisconsin (main campus location). 2. Part of the breast radiology faculty who read both ABUS and MMG of the study participants. 3. Ability to speak, read, and write in English. 4. Ability to understand a written informed consent document, and the willingness to sign it. Inclusion Criteria for Breast Radiology Staff: 1. Must be either a technician, nurse, or clerical staff that works with the breast radiology team at Froedtert \& the Medical College of Wisconsin (main campus location). 2. Ability to understand a written informed consent document, and the willingness to sign it. 3. Ability to speak, read, and write in English. Exclusion Criteria for Individuals on Hormone Therapy 1. Females who have undergone or planned to undergo a complete mastectomy. 2. Females who are post-menopausal on estrogen +/- progesterone hormone therapy since it is a well-established risk for breast cancer). 3. A personal history of breast cancer or a known pathogenic gene mutation that increases the risk of breast cancer development (e.g., BRCA1/2, etc.) given that well-defined surveillance and screening recommendations exist for these persons. Exclusion Criteria for Breast Radiology Faculty 1. Not a board-certified radiologist. 2. Does not specialize in breast imaging. 3. Does not read ABUS and MMG and/or has not read imaging for study participants. Exclusion for Breast Radiology Staff 1\. Does not work with the breast radiology team.
A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer
NCT07766018
Recruiting
Conditions Breast Cancer
Phase PHASE2
Enrollment 70
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-09-09
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Study Details Design, interventions, and primary outcomes

About This Study

This is a multicenter, open-label, Phase 2 bridging study to evaluate the efficacy and safety of elacestrant in Japanese post-menopausal women and men with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer with estrogen receptor 1 gene mutation (ESR1-mut) whose disease has relapsed or progressed on at least 1 and no more than 2 prior lines of endocrine therapy for metastatic breast cancer, which must have included cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy in combination with fulvestrant or an aromatase inhibitor.

Design

Study type: Interventional Phases: Phase2 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Drug: Elacestrant — Administered as an oral tablet

Primary Outcomes

  • Progression-free Survival as Assessed by the Imaging Review Committee (Up to approximately 27 months)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2026-08
Completion: 2028-10
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 70 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Stemline Therapeutics, Inc.
Principal Investigators:
  • Medical Director (STUDY_DIRECTOR) - Stemline Therapeutics, Inc.
Contact Information
Study Contact:
Stemline Trials
1-877-332-7961
clinicaltrials@menarinistemline.com
Interventions
  • Drug: Elacestrant — Administered as an oral tablet
Study Locations (1 sites)
Tokai University Hospital, Isehara, Japan
Eligibility Criteria
Key Inclusion Criteria: * Must have a histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy * Female participants must be post-menopausal (as defined by the protocol) * Must have ER+ and HER2- tumor status confirmed per local laboratory testing * Participants must be ESR1-mutant positive determined via testing with the Guardant360 Companion Diagnostic panel test prior to enrollment * Must have disease progression during or within 28 days of completion of prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (this counts as a line of prior endocrine therapy) for metastatic breast cancer Key Exclusion Criteria: * Prior treatment with: elacestrant or investigational or approved selective estrogen receptor degrader or ER antagonist; antibody-drug conjugate therapy for advanced/metastatic breast cancer; anti-cancer or investigational drug treatment * Radiation therapy within 14 days (28 days for brain lesions) before the first dose of study drug * Intact uterus with a history of endometrial intraepithelial neoplasia (atypical endometrial hyperplasia or higher-grade lesion) * Diagnosis of any other malignancy within 5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or second primary breast cancer Note: Other protocol-defined inclusion/exclusion criteria may apply.
Hypofractionated LocoRegional Radiotherapy in Breast Cancer
NCT04228991
Active, positions filled
Conditions Breast Neoplasms, Radiotherapy, Lymphede...
Phase PHASE3
Enrollment 588
Locations 20 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

The primary objective of this study is to determine if hypofractionated RT delivered over 1 week to the breast or chest wall and regional nodes (26Gy in 5 daily fractions) following BCS or mastectomy, is non-inferior to conventional fractionation to the breast or chest wall and regional nodes delivered over 3 weeks (40Gy in 15 daily fractions) in patients with node-positive breast cancer.

Design

Study type: Interventional Phases: Phase3 Allocation: Randomized Intervention model: Parallel Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Radiation: Locoregional radiation treatment - Conventional fractionation — 40 Gray in 15 daily fractions over 3 weeks
  • Radiation: Locoregional radiation treatment - Hypofractionation — 26 Gray in 5 daily fractions over 1 week

Primary Outcomes

  • Lymphedema (3 years post randomization)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Active, positions filled
Start Date: 2021-02-10
Completion: 2030-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 588 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Ontario Clinical Oncology Group (OCOG)
Collaborators: Canadian Institutes of Health Research (CIHR), McMaster University
Principal Investigators:
  • Timothy Whelan, MD (PRINCIPAL_INVESTIGATOR) - Juravinski Cancer Centre, McMaster University, Hamilton
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Radiation: Locoregional radiation treatment - Conventional fractionation — 40 Gray in 15 daily fractions over 3 weeks
  • Radiation: Locoregional radiation treatment - Hypofractionation — 26 Gray in 5 daily fractions over 1 week
Study Locations (20 sites)
Tom Baker Cancer Centre, Calgary, Alberta T2N 4N2 Canada
Cross Cancer Institute, Edmonton, Alberta T6G 1Z2 Canada
BC Cancer - Centre for the Southern Interior, Kelowna, British Columbia V1Y 5L3 Canada
BC Cancer - Centre for the North, Prince George, British Columbia Canada
BC Cancer - Vancouver Centre, Vancouver, British Columbia V5Z 4E6 Canada
BC Cancer - Vancouver Island Centre, Victoria, British Columbia V8R 6V5 Canada
Northeast Cancer Centre, Health Sciences North, Greater Sudbury, Ontario P3E5J1 Canada
Juravinski Cancer Centre, Hamilton, Ontario L8V 5C2 Canada
London Regional Cancer Program, London, Ontario N6A 5W9 Canada
The Ottawa Hospital Regional Cancer Centre, Ottawa, Ontario K1H 8L6 Canada
Eligibility Criteria
Inclusion Criteria: 1. Newly diagnosed invasive carcinoma of the breast. 2. Treated with definitive surgery (BCS or mastectomy with nodal staging using SLNB or ALND) with clear margins of excision.\* Note: \*Patients with limited positive posterior margin where disease is resected to chest wall or limited positive anterior margin where disease is resected to dermis are eligible. 3. Candidate for locoregional radiotherapy: breast cancer stage after definitive surgery: * Neoadjuvant chemotherapy was not administered: pathologic stage T3N0,T1-3 N1-2\*\* \*\* patients with nodal micromets (N1mi) are eligible * Neoadjuvant chemotherapy was administered: clinical stage T3N0, T1-3, N1-2 and pathologic stage T0-3, N0-2† * Patients who are clinically N1-2 prior to chemotherapy should be confirmed histologically unless it is clear that they are node positive. Patients who are deemed node negative prior to chemotherapy but are node positive following chemotherapy are eligible. Patients who are node positive prior to chemotherapy and who have complete response in the lymph nodes are also eligible. 4. No evidence of metastatic disease. Exclusion Criteria: 1. Age \< 18 years. 2. Clinical stages T4 and/or N3. 3. Clinical lymphedema in the ipsilateral arm or breast/chest wall. 4. Any prior history, not including index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy. (Patients with previous ipsilateral DCIS or LCIS not treated with radiation are eligible.) 5. Synchronous or previous contralateral breast cancer.(Patients with previous contralateral DCIS or LCIS not treated with radiation are eligible.) 6. History of non-breast malignancy within the last 5 years other than non-melanoma skin cancer or treated in-situ carcinoma. 7. Neoadjuvant endocrine therapy. (Extended neoadjuvant endocrine therapy is not permitted. Endocrine therapy exposure for 12 weeks or less prior to surgery is acceptable.) 8. Breast reconstruction. 9. Presence of known medical conditions that would preclude follow-up for 5 years. 10. Previous radiotherapy to the ipsilateral breast or chest wall or serious non-malignant disease e.g. scleroderma, severe lung or heart disease that would preclude radiotherapy. 11. Known pregnancy or currently lactating. 12. Geographic inaccessibility for follow-up. 13. Inability to provide informed consent.
Uptake of Genetic Counseling Among African American Women
NCT04082117
Active, positions filled
Conditions Breast Cancer Risk
Phase NA
Enrollment 960
Locations 2 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

A feasibility study incorporating an educational intervention with cancer genetic risk assessment (CGRA) in the UI Health mammography center

Design

Study type: Interventional Phases: Allocation: Intervention model: Single Group Primary purpose: Other Masking/blinding: None

Interventions / Regimen

  • Behavioral: Educational video — Educational genetic counseling video

Primary Outcomes

  • Knowledge and intentions regarding genetic counseling (1 hour)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2017-05-12
Completion: 2026-05
Eligibility
Age: 25 Years
Sex: FEMALE
Volunteers: false
Enrollment: 960 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Illinois at Chicago
Principal Investigators:
  • Kent Hoskins, M.D. (PRINCIPAL_INVESTIGATOR) - University of Illinois at Chicago
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Behavioral: Educational video — Educational genetic counseling video
Study Locations (2 sites)
University of Illinois Health System, Chicago, Illinois 60612 United States
University of Illinois, Chicago, Illinois 60612 United States
Eligibility Criteria
Inclusion Criteria: * African American female age 25-69 years * Presenting for mammogram at UI Health mammography clinic * No prior history of breast cancer * Completed cancer genetic risk assessment (CGRA) in UI Health mammography center * Recommended for genetic counseling based on CGRA performed at the time of the mammogram. Exclusion Criteria: * Unable to complete the informed consent and survey in English * Previously had genetic counseling for hereditary breast cancer risk * Prisoners
Effects of Ketone Ester Consumption on Exercise Tolerance and Cardiac Function
NCT06078683
Recruiting
Conditions Type 2 Diabetes, Ketone Body Metabolism,...
Phase NA
Enrollment 30
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This study is being done to evaluate how a ketone ester (KE) supplement affects heart function and health in people with diabetes compared to a placebo supplement (made with standard food ingredients that do not contain ketone esters).

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Crossover Primary purpose: Basic Science Masking/blinding: Triple

Interventions / Regimen

  • Dietary Supplement: Ketone Ester Acute — Participants will undertake a controlled feeding intervention where they will consume 25g of C8 Ketone Diester with a meal, and images obtained before and after consumption. The supplement powder contains 12.5 g C8 Diester, sodium caseinate and soluble corn fiber, per serving. The powder contains 120 kcal, 0 g fat, 3 g carbohydrate, and 0 g protein. A standardized meal will be provided to subjects to consume with their allocated supplement during the MRI visits. This meal is formulated with whole foods (i.e. chicken, rice, and a fruit bar) as a mix of macronutrients (29% protein, 3% fat, and 68% carbohydrate - not including the supplements). The meal consists of \~700kcal of food and will be standardized between all visits and subjects.
  • Dietary Supplement: Placebo Acute — Participants will undertake a controlled feeding intervention where they will drink two servings of the placebo with a meal, and images obtained before and after consumption. The placebo is flavor, energy, volume, and macronutrient matched will be given to patients as part of the placebo arm of the study. This placebo will not contain any BHB, which will be replaced with a similar caloric content of fat in the form of canola oil.

Primary Outcomes

  • Change in Cardiac MRI measures of cardiac function (Baseline, 2 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-06-06
Completion: 2027-08-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Ohio State University
Principal Investigators:
  • Yuchi Han, MD, MMSc (PRINCIPAL_INVESTIGATOR) - Ohio State University
Contact Information
Study Contact:
Debbie Scandling, BS
614-688-5623
debbie.scandling@osumc.edu
Christopher Crabtree, MS
crabtree.223@osu.edu
Interventions
  • Dietary Supplement: Ketone Ester Acute — Participants will undertake a controlled feeding intervention where they will consume 25g of C8 Ketone Diester with a meal, and images obtained before and after consumption. The supplement powder contains 12.5 g C8 Diester, sodium caseinate and soluble corn fiber, per serving. The powder contains 120 kcal, 0 g fat, 3 g carbohydrate, and 0 g protein. A standardized meal will be provided to subjects to consume with their allocated supplement during the MRI visits. This meal is formulated with whole foods (i.e. chicken, rice, and a fruit bar) as a mix of macronutrients (29% protein, 3% fat, and 68% carbohydrate - not including the supplements). The meal consists of \~700kcal of food and will be standardized between all visits and subjects.
  • Dietary Supplement: Placebo Acute — Participants will undertake a controlled feeding intervention where they will drink two servings of the placebo with a meal, and images obtained before and after consumption. The placebo is flavor, energy, volume, and macronutrient matched will be given to patients as part of the placebo arm of the study. This placebo will not contain any BHB, which will be replaced with a similar caloric content of fat in the form of canola oil.
Study Locations (1 sites)
The Ross Heart Hospital, Columbus, Ohio 43210 United States
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years old and ≤ 80 years old 2. Type II Diabetes Mellitus 3. Stable medical therapy for at least 1 months as determined by the treating physician (no plan to change between the two testing sessions) 4. Dose of oral diuretics changes allowed, but must be stable for 1 week prior to randomization 5. Body Mass Index (BMI) ≥ 25 6. Ability to participate in exercise treadmill testing (only if CPET is performed) 7. Ability to sign written consent Exclusion Criteria: 1. Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the trial 2. Known allergy or sensitivity to Gadolinium based contrast agents 3. Implanted pacemaker, cardioverter defibrillator, cardiac resynchronization therapy, left ventricular assist device 4. Other metallic implants/aneurysm clips that are contraindicated in MRI 5. Claustrophobia 6. History of severe kidney disease with eGFR\<30 ml/kg/1.73m2 7. Type I diabetes 8. History of diabetic ketoacidosis 9. Prior diagnosis of oxygen dependent pulmonary disease 10. Body Mass Index (BMI) \< 25 11. Major surgery (major according to the investigator's assessment) performed within 90 days prior to screening, or major scheduled elective surgery (e.g. hip replacement) within 90 days after screening 12. Acute or chronic liver disease, defined by serum levels of transaminases or alkaline phosphatase more than three times the upper limit of normal at screening 13. Gastrointestinal surgery or gastrointestinal disorder that might interfere with supplement consumption. Prior bariatric surgery allowed if weight-stable for past 3 months. 14. Any documented active or suspected malignancy or history of malignancy within 2 years prior to screening, except appropriately treated basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix, or low-risk prostate cancer (subjects with pre-treatment prostate-specific antigen levels of \<10 ng/mL, and biopsy Gleason scores of ≤6 and clinical stage T1c or T2a) 15. Presence of any disease other than diabetes that results in a life expectancy of \<1 year (in the opinion of the investigator) 16. Current enrolment in another investigational device or drug study or completion within \<30 days of a trial of another investigational device or drug study. 17. Chronic alcohol or drug abuse or any condition that, in the investigator's opinion, will make the subject unlikely to fulfil the trial requirements or complete the trial 18. Any other clinical condition that might jeopardize subject safety during participation in this trial or prevent the subject from adhering to the trial Protocol. 19. Unable or unwilling to follow guidelines of assigned supplement group. 20. Allergy to test article ingredients, or lactose intolerance 21. The subject cannot currently be on a low-carb diet plan. 30-day washout would be required. 22. Refusal to consent
BioDulse II: The Effect of an Irish Seaweed Protein Extract on Glucose Control in Adults With Type 2 Diabetes
NCT05986253
Active, positions filled
Conditions Type 2 Diabetes
Phase NA
Enrollment 10
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

Co-ingesting protein with carbohydrate is an effective way to improve postprandial glucose handling. The investigators have isolated and identified a bioactive protein extracted from seaweed. The investigators aim to explore how varying doses of seaweed protein influence postprandial glycaemia and insulinaemia in a population with type 2 diabetes.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Crossover Primary purpose: Basic Science Masking/blinding: Single

Interventions / Regimen

  • Dietary Supplement: Seaweed protein — Novel protein extracted from seaweed
  • Dietary Supplement: Maltodextrin — maltodextrin solution

Primary Outcomes

  • Postprandial blood glucose area under the curve (AUC) (120 minutes)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Active, positions filled
Start Date: 2023-08-07
Completion: 2031-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 10 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Limerick
Principal Investigators:
  • Brian Carson, PhD (PRINCIPAL_INVESTIGATOR) - University of Limerick
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Dietary Supplement: Seaweed protein — Novel protein extracted from seaweed
  • Dietary Supplement: Maltodextrin — maltodextrin solution
Study Locations (1 sites)
University of Limerick, Limerick, V94 T9PX Ireland
Eligibility Criteria
Inclusion Criteria: * Aged 18-67 Exclusion Criteria: * Terminal disease * Exclusively receiving enteral or parenteral nutrition * Any conditions/anomalies that are contraindications to bioelectrical impedance analysis as per institutional risk assessment and standard operating procedures * Past medical history of cancer, neurological, kidney, pulmonary, digestive (Coeliac disease), thyroidal disease, cognitive impairment
Assessing Gut Microbiome Changes Before and After an Oral Nutritional Supplement Intake Using the SIMBA Capsule in Diabetic Participants
NCT06704022
Not yet recruiting
Conditions Type 2 Diabetes
Phase PHASE1
Enrollment 30
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

This is a single-arm interventional clinical study, the primary objective is to assess the changes in the small intestinal (SI) metagenomic profile of in diabetic participants from baseline to midpoint and endpoint in response to the ONS intervention. The study population is Type 2 Diabetes (T2D) participants (n=30) who will ingest an Oral Nutritional Supplement (ONS) .

Design

Study type: Interventional Phases: Phase1 Allocation: Intervention model: Single Group Primary purpose: Treatment Masking/blinding: None

Interventions / Regimen

  • Dietary Supplement: Oral nutritional supplement — Consumption of the oral nutritional supplement

Primary Outcomes

  • Primary Outcome (Compared at intervention from baseline, midpoint, to endpoint (completion), an average of 6 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Not yet recruiting
Start Date: 2025-09
Completion: 2026-08
Eligibility
Age: 40 Years
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Nimble Science Ltd.
Collaborators: Alberta Obesity Centre
Contact Information
Study Contact:
Gwen Duytschaever, PhD
8664934633
clinical@nimblesci.com
Isaac Wong, MBT
8664934633
clinical@nimblesci.com
Interventions
  • Dietary Supplement: Oral nutritional supplement — Consumption of the oral nutritional supplement
Study Locations (1 sites)
Nimble Science, Calgary, Alberta T2L 1Y8 Canada
Eligibility Criteria
Inclusion Criteria: 1. Aged 40-65 years old at the inclusion of the study, both female and male subjects. 2. Has type 2 diabetes as evidenced by their medical history charts and is able to maintain number of medications, type and dose throughout the duration of the study. 3. Has HbA1c ≥ 6.5% and ≤ 9.5% based on a blood sample collected at the Screening Visit, documented within the past month or referred by a medical doctor. 4. Normal to overweight (BMI 20-29.9). 5. Weight is stable (has maintained current body weight within 3 kg) for the two months prior to the Baseline Visit. 6. Is taking a maximum of 3 oral anti-diabetic drugs, one of which must be Metformin. Other class of medications permitted include: Sulfonylurea, SGLT2 inhibitors, and DPP4 inhibitors. 7. Either a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to the Baseline Visit. 8. Willingness to follow the protocol as described, including consumption of study product per the protocol and completing any forms/questionnaires needed throughout the study. 9. The participant is willing to refrain from taking non-study diabetes-specific oral nutritional formulas over the entire course of the study. 10. Willing to maintain their diet and physical activity levels during the study. 11. Able to swallow a 25mm length and 9mm width sized capsule. 12. At least a four-week washout period between the completion of a previous research study that required ingestion of any study food or drug and their start in the current study. Signed Informed Consent; willing and able to comply with study procedures Exclusion Criteria: 1. Confirmed type 1 diabetes and/or had a history of diabetic ketoacidosis. 2. Use of exogenous insulin or GLP1 agonists for glucose control. 3. Using diabetes-specific oral nutritional supplements(s), (e.g. Glucerna®, Boost etc.) defined as more than one eating occasion per week within the past 4 weeks (those users who can stop using such products for ≥4 weeks before baseline visit need not be excluded). 4. Follows a non-typical eating pattern such as very low carbohydrate diet (e.g., Adkins diet, ketogenic diet, high protein diet). 5. Has eating disorder, severe dementia or delirium, history of significant neurological or psychiatric disorder, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures in the opinion of the investigators. 6. Galactosemia and lactose intolerance 7. A chronic disease which in the opinion of the investigator, would adversely affect study safety or outcome. Such as, but not limited to * A significant cardiovascular event within 6 months prior to study entry or history of congestive heart failure, per physician evaluation. * End-stage organ failure (such as end-stage renal disease) or is post-organ transplant. * Current or history of renal disease or on dialysis or severe gastroparesis. * Current diagnosed hepatic disease such as liver cirrhosis or late-stage liver fibrosis. Participants with prevalent angina will not be excluded. 8. A chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis C, or HIV. 9. Subject has current active malignant disease or was treated within the last 6 months for cancer, except basal or squamous cell skin carcinoma, prior to enrollment. 10. Taking any herbals, dietary supplements, or medications during the past four weeks prior to baseline visit that could profoundly affect (in the opinion of the principal investigator or site physician) blood glucose, body weight, muscle, metabolism, appetite or microbiome (e.g. orlistat, contrave) (naltrexone/bupropion), Qsymia (phentermine/topiramate), Belviq (lorcaserin), incretin mimetics, other drugs indicated for weight loss, cannabis, glucocorticoids, prebiotics and probiotic supplements). Those users who have stopped using such supplements/ medications for ≥4 weeks prior to baseline need not be excluded). 11. Use of any medications in the week prior to the screening study visit, unless part of regular treatment, that could substantially alter gastrointestinal motor function (e.g., opioids, anticholinergics, GLP-1 analogues); laxative use is allowed if it is kept unchanged in the week prior to the SIMBA capsule ingestion timepoints. Proton pump inhibitors (PPIs) are allowed provided a wash-out period of 48 hours is respected before swallowing the SIMBA capsules and PPI treatment is resumed only 4 hours thereafter. \- If willing prokinetic use can be discontinued for the study duration, with a washout period of 2 weeks 12. Antibiotic use (except for topical use) ≤ 12 weeks prior to screening. Potential participants may be eligible once a 12-week washout is completed. 13. Current infection (requiring medication and antibiotics), inpatient surgery or received systemic corticosteroid treatment \[except for inhaled (includes nasal), topical, and ophthalmic steroids\] in the last 3 months. 14. Prior gastrointestinal disease, surgery, or radiation treatment which, in the Investigator's opinion, would interfere with consumption or digestion or absorption of study product, lead to intestinal structuring or obstruction with a risk of capsule non-excretion, including, e.g., achalasia, eosinophilic esophagitis, cancer diagnosis or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable. \- Diagnosed with Crohn's disease, ulcerative colitis or celiac disease. 15. History of known structural gastrointestinal abnormalities such as structures or fistulas leading to mechanical obstruction. 16. Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome. 17. History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration. 18. History of less than three (3) bowel movements per week. 13) Consumption of probiotic or prebiotic capsule supplements within 1 month prior to screening. Potential participants may be eligible once a 1-month washout is completed. 19. Any prior Fecal Microbiota Transplantation. 20. Colon cleanses/bowel prep for 2 weeks. 21. Clotting or bleeding disorders (the use of Plavix® or a similar anticoagulant drug with no reported difficulty during blood draws will be allowed as per physician's opinion). 22. Has blood or blood-related diseases (e.g. hemophilia, thalassemia, sickle cell disease, hereditary spherocytosis, glucose-6-phosphate dehydrogenase deficiency). 23. Received a blood transfusion within the last 3 weeks. 24. Allergic or intolerant to any ingredient found in the study products. 25. Habitually engages in strenuous exercise (e.g., high intensity aerobic exercise, including heavy physical labor), duration of 1 hour or longer, 3 or more times per week. Potential participants may be eligible to participate if their levels exercise are reduced. 26. Participant is actively enrolled in a weight loss program. 27. Are scheduled for an MRI at any time during the study. Potential participants may be eligible to participate once their MRI procedure is completed. 28. Pregnant or breastfeeding. 29. Planning to become pregnant.
The Use of Statin in Diabetic Patients Not Known to Have Atherosclerotic Cardiovascular Disease
NCT06676683
Not yet recruiting
Conditions Diabete Type 2
Phase Not Applicable
Enrollment 300
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-09-09
Click to view full details
Study Details Design, interventions, and primary outcomes

About This Study

the use of Statin in diabetic patients and its correlation to the guidelines recommendation.

Design

Study type: Observational Observational model: Cohort Time perspective: Prospective

Interventions / Regimen

  • Drug: Usage of Statin in diabetic patients — The use of statin in diabetic patients not known to have Atherosclerotic cardiovascular disease in a low income community

Primary Outcomes

  • changes in lipid profile in response to treatment with statin in diabetc patients (12 Weeks)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Not yet recruiting
Start Date: 2024-12-01
Completion: 2025-12-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 300 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sohag University
Contact Information
Study Contact:
Islam A Hassan, Master
00201033799510
islam_abdelaziz_post@med.sohag.edu.eg
Usama M Abdelaal, Professor
00201065962094
Interventions
  • Drug: Usage of Statin in diabetic patients — The use of statin in diabetic patients not known to have Atherosclerotic cardiovascular disease in a low income community
Study Locations (1 sites)
Sohag university hospital, Sohag, 82524 Egypt
Eligibility Criteria
Inclusion Criteria: * All diabetic \> 18 years. Exclusion Criteria: * Diabetic Patients with known to have Atherosclerotic cardiovascular disease.