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Showing 12 of 4196 trials

Remote Hypertension Management for Black Patients

NCT06527794
Recruiting
Conditions Uncontrolled Hypertension
Phase NA
Enrollment 864
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-09
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Study Details Design, interventions, and primary outcomes

About This Study

This study will compare two approaches for managing hypertension in Black patients with uncontrolled blood pressure (BP). One approach will include home BP telemonitoring supported by a pharmacist and a community health worker. The other approach will include usual clinic-based care along with a home BP monitor and routine care.

Design

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

Interventions / Regimen

  • Behavioral: RHYTHM (Remote Hypertension Tracking Help Management) — Home blood pressure telemonitoring with remote medication management by a centralized multidisciplinary team led by a pharmacist; and social support, lifestyle education and connection to community resources to address social needs, provided by a community health worker who is embedded with the centralized team and is tightly connected to community resources and partners
  • Behavioral: Enhanced usual care (UC) — All participating sites will receive training on appropriate blood pressure measurement and education on guideline-based hypertension therapy. Additionally, participants in usual care will receive a standardized packet with evidence-based hypertension education material and a blood pressure monitor to complete blood pressure measurements at home.

Primary Outcomes

  • Blood pressure control - Percent of patients achieving BP control (i.e., Systolic BP<130mmHg) - Month 12 (Month 12)
Interested in this trial?
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-12-13
Completion: 2028-09
Eligibility
Age: 21 Years – 85 Years
Sex: ALL
Volunteers: false
Enrollment: 864 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Wake Forest University Health Sciences
Collaborators: Patient-Centered Outcomes Research Institute
Principal Investigators:
  • Yhenneko J. Taylor, PhD (PRINCIPAL_INVESTIGATOR) - Wake Forest University Health Sciences
Contact Information
Study Contact:
Yhenneko J. Taylor, PhD
(704) 355-6562
Yhenneko.Taylor@advocatehealth.org
Asha Ganesan
asha.ganesan@advocatehealth.org
Yhenneko Taylor, PhD
704-355-6562
Yhenneko.Taylor@atriumhealth.org
Wake Forest University Health Sciences
Interventions
  • Behavioral: RHYTHM (Remote Hypertension Tracking Help Management) — Home blood pressure telemonitoring with remote medication management by a centralized multidisciplinary team led by a pharmacist; and social support, lifestyle education and connection to community resources to address social needs, provided by a community health worker who is embedded with the centralized team and is tightly connected to community resources and partners
  • Behavioral: Enhanced usual care (UC) — All participating sites will receive training on appropriate blood pressure measurement and education on guideline-based hypertension therapy. Additionally, participants in usual care will receive a standardized packet with evidence-based hypertension education material and a blood pressure monitor to complete blood pressure measurements at home.
Study Locations (1 sites)
Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157 United States
Eligibility Criteria
Inclusion Criteria: * Black or African American race * Hypertension diagnosis * aged 21 to 85 years * Uncontrolled blood pressure as defined by \[a\] most recent SBP ≥140 mmHg and an additional SBP≥140 mmHg within the past 12 months in an outpatient setting (excluding urgent care, emergency department or surgery clinic), or \[b\] most recent SBP\>160mmHg in an outpatient setting (excluding urgent care, emergency department or surgery clinic), or \[c\] referral by PCP for uncontrolled hypertension with at least one documented SBP≥140 mmHg (in clinic or at home) in the past 12 months; and (v) primary care provided at a participating clinic. * Able to speak English * Primary care provided at a participating clinic Exclusion Criteria: * currently pregnant or planning to get pregnant during the study period * residence in a long-term care facility, hospice or with a terminal illness with less than 1 year life expectancy as determined by the Primary Care Physician or study team. Stable chronic illness such as compensated cirrhosis, chronic obstructive pulmonary disease, congestive heart failure etc. will not be excluded. * estimated Glomerular Filtration Rate (eGFR) \<30 ml/min or on dialysis. Patients with a functioning kidney transplant will not be excluded. * inability to provide informed consent or participate in study procedures. For example, conditions that limit ability to participate in phone visits or check BPs in at least one arm. * currently participating in another BP management program. * plan to move out of the area within the next 12 months. * Hispanic ethnicity.

Study of SYN818 for the Treatment of Advanced or Metastatic Solid Tumors

NCT06666270
Recruiting
Conditions Advanced Solid Cancer, Metastatic Solid ...
Phase PHASE1
Enrollment 30
Locations 2 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-09
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Study Details Design, interventions, and primary outcomes

About This Study

This interventional study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of SYN818 as monotherapy in adult patients with advanced solid tumors

Design

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

Interventions / Regimen

  • Drug: SYN818 — Patients will orally receive SYN818

Primary Outcomes

  • Number of participants with Dose Limiting Toxicities (DLTs) (From first dose of study treatment until the end of Cycle 1 (each cycle is 21-days))
  • Number of participants experiencing adverse events (AEs)/serious adverse events (SAEs) (From time of information consent to 30 days post last dose, up to 3 years)
  • Maximum tolerated dose (MTD) (Up to 3 years)
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE1
Status: Recruiting
Start Date: 2024-11-21
Completion: 2026-12-30
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Hangzhou SynRx Therapeutics Biomedical Technology Co., Ltd
Contact Information
Study Contact:
Tongfu Xu, PHD
+86-571-86360796
xutongfu@synrx.cn
Min Yan, MD, PhD
+86-371-65588007
ym200678@126.com
Henan Cancer Hospital
Hongxia Wnag, MD, PhD
+86-21-64175590
whx365@126.com
Fudan University Shanghai Cancer Center.
Interventions
  • Drug: SYN818 — Patients will orally receive SYN818
Study Locations (2 sites)
Henan Cancer Hospital, Zhengzhou, Henan 450008 China
Fudan University Shanghai Cancer Center., Shanghai, Shanghai Municipality 200032 China
Eligibility Criteria
Inclusion Criteria: * Having signed the written Informed Consent Form (ICF); * Male or female aged ≥18 years; * Life expectancy ≥12 weeks; * Eastern Cooperative Oncology Group (ECOG) Performance Score 0 or 1; * Patients with histologically or cytologically confirmed locally advanced or metastatic breast cancer, ovarian cancer, prostate cancer or other advanced solid tumors who have experienced disease progression, and available SOC therapies had been exhausted; * be willing to provide tumor tissue samples (fresh frozen \[SF\] or previously retained paraffin-embedded \[FFPE\] tumor tissue samples) or peripheral blood germline DNA or ctDNA sample to detect BRCA mutation, or other deficiency in the HR pathway (by the detection method of next generation sequencing \[NGS\]) * At least one measurable lesion according to RECIST v1.1; * No serious hematological, cardiopulmonary, or liver or kidney diseases other than the primary disease; * Adequate organ function and bone marrow function. Exclusion Criteria: * Previous or current use of POLQ inhibitors; * Hypersensitivity to the active pharmaceutical ingredient or any excipient of SYN818; * Central nervous system (CNS) metastasis or meningeal metastasis with clinical symptoms, or other evidence indicating that CNS metastasis or meningeal metastasis has not been adequately controlled; * Other malignant tumors than the study tumors within 5 years prior to the first dose of the study drug, except for localized cancers that have been evidently cured or disease-free for at least 3 years, such as basal or squamous cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, carcinoma in situ of cervix, or carcinoma in situ of breast; * Patients with Myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) or with features suggestive of MDS/AML; * Dysphagia or refractory nausea and vomiting, malabsorption, extracorporeal biliary shunts, or gastrointestinal disorders that affect drug absorption, e.g., Crohn's disease, ulcerative colitis, or short bowel syndrome, or other malabsorption conditions; * Major surgery or serious trauma within 4 weeks prior to the first dose of the study treatment or major surgery planned during the trial period, and none of the AEs related to surgery or major trauma have resolved (to ≤ CTCAE v5.0 Grade 1 or baseline level) before the first dose of the study drug; * History of use within 2 weeks prior to the first dose of the study treatment and need to use protocol-prohibited potent inhibitors or potent inducers of cytochrome P450 (CYP) 3A4/BCRP/P-gp during the study; * Serious systemic diseases or laboratory abnormalities or other conditions that, at the Investigator's discretion, will make it unsuitable for the patient to participate in this clinical trial.

Fovinaciclib Plus Aromatase Inhibitors and Dual HER2 Blockade in a Response-Adapted Neoadjuvant Strategy for HR-Positive/HER2-Positive Early Breast Cancer

NCT07616427
Recruiting
Conditions HR+/HER2+ Early Breast Cancer
Phase PHASE2
Enrollment 100
Locations 3 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-09
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Study Details Design, interventions, and primary outcomes

About This Study

This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant fovinaciclib in combination with aromatase inhibitors and dual HER2 blockade in patients with HR-positive/HER2-positive early breast cancer. All patients initially receive induction treatment with fovinaciclib plus endocrine therapy and HER2-targeted therapy, followed by early assessment of treatment response after 6 weeks of treatment. Patients demonstrating an adequate response continue the same regimen, whereas those with a suboptimal response are transitioned to standard neoadjuvant chemotherapy combined with HER2-targeted therapy prior to surgery. This adaptive approach aims to optimize treatment selection, improve therapeutic efficacy, and reduce unnecessary chemotherapy exposure.

Design

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

Interventions / Regimen

  • Drug: Fovinaciclib — CDK4/6 inhibitor
  • Drug: Aromatase Inhibitors — Letrozole or anastrozole
  • Drug: Trastuzumab + Pertuzumab — dual HER2 blockade

Primary Outcomes

  • Total Pathological Complete Response (tpCR) Rate: ypT0/Tis, ypN0 (24 weeks)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2026-05-20
Completion: 2033-05-20
Eligibility
Age: 18 Years – 75 Years
Sex: FEMALE
Volunteers: false
Enrollment: 100 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine
Contact Information
Study Contact:
Yunxiang Zhou
15868131018
yxzhou@zju.edu.cn
Xiaoan Liu
025-83718836
liuxiaoan@126.com
The First Affiliated Hospital of Nanjing Medical University
Xiaoan Liu
The First Affiliated Hospital of Nanjing Medical University
Interventions
  • Drug: Fovinaciclib — CDK4/6 inhibitor
  • Drug: Aromatase Inhibitors — Letrozole or anastrozole
  • Drug: Trastuzumab + Pertuzumab — dual HER2 blockade
Study Locations (3 sites)
The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu 210029 China
2nd Affiliated Hospital, School of Medicine, Hangzhou, Zhejiang 310009 China
Ningbo No. 2 Hospital, Ningbo, Zhejiang 315010 China
Eligibility Criteria
Inclusion Criteria Subjects voluntarily agree to participate in the study, fully understand the study procedures, provide written informed consent (ICF), and are willing and able to comply with all study procedures. Female patients aged ≥18 years and ≤75 years. Histologically confirmed HR-positive (ER \>10%) and HER2-positive (IHC 3+ or IHC 2+/ISH+) early-stage or locally advanced invasive breast cancer. Pathologically staged as stage I-III according to the American Joint Committee on Cancer (AJCC) 8th edition staging system. Premenopausal patients must receive ovarian function suppression. Considered suitable for aromatase inhibitor treatment according to investigator assessment. Presence of evaluable disease according to RECIST version 1.1, including measurable and/or non-measurable lesions. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. Ability to swallow capsules. Adequate bone marrow and organ function, defined as follows: Absolute neutrophil count (ANC) ≥1.5 × 10\^9/L; Hemoglobin ≥100 g/L (without red blood cell transfusion within 14 days prior to randomization); Platelet count ≥100 × 10\^9/L; Total serum bilirubin ≤1.5 × upper limit of normal (ULN); patients with Gilbert syndrome must have total bilirubin ≤3 × ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN; Serum creatinine \<1.5 × ULN or creatinine clearance ≥50 mL/min; Left ventricular ejection fraction (LVEF) ≥50%; QT interval ≤480 ms. Exclusion Criteria Current participation in another clinical trial involving investigational therapy, or participation in any other medical study considered scientifically or medically incompatible with this study. Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer. History of uncontrolled seizures or central nervous system disease. History of other malignancies within the past 5 years. Pregnant or breastfeeding women. Known severe hypersensitivity to any component of the study drugs. Severe comorbidities, including uncontrolled hypertension (e.g., systolic blood pressure \>180 mmHg or diastolic blood pressure \>100 mmHg), uncontrolled diabetes mellitus, or active infection. Patients with adequately controlled hypertension may be enrolled. Clinically uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage or medical intervention within 2 weeks prior to first dosing. Myocardial infarction within 6 months prior to first dosing; uncontrolled arrhythmia (QTc ≥470 ms, calculated using Fridericia's formula); New York Heart Association (NYHA) class III-IV heart failure; LVEF \<50%; or clinically significant pleural effusion, pericardial effusion, or ascites requiring intervention. Dysphagia, active gastrointestinal disease, history of major gastrointestinal surgery, malabsorption syndrome, or any condition that may affect absorption of study drugs. Active hepatitis B infection \[HBsAg-positive with detectable HBV-DNA\], active hepatitis C infection \[HCV antibody-positive with detectable HCV-RNA\], positive syphilis screening (except confirmed inactive infection), known HIV infection, or positive HIV screening result. Receipt of major surgery, radiotherapy, tumor immunotherapy, monoclonal antibody-based antitumor therapy, or other systemic antitumor therapies considered by the investigator to interfere with study treatment efficacy within 28 days prior to first dosing. Planned or previous organ transplantation or bone marrow transplantation. Known history of psychiatric substance abuse or drug addiction. Any other condition that, in the investigator's judgment, would make the subject unsuitable for participation in the study.

Brain Metastasis Development Mechanism in BCBM Patients

NCT06330870
Recruiting
Conditions Breast Cancer, Brain Metastasis
Phase NA
Enrollment 30
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-09
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This study is the experimental study for brain metastasis development mechanism in patients with breast cancer with brain metastasis

Design

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

Interventions / Regimen

  • Procedure: WGS/TME evaluation — WGS/TME evaluation with blood and brain metastasis tissue during brain metastasis curative surgery

Primary Outcomes

  • Intracranial disease free survival (Months)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2023-04-06
Completion: 2027-12-31
Eligibility
Age: Not reported
Sex: FEMALE
Volunteers: false
Enrollment: 30 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Samsung Medical Center
Contact Information
Study Contact:
Ji-Yeon Kim
82-2-3410-3459
jyeon25@skku.edu
Mee Ryung Hong
82-2-2148-7147
ring7629@naver.com
Ji-Yeon Kim
Ji-Yeon Kim
Interventions
  • Procedure: WGS/TME evaluation — WGS/TME evaluation with blood and brain metastasis tissue during brain metastasis curative surgery
Study Locations (1 sites)
Ji-Yeon Kim, Seoul, 06351 South Korea
Eligibility Criteria
Inclusion Criteria: * Breast cancer * Brain metastasis curative surgery patient Exclusion Criteria: * Gamma Knife surgery patient

Longitudinal Sexual and Reproductive Health Study of Women With Breast Cancer and Lymphoma

NCT01788839
Recruiting
Conditions Breast Cancer, Lymphoma, Hodgkin's Lymph...
Phase Not Applicable
Enrollment 475
Locations 7 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-09
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The purpose of this study is to see how cancer treatment affects sexual and reproductive function. The patient will also be asked to participate in blood draws to see if and how cancer treatment affects the ovaries and the ability to have children (fertility). These blood draws are optional and the patient can still participate in the questionnaire portion of the study even if they choose not to have their blood drawn.

Design

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

Interventions / Regimen

  • Behavioral: surveys — A survey including the Female Sexual Function Index (FSFI), the Modified Female Sexual Function Index (FSFI-M), the Modified Female Sexual Function Index Follow-Up (FSFI-M Follow-Up) the Sexual Activity Questionnaire (SAQ), the Female Sexual Distress Scale (FSDS-R), the Menopausal Symptom Check List (MSCL), Patient-reported Outcomes Measurement Information System Sexual Function Instrument (PROMIS-SF), Abbreviated Dyadic Adjustment Scale for Relationships (ADAS), Reproductive Health Survey-baseline (RHS-B). Reproductive Health Survey-followup and (RHS-F1)Reproductive Health Survey-followup (RHS-F2) will be conducted at the following intervals: baseline/before chemotherapy +/- 1 month, 3 months after baseline +/- 1 month, 6 months after baseline +/- 1 month, 1 year after baseline +/- 1 month, and at intervals during survivorship that include yearly for 5 years +/- 2 months.
  • Other: Blood draw — Those patients receiving chemotherapy who consent to the optional blood draw will provide blood at baseline (before start of chemotherapy), 12 months after baseline (+/-1 month) and 24 months after baseline (+/-2 months). All patients in the subset of the premenopausal cohort receiving tamoxifen only will have required blood draws at baseline (before they begin taking tamoxifen), at 6 months post-baseline/start of tamoxifen (+/- 2 weeks), 12 months post-start of tamoxifen (+/-1 month) and 24 months post-start of tamoxifen (+/-2 months). We will ask these participants for blood draws on day 1, 2, 3 or 4 of their menses at baseline and 6 months post-baseline/start of tamoxifen and during months 1 through 5 post-baseline/start of tamoxifen.
  • Device: Transvaginal ultrasounds — Transvaginal ultrasounds are used to determine the number of antral follicles in each ovary. They will be performed to evaluate both the number and size of antral follicles of premenopausal women on Tamoxifen as antral follicle count is a good predictor of ovarian reserve and response. All patients in the subset of the premenopausal cohort receiving tamoxifen only will also have required transvaginal ultrasounds at baseline (before they begin taking tamoxifen) and at 6 months post-start of tamoxifen (+/- 2 weeks).

Primary Outcomes

  • determine the natural history of sexual and reproductive health (5 years)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2013-02
Completion: 2027-02
Eligibility
Age: 18 Years and older
Sex: FEMALE
Volunteers: false
Enrollment: 475 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Memorial Sloan Kettering Cancer Center
Principal Investigators:
  • Shari Goldfarb, MD (PRINCIPAL_INVESTIGATOR) - Memorial Sloan Kettering Cancer Center
Contact Information
Study Contact:
Shari Goldfarb, MD
646-888-5080
Jeanne Carter, MD
646-888-5076
Shari Goldfarb, MD
646-888-5080
Memorial Sloan Kettering Basking Ridge
Interventions
  • Behavioral: surveys — A survey including the Female Sexual Function Index (FSFI), the Modified Female Sexual Function Index (FSFI-M), the Modified Female Sexual Function Index Follow-Up (FSFI-M Follow-Up) the Sexual Activity Questionnaire (SAQ), the Female Sexual Distress Scale (FSDS-R), the Menopausal Symptom Check List (MSCL), Patient-reported Outcomes Measurement Information System Sexual Function Instrument (PROMIS-SF), Abbreviated Dyadic Adjustment Scale for Relationships (ADAS), Reproductive Health Survey-baseline (RHS-B). Reproductive Health Survey-followup and (RHS-F1)Reproductive Health Survey-followup (RHS-F2) will be conducted at the following intervals: baseline/before chemotherapy +/- 1 month, 3 months after baseline +/- 1 month, 6 months after baseline +/- 1 month, 1 year after baseline +/- 1 month, and at intervals during survivorship that include yearly for 5 years +/- 2 months.
  • Other: Blood draw — Those patients receiving chemotherapy who consent to the optional blood draw will provide blood at baseline (before start of chemotherapy), 12 months after baseline (+/-1 month) and 24 months after baseline (+/-2 months). All patients in the subset of the premenopausal cohort receiving tamoxifen only will have required blood draws at baseline (before they begin taking tamoxifen), at 6 months post-baseline/start of tamoxifen (+/- 2 weeks), 12 months post-start of tamoxifen (+/-1 month) and 24 months post-start of tamoxifen (+/-2 months). We will ask these participants for blood draws on day 1, 2, 3 or 4 of their menses at baseline and 6 months post-baseline/start of tamoxifen and during months 1 through 5 post-baseline/start of tamoxifen.
  • Device: Transvaginal ultrasounds — Transvaginal ultrasounds are used to determine the number of antral follicles in each ovary. They will be performed to evaluate both the number and size of antral follicles of premenopausal women on Tamoxifen as antral follicle count is a good predictor of ovarian reserve and response. All patients in the subset of the premenopausal cohort receiving tamoxifen only will also have required transvaginal ultrasounds at baseline (before they begin taking tamoxifen) and at 6 months post-start of tamoxifen (+/- 2 weeks).
Study Locations (7 sites)
Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey 07920 United States
Memorial Sloan Kettering Monmouth, Middletown, New Jersey 07748 United States
Memorial Sloan Kettering Bergen, Montvale, New Jersey 07645 United States
Memorial Sloan Kettering Commack, Commack, New York 11725 United States
Memorial Sloan Kettering Westchester, Harrison, New York 10604 United States
Memorial Sloan Kettering Cancer Center, New York, New York 10065 United States
Memorial Sloan Kettering Nassau, Uniondale, New York 11553 United States
Eligibility Criteria
Inclusion Criteria: Subject Inclusion Criteria for Cohort of Premenopausal Women with Early Stage Breast Cancer and Lymphoma * Women, 18 years of age and older * Premenopausal women at time of diagnosis who have either been pregnant or had at least one menstrual period in the last 12 months * Note: premenopausal women at time of diagnosis who have not been pregnant or have not had at least one menstrual period in the last 12 months are able to participate only if they have had an intrauterine device (IUD) in place within the last 12 months. * Women with newly diagnosed breast cancer (stage 0-III) who are within 1 month of starting systemic treatment or women with any aggressive lymphoma being treated with first line therapy with curative intent. * Breast cancer patients with any receptor type * English speaking * Able to participate in the informed consent process Subject Inclusion Criteria for Tamoxifen Only Subset of Cohort of Premenopausal Women with Early Stage Breast Cancer and Lymphoma * Women, 18 years of age and older. * Premenopausal women at time of diagnosis who have either been pregnant or had at least one menstrual period in the last 12 months * Note: premenopausal women at time of diagnosis who have not been pregnant or have not had at least one menstrual period in the last 12 months are able to participate only if they have had an intrauterine device (IUD) in place within the last 12 months. * Women with newly diagnosed breast cancer (stage 0-III) who have not yet started treatment and are planning to start Tamoxifen as their only form of systemic treatment within one month * Breast cancer patients with any receptor type * English speaking * Able to participate in the informed consent process Subject Inclusion Criteria for Cohort of Postmenopausal Women with Early Stage Breast Cancer and Lymphoma * Women, 18 years of age and older. * Postmenopausal women at time of diagnosis who have been without period for ≥ 2 years. * Women with newly diagnosed breast cancer (stage 0-III) who are within 1 month of starting systemic treatment or women with any aggressive lymphoma being treated with first line therapy with curative intent. * Breast cancer patients with any receptor type * English speaking * Able to participate in the informed consent process Exclusion Criteria: Subject Exclusion Criteria for both Pre and Postmenopausal Women with Early Stage Breast Cancer and Lymphoma * Active secondary cancer requiring cytotoxic chemotherapy * Prior systemic treatment for a malignancy

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

NCT05334069
Recruiting
Conditions Acute Lymphoblastic Leukemia, Acute Myel...
Phase Not Applicable
Enrollment 2900
Locations 751 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-09
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.

Design

Study type: Observational Observational model: Case Control Time perspective: Prospective

Interventions / Regimen

  • Other: Questionnaire Administration — Complete questionnaire
  • Procedure: Biospecimen Collection — Undergo collection of tissue and blood samples

Primary Outcomes

  • Provision of blinded reference set of cancer versus non-cancer blood samples (Up to 1 year)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2022-08-18
Completion: 2027-02-28
Eligibility
Age: 40 Years – 75 Years
Sex: ALL
Volunteers: true
Enrollment: 2900 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Marie Wood, MD (STUDY_CHAIR) - University of Colorado, Denver
Contact Information
Study Contact:
Marie Wood, MD
(720) 848-0300
marie.wood@cuanschutz.edu
Site Public Contact
907-212-6871
AKPAMC.OncologyResearchSupport@providence.org
Anchorage Associates in Radiation Medicine
Alison K. Conlin
Anchorage Associates in Radiation Medicine
Interventions
  • Other: Questionnaire Administration — Complete questionnaire
  • Procedure: Biospecimen Collection — Undergo collection of tissue and blood samples
Study Locations (751 sites)
Anchorage Associates in Radiation Medicine, Anchorage, Alaska 98508 United States
Anchorage Radiation Therapy Center, Anchorage, Alaska 99504 United States
Alaska Breast Care and Surgery LLC, Anchorage, Alaska 99508 United States
Alaska Oncology and Hematology LLC, Anchorage, Alaska 99508 United States
Alaska Women's Cancer Care, Anchorage, Alaska 99508 United States
Anchorage Oncology Centre, Anchorage, Alaska 99508 United States
Katmai Oncology Group, Anchorage, Alaska 99508 United States
Providence Alaska Medical Center, Anchorage, Alaska 99508 United States
Fairbanks Memorial Hospital, Fairbanks, Alaska 99701 United States
Kingman Regional Medical Center, Kingman, Arizona 86401 United States
Eligibility Criteria
Inclusion Criteria: * Participants with a cancer diagnosis: Documentation of disease: * Histologic documentation: Histologically confirmed diagnosis of invasive cancer * Stage: Stage I-IV per American Joint Committee on Cancer (AJCC) 7th edition, with the exception of patients with leukemia, lymphoma, and multiple myeloma \*\* For leukemia: Type (chronic lymphocytic leukemia \[CLL\], chronic myeloid leukemia \[CML\], acute lymphoblastic lymphoma \[ALL\], acute myeloid leukemia \[AML\]) * For lymphoma (any type): Stage I-IV based on Ann Arbor staging * For multiple myeloma: Stage I, II, III based on Revised International Staging System (RISS) * One of the following tumor types (synchronous cancers are not allowed and all neuroendocrine tumors are excluded): * Colorectal * Bladder * Head and neck * Hepatobiliary \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment * Lung * Lymphoma * Leukemia * Ovary \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment * Pancreas \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment * Multiple myeloma * Gastric, esophageal or gastroesophageal * Breast * Thyroid * Kidney \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment * Endometrium \*\*\* For these specific cancer types only, patients may be enrolled prior to histologic confirmation of malignancy. Sites are required to contact the study chairs to review appropriateness for enrollment * Prostate * Participants with a cancer diagnosis: No prior definitive systemic or local anti-cancer intervention (including surgical excision) * Participants with a cancer diagnosis: Age \>= 40 and =\< 75 * Participants with a cancer diagnosis: No known current pregnancy by self-report * Participants with a cancer diagnosis: No known or prior history of in situ or invasive malignancy other than the current cancer diagnosis. Non-melanoma skin cancers (such as basal or squamous cell) are allowed. * Participants with a cancer diagnosis: Willingness to provide blood samples for research use * Participants with a cancer diagnosis: Absence of medical contraindications to a research blood draw volume of 60 mL * Participants with a cancer diagnosis: No history of organ transplantation * Participants with a cancer diagnosis: Ability to read and comprehend English or Spanish \* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages * Participants without a cancer diagnosis and without suspicion of cancer: Age \>= 40 and =\< 75 * Participants without a cancer diagnosis and without suspicion of cancer: No known current pregnancy by self-report * Participants without a cancer diagnosis and without suspicion of cancer: No known or prior history of in situ or invasive malignancy (excluding in situ non-melanoma skin cancers) * Participants without a cancer diagnosis and without suspicion of cancer: Willingness to provide blood samples for research use * Participants without a cancer diagnosis and without suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL * Participants without a cancer diagnosis and without suspicion of cancer: No history of organ transplantation * Participants without a cancer diagnosis and without suspicion of cancer: Ability to read and comprehend English or Spanish \* Eligibility is restricted to individuals who can comprehend and read English or Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages * Participants with a high suspicion of cancer: High suspicion of ovarian cancer, pancreatic cancer, kidney cancer, hepatobiliary cancer, endometrial cancer or melanoma by clinical and/or radiological assessment, with plans for histologic or cytologic confirmation within 28 days after study blood draw \* Examples of highly suspicious cases include: elevated CA125 and abnormal transvaginal ultrasound, suspicious renal or pancreatic mass on imaging, suspicious cutaneous lesion concerning for melanoma * Participants with a high suspicion of cancer: Central review of radiology reports and/or clinical documentation conducted by study chairs * Participants with a high suspicion of cancer: Age \>= 40 and =\< 75 * Participants with a high suspicion of cancer: No known current pregnancy by self-report * Participants with a high suspicion of cancer: No known or prior history of in situ or invasive malignancy. Non-melanoma skin cancers (such as basal or squamous cell) are allowed. * Participants with a high suspicion of cancer: Willingness to provide blood samples for research use * Participants with a high suspicion of cancer: Absence of medical contraindications to a research blood draw volume of 60 mL * Participants with a high suspicion of cancer: No history or organ transplantation * Participants with a high suspicion of cancer: Ability to read and comprehend English or Spanish \* Eligibility is restricted to individuals who can comprehend and read English and Spanish given that participation in the study will require the ability to read and complete questionnaires that are available only in those two languages

Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer

NCT06405828
Recruiting
Conditions Metastatic Breast Cancer, Stage IV Breas...
Phase NA
Enrollment 67
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-09
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Study Details Design, interventions, and primary outcomes

About This Study

Black and Latina women experience disparities in supportive and palliative care access and outcomes. The goal of the proposed pilot study is to evaluate the feasibility and acceptability of a community navigator delivered supportive care intervention for historically underserved populations of women with metastatic breast cancer.

Design

Study type: Interventional Phases: Allocation: Randomized Intervention model: Parallel Primary purpose: Supportive Care Masking/blinding: Double

Interventions / Regimen

  • Behavioral: ACCESS Supportive Care — ACCESS Supportive Care includes: 1. Coaching sessions: 6 one-hour weekly Community Navigator led supportive and early palliative care health coaching sessions. Sessions will be hybrid (in-person or virtual) per participant preference. 2. Monthly check-in: Monthly check-ins (\~5-10 minutes) about their supportive care and social determinants of health needs over 16 weeks. 3. Scheduling of outpatient supportive oncology appointment if interested. 4. Community linkage: Warm hand offs and connection to community resources to enhance access to support groups, educational workshops, and healthy lifestyle services.
  • Behavioral: Phone sessions — 6 weekly phone sessions, approximately 10 minutes in length each, to review breast cancer and supportive and palliative care resources in NYC and online. The 6 weekly phone sessions will include the topics discussed in the intervention arm but will be informational in nature. The phone sessions will be followed by monthly check-ins (\~5 minutes) to review and answer questions about the resources for the duration of 16 weeks.

Primary Outcomes

  • Number of participants recruited (at 9 months)
  • Number of participants remaining in study (at 9 months)
  • Number of times navigator communicates with oncology team (9 months)
  • Number of times participants connect to resources (9 months)
  • Number of visits (6 months)
  • Number of phone calls (9 months)
  • Number of visits conducted according to the ACCESS manual (9 months)
  • Change in The Impact of Event Scale - Revised (IES-R) scores (Baseline and 9 months)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2024-05-01
Completion: 2027-09-01
Eligibility
Age: 18 Years and older
Sex: FEMALE
Volunteers: false
Enrollment: 67 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Icahn School of Medicine at Mount Sinai
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Melissa Mazor (PRINCIPAL_INVESTIGATOR) - Icahn School of Medicine at Mount Sinai
Contact Information
Study Contact:
Melissa Mazor
(510) 418-8642
melissa.mazor@mountsinai.org
Karisma Pantaleon
212-824-7986.
karisma.pantaleon2@mountsinai.org
Mount Sinai Hospital
Melissa Mazor
Mount Sinai Hospital
Interventions
  • Behavioral: ACCESS Supportive Care — ACCESS Supportive Care includes: 1. Coaching sessions: 6 one-hour weekly Community Navigator led supportive and early palliative care health coaching sessions. Sessions will be hybrid (in-person or virtual) per participant preference. 2. Monthly check-in: Monthly check-ins (\~5-10 minutes) about their supportive care and social determinants of health needs over 16 weeks. 3. Scheduling of outpatient supportive oncology appointment if interested. 4. Community linkage: Warm hand offs and connection to community resources to enhance access to support groups, educational workshops, and healthy lifestyle services.
  • Behavioral: Phone sessions — 6 weekly phone sessions, approximately 10 minutes in length each, to review breast cancer and supportive and palliative care resources in NYC and online. The 6 weekly phone sessions will include the topics discussed in the intervention arm but will be informational in nature. The phone sessions will be followed by monthly check-ins (\~5 minutes) to review and answer questions about the resources for the duration of 16 weeks.
Study Locations (1 sites)
Mount Sinai Hospital, New York, New York 10029 United States
Eligibility Criteria
Inclusion Criteria: * Women ≥18 years of age * English and/or Spanish speaking * Self-identify as Latina and/or African American/Black * Ability to understand and the willingness to sign a written informed consent * Stage IV breast cancer diagnosis, no time component Exclusion Criteria: * Moderate to severe cognitive impairment * receiving inpatient hospice care * if patients were previously enrolled in Aim 1 and Aim 2 * currently working with a community navigator

Minimally Interventional Study on Prevalence of Emerging ESR1 Mutations in Liquid Biopsy in Three Cohorts of Patients With Breast Cancer in Comparison With Patient's Baseline ESR1 Mutation Status as Defined by Tissue Profiling.

NCT06417801
Recruiting
Conditions Metastatic Breast Cancer
Phase Not Applicable
Enrollment 170
Locations 6 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-09
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

Minimally interventional study on prevalence of emerging ESR1 mutations in liquid biopsy in three cohorts of patients with breast cancer (with and without prior therapies in metastatic setting, and during first-line aromatase inhibitor plus CDK4/6 inhibitor therapy) in comparison with patient's baseline ESR1 mutation status as defined by tissue profiling.

Design

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

Primary Outcomes

  • Prevalence of emerging ESR1 mutations (Through study completation, an avarege 2 years)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2024-06-17
Completion: 2027-12-30
Eligibility
Age: 18 Years – 100 Years
Sex: ALL
Volunteers: false
Enrollment: 170 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: AstraZeneca
Principal Investigators:
  • Rodrigo Dienstmann (PRINCIPAL_INVESTIGATOR) - Oncoclínicas
  • Vladmir C. de Lima (PRINCIPAL_INVESTIGATOR) - FUNDAÇÃO ANTONIO PRUDENTE - A.C. CAMARGO CANCER CENTER
  • Tomas Reinert (PRINCIPAL_INVESTIGATOR) - IRMANDADE DA SANTA CASA DE MISERICÓRDIA DE PORTO ALEGRE
Contact Information
Study Contact:
AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com
Interventions
N/A
Study Locations (6 sites)
Ensino E Terapia de Inovação Clínica Amo - Ética, Salvador, Estado de Bahia 41.950-640 Brazil
Irmandade Da Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Rio Grande do Sul 90020-090 Brazil
Fundação Antonio Prudente - A.C. Camargo Cancer Center, São Paulo, 01.509-900 Brazil
Instituto D'Or de Pesquisa E Ensino - São Paulo, São Paulo, 01401-002 Brazil
Research Site, São Paulo, 04513-020 Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Eisntein, São Paulo, 05652-000 Brazil
Eligibility Criteria
Inclusion Criteria: Cohort 1: * BC patients, male and female, * 18 years old and older, * Pre or post menopausal, * With HR+ (ER and/or PR positive) and Her-2 negative (confirmed centrally), * Locally advanced irresectable and/or metastatic disease * Confirmation of HR and Her-2 status may be performed in the primary tumor or in the metastatic lesion (patients with discordant results may be included), * Patients must be candidates to CDK4/6i therapy in combination with endocrine therapy in the first line setting (with or without ovarian suppression) * Patients may have received one previous line of chemotherapy in the metastatic setting, but no endocrine therapy in the metastatic setting is allowed, * Patients may have received chemotherapy in the neo/adjuvant setting, * Patients may have received endocrine therapy (with or without ovarian suppression) in the neo/adjuvant setting, * Patients may have received a CDK4/6i in the adjuvant setting, provided they are still candidates for CDK4/6i therapy in the metastatic setting, * Patients must be able to undergo a liquid biopsy procedure before starting their first line treatment, * All patients must fill and sign an informed consent form. Cohort 2: * BC patients, * Male and female, * 18 years old and older, * pre or post menopausal, * With HR+ (ER and/or PR positive) and Her-2 negative (confirmed centrally), * Locally advanced irresectable and/or metastatic disease who have progressed on a CDK4/6i in combination with endocrine therapy (with or without ovarian suppression) in the first or second line setting, * All other non-conflicting inclusion criteria for cohort 1 apply. Cohort 3: * BC Patients, * Male and female, * 18 years or older, * pre- or post-menopausal, * With HR+ (ER and/or PR positive), HER2-negative (centrally confirmed) locally advanced unresectable and/or metastatic disease, * Confirmation of HR and HER2 status may be performed on the primary tumour or the metastatic lesion (patients with discordant results may be included), * Patients must be on first-line hormonal therapy with an aromatase inhibitor plus a CDK4/6 inhibitor (with or without ovarian suppression) for at least 6 months, * No clinical or radiological evidence of progressive disease, * Patients may have received a prior line of chemotherapy in the metastatic setting; however, prior endocrine therapy in the metastatic setting is not permitted, * Patients may have received chemotherapy in the neoadjuvant/adjuvant setting, * Patients may have received endocrine therapy (with or without ovarian suppression) in the neoadjuvant/adjuvant setting, * Patients may have received a CDK4/6 inhibitor in the adjuvant setting, provided they are still eligible for CDK4/6 inhibitor therapy in the metastatic setting, * Patients must be able to undergo a liquid biopsy procedure before starting their first-line treatment, * All patients must read and sign an Informed Consent Form. Exclusion Criteria: * Patients WITHOUT HR+ (ER- and/or PR-positive)/HER2-negative disease, * Patients without radiological and/or pathological confirmation of locally unresectable and/or metastatic breast cancer, * Patients who are NOT candidates for further systemic treatment following a diagnosis of metastatic disease or disease progression, * Patients who have already started a CDK4/6 inhibitor in combination with endocrine therapy (with or without ovarian suppression) for first-line metastatic disease (for Cohort 1); * Patients who have already started a new line of treatment for metastatic disease following progression on a CDK4/6 inhibitor in combination with endocrine therapy (with or without ovarian suppression) (for Cohort 2); * Patients with any suspicion of clinical or radiological disease progression at the time of the first liquid biopsy collection (for Cohort 3), * Patients who are NOT able to undergo a liquid biopsy procedure, * Patients who are NOT able to provide informed consent.

OPTImaL:Optimisation of Treatment for Patients With Low Stage Triple-negative Breast Cancer With High Stromal Tumor-infiltrating Lymphocytes

NCT06476119
Recruiting
Conditions Breast Cancer Stage I, Triple Negative B...
Phase Not Applicable
Enrollment 490
Locations 28 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-09
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The aim of this study is to investigate whether subjects with breast cancer that have certain favorable features, after performing the surgery and radiation, the chemotherapy can be safely omitted in the treatment. In addition, the investigation looks at whether the omission of chemotherapy ensures a better quality of life. Participants decide, in consultation with their treating physician, whether they choose to be treated with adjuvant chemotherapy or not.

Design

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

Interventions / Regimen

  • Drug: Adjuvant chemotherapy — adjuvant chemotherapy according to local/ national guidelines
  • Other: No adjuvant chemotherapy — no adjuvant chemotherapy

Primary Outcomes

  • Disease recurrence Free Interval (DRFI) - optimalisation cohort per-protocol population (up to 96 months after inclusion of the last patient)
Interested in this trial?
Contact the study team directly or view the official listing
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Study Contact:
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Recruiting
Start Date: 2025-04-15
Completion: 2034-09-15
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 490 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: The Netherlands Cancer Institute
Collaborators: Maarten van de Weijden Foundation, AVL Foundation
Principal Investigators:
  • Marleen Kok, MD (PRINCIPAL_INVESTIGATOR) - Antoni van Leeuwenhoek
Contact Information
Study Contact:
Marleen Kok, MD
+31205129111
m.kok@nki.nl
Rianne Rolfes, MD
+31205129111
r.rolfes@nki.nl
F van den Berkmortel, MD
Zuyderland Medisch Centrum
Interventions
  • Drug: Adjuvant chemotherapy — adjuvant chemotherapy according to local/ national guidelines
  • Other: No adjuvant chemotherapy — no adjuvant chemotherapy
Study Locations (28 sites)
Zuyderland Medisch Centrum, Sittard-Geleen, Limburg 6162 BG Netherlands
Medical spectrum Twente, Enschede, Overijssel 7500 KA Netherlands
Noordwest Ziekenhuisgroep, Alkmaar, Netherlands
Flevoziekenhuis, Almere Stad, Netherlands
Meander Medisch Centrum, Amersfoort, Netherlands
Antoni van Leeuwenhoek, Amsterdam, 1066 CX Netherlands
Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, Netherlands
Rijnstate, Arnhem, Netherlands
Amphia ziekenhuis, Breda, Netherlands
Deventer Ziekenhuis, Deventer, Netherlands
Eligibility Criteria
Inclusion Criteria: * Female or male patients; * \>=18 years; * Written informed consent; * TNBC (defined as: invasive carcinoma; ER/PR expression 0-9%; Human Epidermal Growth Factor Receptor 2 \[HER2\] negative \[0, 1+ or 2+ on immunohistochemistry, without HER2 amplification on in-situ hybridization\]) on the diagnostic biopsy and the surgical specimen; * Pathological stage I TNBC (according to the TNM staging 8th edition): * pT1a/b/c (≤2 cm), confirmed by an invasive component of ≤2 cm on the surgical specimen (microinvasive disease \[pT1mi, ≤1 mm) is not allowed); * pN0, confirmed by absence of malignant cells in the sentinel lymph node or any other lymph node after surgery (isolated tumor cells \[N0(i+)\] are not allowed); * No evidence of nodal or distant metastases (cN0M0) on pre and/or postoperative imaging examinations (performed following local/national guidelines, but must include an 18F-fluorodeoxyglucose positron emission tomography/computed tomography \[18F-FDG-PET/CT, at least from skull base to upper legs\] or computed tomography \[CT\] of neck/chest/abdomen/pelvis \[CT only if 18F-FDG-PET/CT would not be available; 18F-FDG-PET/CT mandatory in the Netherlands\]); * sTIL score of ≥50% for patients ≥40 years at the time of TNBC diagnosis and ≥75% for patients \<40 years at the time of TNBC diagnosis on an H\&E FFPE tissue slide on the surgical specimen, according to International Immuno-Oncology Biomarker Working Group on Breast Cancer (formerly International TILs Working Group) guidelines, by local and central review * Has undergone curative breast surgery (breast-conserving surgery or mastectomy and surgical axillary staging \[including at least sentinel lymph node procedure\]); * Absence of recurrence between curative breast surgery and expression of patient preference; * Eligible for radiotherapy (if indicated). Exclusion Criteria: * Prior disease history of invasive and/or non-invasive breast cancer, or ongoing treatment for invasive and/or non-invasive breast cancer; * Multifocal, multicentric or bilateral breast cancer at the time of screening; * Administration of neoadjuvant systemic therapy; * Presence of lymphovascular invasion on the diagnostic biopsy and/or the surgical specimen; * Other invasive malignancy within 5 years prior to inclusion, with the exception of ade-quately treated non-melanoma skin cancer, localized cervical cancer, localized and Gleason ≤6 prostate cancer; * Uncontrolled severe illness or medical condition; * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the in the trial.

A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer

NCT06471205
Recruiting
Conditions Triple-negative Breast Cancer
Phase PHASE2
Enrollment 52
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-09
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 monoclonal antibody in patients with unresectable locally advanced or recurrent metastatic triple-negative breast cancer.

Design

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

Interventions / Regimen

  • Drug: BL-B01D1 — Administration by intravenous infusion on D1 and D8, or D1 for a cycle of 3 weeks.
  • Drug: PD-1 Monoclonal Antibody — Administration by intravenous infusion for a cycle of 3 weeks (Q3W).

Primary Outcomes

  • Objective Response Rate (ORR) (Up to approximately 24 months)
  • Recommended Phase II Dose (RP2D) (Up to approximately 24 months)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Recruiting
Start Date: 2024-08-02
Completion: 2028-06
Eligibility
Age: 18 Years – 75 Years
Sex: ALL
Volunteers: false
Enrollment: 52 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Principal Investigators:
  • Jiong Wu (PRINCIPAL_INVESTIGATOR) - Fudan University
  • Jian Zhang (PRINCIPAL_INVESTIGATOR) - Fudan University
Contact Information
Study Contact:
Sa Xiao, PHD
15013238943
xiaosa@baili-pharm.com
Jiong Wu
Fudan University Shanghai Cancer Center
Jiong Wu
Fudan University Shanghai Cancer Center
Interventions
  • Drug: BL-B01D1 — Administration by intravenous infusion on D1 and D8, or D1 for a cycle of 3 weeks.
  • Drug: PD-1 Monoclonal Antibody — Administration by intravenous infusion for a cycle of 3 weeks (Q3W).
Study Locations (1 sites)
Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality China
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily sign the informed consent and follow the requirements of the protocol; 2. Age: ≥18 years old and ≤75 years old; 3. Expected survival time ≥3 months; 4. ECOG 0 or 1; 5. Subjects with histologically and/or cytologically confirmed, inoperable locally advanced or recurrent or metastatic triple-negative breast cancer; 6. Patients should not have received previous systemic therapy for unresectable, locally advanced, recurrent, or metastatic triple-negative breast cancer; 7. A archived tumor tissue specimen or fresh tissue specimen of the primary or metastatic lesion within 2 years must be provided; 8. Must have at least one place in accordance with RECIST v1.1 define measurable lesions; 9. No blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before screening, and the organ function level must meet the requirements; 10. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0; 11. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, the serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment. Exclusion Criteria: 1. ADC drugs that have received topoisomerase I inhibitors as small molecule toxins; 2. Palliative radiotherapy within 2 weeks before the first dose; 3. Patients with checkpoint inhibitors prior to neoadjuvant/adjuvant chemotherapy; 4. Use of an immunomodulatory drug within 14 days before the first dose of study drug; 5. The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened; 6. QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia; 7. Active autoimmune and inflammatory diseases; 8. Receiving long-term systemic corticosteroid therapy, etc., before the first dose; 9. Other malignant tumors that progressed or required treatment within 5 years before the first dose; 10. Presence of: a) poorly controlled diabetes mellitus before starting study treatment; b) severe complications associated with diabetes mellitus; c) a glycated hemoglobin level of 8% or more; d) hypertension poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy; 11. Present grade ≥2 radiation pneumonitis according to the RTOG/EORTC definition; Patients with current ILD; 12. Complicated with pulmonary diseases leading to clinically severe respiratory impairment; 13. 6 months prior to screening needs treatment intervention unstable thrombotic events; 14. Patients with active central nervous system metastases; 15. Patients with massive or symptomatic effusions or poorly controlled effusions; 16. Allergic history to recombinant humanized antibody or human-mouse chimeric antibody or allergic to any excipients of the test drug; 17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation; 18. HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; 19. Serious infection within 4 weeks before the first dose of study drug; Signs of pulmonary infection or active pulmonary inflammation within 4 weeks; 20. Participated in another clinical trial within 4 weeks before the first dose; 21. Patients with superior vena cava syndrome should not be rehydrated; 22. Have a history of psychotropic substance abuse with an inability to quit or a history of severe neurological or psychiatric illness; 23. Imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels; 24. Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent; 25. Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent; 26. Subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose; 27. Other circumstances considered by the investigator to be inappropriate for participation in the trial.

Testing the Feasibility of a Virtual Application to Support Breast and Colorectal Cancer Survivors

NCT07312786
Recruiting
Conditions Breast Cancer Survivor, Colorectal Cance...
Phase NA
Enrollment 60
Locations 2 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-09
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

The goal of this study is to determine the feasibility of implementing a mobile health application for breast and colorectal cancer survivors following primary treatment. Developed in collaboration with Seamless MD, the intervention acts as an information hub, providing users with timely and evidence-based information related to follow-up care as well as health system/community-based resources and programs to meet their needs during this period of care. The goal of the intervention is to encourage open communication regarding survivorship expectations and provide survivors with appropriate information and support to meet their needs. This study will: 1. Test the feasibility of implementing the virtual intervention at two cancer centres in Atlantic Canada (Nova Scotia and New Brunswick) 2. Gather feedback regarding the intervention from cancer survivors and healthcare providers. Participants will have access to the intervention for a period of six months. Questionnaires will be distributed to participants through the intervention at baseline, 90 days, and 180 days to assess user experience. Semi-structured interviews will be conducted with select survivor participants and healthcare providers (oncology and primary care) to determine the feasibility and acceptability of this intervention.

Design

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

Interventions / Regimen

  • Behavioral: virtual self-management intervention — The intervention is a supportive information and self-management tool housed on the SeamlessMD mobile app, created in collaboration with the SeamlessMD development program and informed by foundational research. The application will be used as an information hub and self-management/navigation tool alongside usual care, to address the physical, psychosocial, and practical needs of breast and colorectal cancer survivors. Note that the intervention will not seek to change or impact a survivor's follow-up care plan, as decided upon by the participant and their care team.

Primary Outcomes

  • Recruitment (During enrollment)
  • Retention (Enrollment to day 180)
  • Usage of the Intervention (Baseline to day 180)
  • Survivor and Provider Acceptability and Experience (Interviews with survivor participants will be conducted after having access to the intervention for 180 days.)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-04-20
Completion: 2027-12
Eligibility
Age: 18 Years and older
Sex: ALL
Volunteers: false
Enrollment: 60 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Nova Scotia Health Authority
Collaborators: Canadian Cancer Society (CCS)
Contact Information
Study Contact:
Caroline Hovey
506 647 1462
cr344200@dal.ca
Saint John Regional Hospital
Caroline Hovey
506 647 1462
cr344200@dal.ca
Centre for Clinical Research QEII Health Sciences Centre
Interventions
  • Behavioral: virtual self-management intervention — The intervention is a supportive information and self-management tool housed on the SeamlessMD mobile app, created in collaboration with the SeamlessMD development program and informed by foundational research. The application will be used as an information hub and self-management/navigation tool alongside usual care, to address the physical, psychosocial, and practical needs of breast and colorectal cancer survivors. Note that the intervention will not seek to change or impact a survivor's follow-up care plan, as decided upon by the participant and their care team.
Study Locations (2 sites)
Saint John Regional Hospital, Saint John, New Brunswick Canada
Centre for Clinical Research QEII Health Sciences Centre, Halifax, Nova Scotia B3H 1V7 Canada
Eligibility Criteria
Inclusion Criteria: * Adults older than 18 years, capable of providing informed consent * Diagnosed with stage I-III breast or colorectal cancer, and have completed primary treatment for their cancer (surgery and/or adjuvant systemic or radiation therapy) 6 months - 5 years ago

Behavioral Pain Intervention for Older Cancer Patients

NCT07300995
Recruiting
Conditions Breast Cancer
Phase NA
Enrollment 168
Locations 1 sites
Compensation Not reported — ask the study team
Data Updated 2026-11-09
View Trial Details Official Listing I'm Interested
Study Details Design, interventions, and primary outcomes

About This Study

This randomized controlled trial examines a 1-session, telehealth pain coping skills training (PCST) protocol with five 15-minute maintenance calls (Brief PCST-Community) adapted for women with breast cancer in medically underserved areas. Pain, health-related quality of life, and self-efficacy for pain management will be assessed at baseline and 10 and 15 weeks later.

Design

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

Interventions / Regimen

  • Behavioral: Pain Coping Skills Training (PCST) — Behavioral pain intervention delivered via telehealth.

Primary Outcomes

  • Pain severity as measured by the Brief Pain Inventory (BPI) (Baseline, 10-week assessment, 15-week assessment)
  • Pain interference as measured by the Brief Pain Inventory (BPI) (Baseline, 10-week assessment, 15-week assessment)
  • Health Related Quality of Life (HR-QOL) as measured by the Patient Reported Outcomes Measurement Information System (PROMIS-29) - Physical Function (Baseline, 10-week assessment, 15-week assessment)
  • Health Related Quality of Life (HR-QOL) as measured by the Patient Reported Outcomes Measurement Information System (PROMIS-29) - Mental Health (Baseline, 10-week assessment, 15-week assessment)
Interested in this trial?
Contact the study team directly or view the official listing
View on ClinicalTrials.gov I'm Interested
Study Contact:
Study Information
Type: INTERVENTIONAL
Phase: NA
Status: Recruiting
Start Date: 2026-06-17
Completion: 2027-06-01
Eligibility
Age: 55 Years and older
Sex: FEMALE
Volunteers: false
Enrollment: 168 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Weill Medical College of Cornell University
Collaborators: National Institute on Aging (NIA), Duke University
Principal Investigators:
  • Cary Reid, MD, PhD (PRINCIPAL_INVESTIGATOR) - Weill Medical College of Cornell University
Contact Information
Study Contact:
Tamara Somers, PhD
919-416-3408
tamara.somers@duke.edu
Tamara Somers
Duke Cancer Network
Tamara Somers, PhD
Duke Cancer Network
Interventions
  • Behavioral: Pain Coping Skills Training (PCST) — Behavioral pain intervention delivered via telehealth.
Study Locations (1 sites)
Duke Cancer Network, Durham, North Carolina 27713 United States
Eligibility Criteria
Inclusion Criteria: * Receiving cancer care at a Duke Cancer Network (DCN) clinic * Stage I-IV breast cancer * Self-reported pain on at least 10 days in the last month and pain rating of worst pain of 4 or greater on a 0-10 scale in the last week * Biologically female * Greater than or equal to 55 years old * Ability to speak and read English * Hearing and vision that allows for successful completion of videoconferencing and phone session Exclusion Criteria: * Participation in the last 6 months in a pain coping skills training program