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Showing 20 of 30222 trials
Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
NCT02603341
Active, positions filled
Conditions Breast Cancer
Phase NA
Enrollment 1238
Locations 40 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Photon
  • Proton

Primary Outcomes

  • Effectiveness of proton therapy vs. photon therapy
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: 2016-04-06
Completion: 2036-11
Eligibility
Age: 21 Years
Sex: ALL
Volunteers: false
Enrollment: 1238 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Abramson Cancer Center at Penn Medicine
Collaborators: Patient-Centered Outcomes Research Institute
Principal Investigators:
  • Alexander Lin, MD (PRINCIPAL_INVESTIGATOR) - Abramson Cancer Center at Penn Medicine
  • Bonnie Ky, MD (PRINCIPAL_INVESTIGATOR) - Abramson Cancer Center at Penn Medicine
  • Shannon MacDonald, MD (STUDY_CHAIR) - Massachusetts General Hospital
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Photon
  • Proton
Study Locations (40 sites)
University of Alabama, Birmingham, Alabama 35233 United States
Mayo Clinic-Arizona, Phoenix, Arizona 85054 United States
UC San Diego, San Diego, California 92121 United States
Georgetown University Medical Center, Washington D.C., District of Columbia 20007 United States
University of Miami Sylvester Cancer Center at Coral Gables, Coral Gables, Florida 33146 United States
University of Miami Sylvester Cancer Center - Deerfield, Deerfield Beach, Florida 33442 United States
University of Florida Health, Gainesville, Florida 32610 United States
University of Florida Health Proton Therapy Institute, Jacksonville, Florida 32206 United States
University of Miami Sylvester Cancer Center, Miami, Florida 33136 United States
Miami Cancer Insititute, Miami, Florida 33176 United States
Eligibility Criteria
Inclusion Criteria: * Females or males diagnosed with pathologically (histologically) proven invasive mammary carcinoma (ductal, lobular or other) of the breast who have undergone either mastectomy or lumpectomy with any type of axillary surgery or axillary sampling. * For patients who have undergone lumpectomy, any type of mastectomy and any type of reconstruction (including no reconstruction) are allowed. * For patients who have undergone lumpectomy, there are no breast size limitations. * Patients with non-metastatic breast cancer are eligible. This includes American Joint Committee on Cancer (AJCC) 7th edition left- or right-sided breast cancer clinical or pathologic stage I, II, III or loco-regionally recurrent at time of diagnosis. For patients that receive neoadjuvant chemotherapy, AJCC 7th edition left- or right-sided breast cancer pathologic stage yp 0, I, II, III are eligible. * Bilateral breast cancer is permitted. Patients with bilateral breast cancer will be stratified as left-sided. * Must be proceeding with breast/chest wall and nodal radiation therapy including internal mammary node treatment. * Must have a pertinent history/physical examination within 90 days prior to registration. * Age ≥ 21 years * ECOG Performance Status 0 - 2 (asymptomatic to symptomatic but capable of self-care) within 90 days prior to randomization. * Confirmation that the patient's health insurance will pay for the treatment in this study (patients may still be responsible for some costs, such as co-pays and deductibles). If the patient's insurance will not cover a specific treatment in this study and the patient still wants to participate, confirmation that the patient would be responsible for paying for any treatment received. * Patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 180 days prior to registration as documented in the medical record. HIV testing is not required for eligibility for this protocol. * The patient must provide study-specific informed consent prior to study entry. Exclusion Criteria * Definitive clinical or radiologic evidence of metastatic disease, as documented by the treating institution. * Prior radiotherapy to the ipsilateral chest wall or ipsilateral breast or thorax. Individuals with prior radiotherapy in the contralateral breast or chest wall are eligible. * Any radiation therapy for the currently diagnosed breast cancer prior to randomization. * Dermatomyositis with a CPK level above normal or with an active skin rash or scleroderma. * Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
Neoadjuvant Response-guided Treatment of Slowly Proliferating Hormone Receptor Positive Tumors
NCT02592083
Active, positions filled
Conditions Early-Stage Breast Carcinoma, Hormone Re...
Phase PHASE2
Enrollment 10
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelin
  • Palbociclib

Primary Outcomes

  • Clinical and Radiological Response
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2015-10
Completion: 2029-02
Eligibility
Age: 41 Years
Sex: FEMALE
Volunteers: false
Enrollment: 10 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Thomas Hatschek
Principal Investigators:
  • Thomas Hatschek, Assoc. Prof. (STUDY_CHAIR) - Breast-sarcoma Unit, Dept. of Oncology, Karolinska University Hospital
  • Jonas Bergh, Professor (STUDY_DIRECTOR) - Dept. of Oncology-Pathology, Karolinska Institutet
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelin
  • Palbociclib
Study Locations (1 sites)
Department of Oncology, Karolinska University Hospital, Stockholm, 17176 Sweden
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent 2. Female patients with non-lobular breast cancer confirmed by histology 3. Tumor and blood samples available. Luminal A type confirmed by immunohistochemistry with ER and PR positive ≥50% and the proliferation marker Ki 67 \<20% and not HER2 amplified 4. Age older than 40 years 5. Primary breast cancer \>20mm without lymph node metastases 6. Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders 7. LVEF \>50% 8. ECOG performance status 0-1 Exclusion Criteria: 1. Metastases, including node metastases in the ipsilateral and/or contralateral thoracic region or in the mediastinum 2. Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix 3. Age ≤40 years 4. Lobular carcinoma 5. Patients in child-bearing age without adequate contraception 6. Pregnancy or lactation 7. Severe medical or psychiatric disorders where the study treatment or study procedures carry increased risk of deterioration of health status
Genomic Services Research Program
NCT02595957
Recruiting
Conditions Colon Cancer, Breast Cancer
Phase Not Applicable
Enrollment 5000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Health impacts of SF receipt
  • Adherence to medical recommendations
  • Family based positive predictive value
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: 2014-09-16
Completion: 2028-12-31
Eligibility
Age: 1 Month
Sex: ALL
Volunteers: false
Enrollment: 5000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: National Human Genome Research Institute (NHGRI)
Principal Investigators:
  • Leslie G Biesecker, M.D. (PRINCIPAL_INVESTIGATOR) - National Human Genome Research Institute (NHGRI)
Contact Information
Study Contact:
Julie C Sapp
(301) 435-2832
sappj@mail.nih.gov
Leslie G Biesecker, M.D.
(301) 402-2041
lesb@mail.nih.gov
Interventions
N/A
Study Locations (1 sites)
National Institutes of Health Clinical Center, Bethesda, Maryland 20892 United States
Eligibility Criteria
* ELIGIBILITY CRITERIA: We employ a referral form through SurveyMonkey to receive referrals from recruitment partners or self-referrals. This serves as an intake form and self-reported eligibility review. This form asks for contact information, key information about the prospective participant s SF, and subjective understanding of their result. If we conclude, based on a review of the SF and available personal and/or family history, that the pathogenicity of the SF is not at least likely pathogenic, that participant may be eligible for the survey, interview, and/or re-contact for future follow-up, but will not complete any other protocol procedures (such as cascade testing). If a participant is consented and information arises during the social and behavioral study procedures that lead study staff to believe the genetic result does not qualify as an SF, the participant will be considered a screen failure and will not continue with study procedures. We plan to offer enrollment in this protocol to English- or Spanish-speaking recipients of SF. We do not have trained staff who can conduct the interviews in languages other than English and Spanish. If a caregiver of a minor or adult who is unable to consent is enrolled as an index participant to complete the survey and interview on behalf of the SF recipient, they may also be eligible for cascade testing to relate presence of an SF-related phenotype in a family member with presence or absence of SF genotype. -We may enroll a child in this protocol if he/she is the only person in his/her family who has the SF, is symptomatic of the disease, or is in the age range to receive screening for the disease (e.g., Wilson disease and familial hypercholesterolemia have childhood onset). We will not enroll neonates (less than one month old). * We may enroll adults who are unable to consent (i.e., an individual who is impaired at the time of consent) in this protocol if he/she is the only person in his/her family who has the SF, is symptomatic of the disease, or is in the age range to receive screening for the disease. * We may enroll women who are pregnant in this protocol and women who become pregnant during the study can continue their participation. We will not perform prenatal genetic testing. * NIH staff members are not prohibited from enrollment if they meet the study s eligibility criteria. The study team will make every effort to protect the confidentiality of the NIH staff member s health information, to minimize any pressure on or discomfort of the NIH staff member and provide a copy of the NIH Frequently Asked Questions (FAQs) for Staff Who are Considering Participation in NIH Research , before consent is obtained.
Creatine for Depressed Male and Female Methamphetamine Users
NCT02568878
Recruiting
Conditions Depression, Anxiety, Methamphetamine Dep...
Phase PHASE3
Enrollment 29
Locations 1 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Creatine monohydrate

Primary Outcomes

  • Hamilton Depression Rating Scale (HAMD) Scores
  • Hamilton Anxiety Rating Scale (HAMA) Scores
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2015-11
Completion: 2017-05
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 29 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Montana State University
Principal Investigators:
  • Tracy Hellem, PhD (PRINCIPAL_INVESTIGATOR) - Montana State University
Contact Information
Study Contact:
Tracy Hellem, PhD
406 243 2110
tracy.hellem1@montana.edu
Interventions
  • Creatine monohydrate
Study Locations (1 sites)
Montana State University College of Nursing (Missoula campus), Missoula, Montana 59812 United States
Eligibility Criteria
Inclusion Criteria: * Current primary diagnosis of methamphetamine dependence or abuse, with methamphetamine preferred drug of abuse * Current diagnosis of major depressive disorder (primary or substance-induced) * Current diagnosis of an anxiety disorder (primary or substance-induced) * Current Hamilton Depression Rating scale score \> or = to 16 * Current Hamilton Anxiety Scale score \> = to 18 * If taking a psychotropic medication for depressed or anxious mood, regimen must be stable for \> = to 4 weeks prior to creatine treatment initiation Exclusion Criteria: * Persons unable to provide adequate informed consent * Persons who are at clinically significant suicidal or homicidal risk * Primary substance-related diagnosis other than methamphetamine dependence or abuse * Positive pregnancy test (females only) * History of renal disease * Clinically significant medical or neurological illness identified by history, physical exam and laboratory testing * History of hypersensitivity reaction to creatine
Muscle Loss and Fatigue as a Consequence of Radiotherapy
NCT02567669
Active, positions filled
Conditions Breast Cancer, Fatigue, Sarcopenia
Phase Not Applicable
Enrollment 20
Locations 0 sites
Compensation Compensation varies
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • standard postoperative radiotherapy for breast cancer

Primary Outcomes

  • Changes in self-reported fatigue using the validated questionnaire "Brief Fatigue Inventory"
  • Changes in muscle area outside the radiation treatment area determined on cross sectional anatomy from CT scan images
  • Correlation between muscle area and fatigue
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: OBSERVATIONAL
Phase: Not Applicable
Status: Active, positions filled
Start Date: 2016-01
Completion: 2026-12
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 20 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Essentia Health
Principal Investigators:
  • Ken Dornfeld, MD PhD (PRINCIPAL_INVESTIGATOR) - Essentia Health
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • standard postoperative radiotherapy for breast cancer
Eligibility Criteria
Inclusion Criteria: 1. Women Age ≥ 18 years 2. Non-metastatic breast cancer for which post-operative radiation treatment has been recommended as standard of care 3. Able to provide informed consent 4. Able to complete the Brief Fatigue Inventory questionnaire - Exclusion Criteria: 1. Pregnant 2. Inability to meet eligibility requirements -
Riociguat in Children With Pulmonary Arterial Hypertension (PAH)
NCT02562235
Active, positions filled
Conditions Hypertension, Pulmonary
Phase PHASE3
Enrollment 24
Locations 16 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Riociguat (Adempas, BAY63-2521)

Primary Outcomes

  • Number of Participants With Any Treatment-emergent Adverse Events
  • Change in Heart Rate From Baseline
  • Change in Blood Pressure From Baseline
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: 2015-10-29
Completion: 2027-08-03
Eligibility
Age: 6 Years
Sex: ALL
Volunteers: false
Enrollment: 24 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Bayer
Collaborators: Merck Sharp & Dohme LLC
Principal Investigators:
  • Bayer Study Director (STUDY_DIRECTOR) - Bayer
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Riociguat (Adempas, BAY63-2521)
Study Locations (16 sites)
Clínica Imbanaco S.A.S, Cali, Valle del Cauca Department 760042 Colombia
Universitätsklinikum Heidelberg, Heidelberg, Baden-Wurttemberg 69115 Germany
Universitätsklinikum Ulm, Ulm, Baden-Wurttemberg 89075 Germany
Deutsches Herzzentrum der Charité (DHZC), Berlin, 13353 Germany
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ, Szeged, Csongrád-Csanád 6720 Hungary
Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet, Budapest, 1096 Hungary
Azienda Ospedale-Università di Padova - UOC Cardiologia Pediatrica, Padova, Veneto 35128 Italy
Aichi Children's Health and Medical Center, Ōbu, Aichi-ken 474-8710 Japan
The University of Osaka Hospital, Suita, Osaka 565-0871 Japan
National Cerebral and Cardiovascular Center, Suita, Osaka 565-8565 Japan
Eligibility Criteria
Inclusion Criteria: * Children from 6 years to less than 18 years of age with pulmonary arterial hypertension (PAH) * Diagnosed with PAH : * Idiopathic (IPAH) * Hereditable (HPAH) * PAH associated with (APAH) * Connective tissue disease * Congenital heart disease with shunt closure more than 6 months ago (no open shunts, confirmed by RHC no less than 4 months after surgery) Regardless of the type of PAH, the following findings are not exclusionary: \--- Patent foramen ovale (PFO) and asymptomatic, isolated, ostium secundum atrial septal defect (OS-ASD) ≤ 1 cm (both confirmed by echocardiogram) and not associated with hemodynamic alterations indicative of significant shunt, e.g. Qp/Qs ratio less \<1.5:1 are not exclusionary * PAH diagnosed by right heart catheterization (RHC) at any time prior to enrolment (for patients with closed shunts - RHC no less than 4 months after surgery) * PAH confirmed by a RHC at any time prior to start of study, with mean pulmonary artery pressure (PAPmean) ≥25 mmHg at rest, pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) ≤15 mmHg, and pulmonary vascular resistance (PVR) \>240 dyn•sec•cm\^-5 (i.e., ≥3.0 wood units•m\^2) * Patients must be on standard of care PAH medications, allowing Endothelin Receptor Antagonists (ERA) and/or Prostacyclin Analogues (PCA), for at least 12 weeks prior to baseline visit. Two groups of patients will be included: * Prevalent: Patients currently on PAH medication (allowing ERA and/or PCA) who need additional treatment (discretion of the investigator) * Incident: Treatment naïve patients initiated on PAH medication (allowing ERA and /or PCA) and then riociguat added once patients are stable on standard of care * WHO functional class I-III * Adolescent females of childbearing potential can only be included in the study if a pregnancy test is negative. Adolescent females of childbearing potential must agree to receive sexual counseling and use effective contraception as applicable. 'Effective contraception' is defined as progestogen-only hormonal contraception associated with inhibition of ovulation (implant), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), or any combination of adequate methods of birth control (e.g. condoms with hormonal contraception). Agreement to use contraception is required from the signing of the informed consent form up until 4 weeks after the last study drug administration. * Young men must agree to use adequate contraception when sexually active. * Written inform consent provided and if applicable child assent provided Exclusion Criteria: * Concomitant use of the following medications: phosphodiesterase (PDE) 5 inhibitors (such as sildenafil, tadalafil, vardenafil) and non-specific phosphodiesterase (PDE) inhibitors (theophylline, dipyridamole), nitrates or NO donors (such as amyl nitrite) in any form \-- Pretreatment with NO donors (e.g. nitrates) within the last 2-weeks before visit 1. The use of any drug including NO acutely for testing during catheterization is not an exclusion criterion. * Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization or any history of bronchial artery embolization or massive hemoptysis within 3 months prior to screening * Systolic blood pressure (SBP) more than 5 mmHg lower than the age-, sex- and height-adapted level of the 50th SBP percentile (NHBPEP, 2004) * History of left-sided heart disease, including valvular disease or heart failure * Pulmonary hypertension related to conditions other than specified in the inclusion criteria * WHO functional class IV * Pulmonary veno-occlusive disease * Screening aspartate transaminase (AST) and/ or alanine transaminase (ALT) more than 3 times the upper limit of normal (ULN) * Severe restrictive lung disease * Severe congenital abnormalities of the lung, thorax, and diaphragm * Clinically relevant hepatic dysfunction (especially Child Pugh C) * Renal insufficiency (estimated glomerular filtration rate \<30 mL/min/1.73m\^2 e.g. calculated based on Schwartz formula) * PH associated with idiopathic interstitial pneumonia (PH-IIP)
Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer
NCT02547987
Active, positions filled
Conditions Breast Cancer
Phase PHASE2
Enrollment 25
Locations 3 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Docetaxel
  • Carboplatin

Primary Outcomes

  • Pathologic Complete Response
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2015-11-01
Completion: 2025-09
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 25 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Mothaffar Rimawi
Principal Investigators:
  • Mothaffar Rimawi, MD (PRINCIPAL_INVESTIGATOR) - Baylor College of Medicine
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Docetaxel
  • Carboplatin
Study Locations (3 sites)
TriHealth Hatton Research, Cincinnati, Ohio 45242 United States
Lester & Sue Smith Breast Center at Baylor College of Medicine, Houston, Texas 77030 United States
Harris Health System Smith Clinic, Houston, Texas 77054 United States
Eligibility Criteria
Inclusion Criteria: * All patients must be 18 years of age or older. * All patients must be diagnosed with invasive breast cancer. * Breast cancer must be ER-negative, and HER-2 negative according to CAP/ASCO biomarkers testing guidelines. Tumors may be PgR positive with an Allred score of less than 5. * Primary breast tumor size at least 2 cm in one dimension by clinical or radiographic exam. Patients who have multicentric breast cancer are eligible if each lesion is estrogen receptor negative and HER2-negative. In that case, one lesion needs to be identified as the index lesion to be followed for clinical response. The index lesion must also be the lesion from which core biopsies are obtained. * Patients with inflammatory breast cancer are eligible if they meet both of the following criteria: 1. Patient has an underlying, clinically palpable breast mass of at least 2cm, AND 2. a corresponding lesion is visualized on mammogram or ultrasound * Normal bone marrow and organ function as defined below: * Leukocytes \> 3,000/mcL * Absolute neutrophil count \> 1,200/mcl * Platelets \> 100,000/mcl * Serum bilirubin ≤ institutional 1.5 times upper limit of normal (ULN) * Aspartate aminotransferase/alanine aminotransferase ≤ 2.5 times ULN * Creatinine ≤ 1.5 ULN * Women of childbearing potential (defined as women under the age of 55 with intact ovaries and uterus) must agree to use adequate contraception prior to study entry and for the duration of study participation. They must also have a negative urine pregnancy test within 7 days of starting treatment. * Ability to understand and willingness to sign an IRB approved written informed consent document and follow study procedures including willingness to undergo study biopsies. Exclusion Criteria: * Any prior systemic therapy for breast cancer within 5 years. * A history of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix. * Patients with known bilateral invasive breast cancer. Patients with contralateral in situ breast carcinoma are eligible. * Inflammatory breast cancer. * Patients with confirmed stage IV disease. * Currently receiving any other investigational agents. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to docetaxel or carboplatin. * Known to be seropositive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV). * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * If the patient is otherwise not deemed a good study candidate by sole discretion of the principal investigator. * Patient is pregnant or breastfeeding.
The Lake Nona Life Project
NCT02533804
Recruiting
Conditions Health Behavior, Quality of Life, Aging
Phase Not Applicable
Enrollment 10000
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Quality of Life over 10 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: 2014-12-31
Completion: 2025-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 10000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Central Florida
Collaborators: Lake Nona Institute, DataStat, Inc., Mytrus, Inc.
Principal Investigators:
  • Patricia Robinson (PRINCIPAL_INVESTIGATOR) - Center for CREATION Health Research
Contact Information
Study Contact:
Ashley Kohrt
ashley.kohrt@flhosp.org
Jasmine Jones
jasmine.jones@flhosp.org
Interventions
N/A
Study Locations (1 sites)
Lake Nona Institute, Orlando, Florida 32827 United States
Eligibility Criteria
Inclusion Criteria: * 18 years or older * Live and/or work in the Lake Nona Community (proper) * Able to provide informed consent * Able to speak and read English Exclusion Criteria: * Unable to speak or communicate in English * Living outside of the LNLP study map * Cognitive impairment that would not allow survey completion * Unable to speak and read English
Neoadjuvant Endocrine Therapy Versus Chemotherapy in Premenopausal Patients With ER+ & HER2- Breast Cancer
NCT02535221
Recruiting
Conditions Breast Cancer
Phase PHASE3
Enrollment 234
Locations 1 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Goserelin+TAM+AI
  • Epirubicin+CTX+5-Fu

Primary Outcomes

  • ultrasound response rate
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE3
Status: Recruiting
Start Date: 2015-07-29
Completion: 2026-12-31
Eligibility
Age: 35 Years
Sex: FEMALE
Volunteers: false
Enrollment: 234 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Peking University
Principal Investigators:
  • Tao Ouyang, MD (STUDY_CHAIR) - Peking University Cancer Hospital & Institute
Contact Information
Study Contact:
Tao Ouyang, MD
ouyanghongtao@263.net
Interventions
  • Goserelin+TAM+AI
  • Epirubicin+CTX+5-Fu
Study Locations (1 sites)
Beijing Cancer Hospital Breast Center, Beijing, China
Eligibility Criteria
Inclusion Criteria: * 35 years old \<age≤55 years old, in premenopausal status(with the judgement by researchers when the patients are recruited) Histologically confirmed primary invasive breast cancer * Stage: T2N0M0(cT\>2cm, SLNB negative), hard to proceed the breast conserving surgery(not feasible or may affect the appearance of breast) * Histologically confirmed HR+ (ER or PR positive, and \>50% cell in IHC) HER2 negative breast cancer by pathological evaluation * No other previous treatment for primary breast cancer * Without other tumor or unstable complication or uncontrolled infection * No contradiction for the third generation AIs, LHRHa, chemotherapy * Attend the study voluntarily, sign the informed consent. Exclusion Criteria: * Metastasis disease by pathological or radiological diagnosis * the history of other tumor * contradiction for the third generation AIs, LHRHa, chemotherapy * Contradiction for adjuvant chemotherapy: serious cardiology or cerebral vessel disease, liver or kidney disfunction, blood system disease, the other situation or complication that are not suitable or cannot adaptable for chemotherapy * Contradiction for proceeding surgery: contradiction for anesthesia, large lesion,T4, lymph node positive * other situation not suitable for the research: psychological disease, mental disorder, social problem, geographic problem * have been attendance in other anti-tumor treatment or other clinical trials 8) reject to attend the study
Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer
NCT02488967
Active, positions filled
Conditions Breast Adenocarcinoma, Estrogen Receptor...
Phase PHASE3
Enrollment 782
Locations 1296 sites
Compensation Phase 3: Typically $200-$1,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Carboplatin
  • Cyclophosphamide
  • Doxorubicin Hydrochloride
  • Laboratory Biomarker Analysis
  • Paclitaxel

Primary Outcomes

  • IDFS
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: 2015-07-26
Completion: 2026-10-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 782 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: NRG Oncology
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Vicente Valero (PRINCIPAL_INVESTIGATOR) - NRG Oncology
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Carboplatin
  • Cyclophosphamide
  • Doxorubicin Hydrochloride
  • Laboratory Biomarker Analysis
  • Paclitaxel
Study Locations (1296 sites)
Southern Cancer Center PC-Mobile, Mobile, Alabama 36607 United States
Southern Cancer Center PC-Providence, Mobile, Alabama 36608 United States
Southern Cancer Center PC-Springhill, Mobile, Alabama 36608 United States
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 Regional Hospital, Anchorage, Alaska 99508 United States
Alaska Women's Cancer Care, Anchorage, Alaska 99508 United States
Anchorage Oncology Centre, Anchorage, Alaska 99508 United States
Eligibility Criteria
Inclusion Criteria: * The patient must have signed and dated an institutional review board (IRB)-approved consent form that conforms to federal and institutional guidelines * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination * All of the following staging criteria (according to the 7th edition of the American Joint Committee on Cancer \[AJCC\] Cancer Staging Manual) must be met: * By pathologic evaluation, primary tumor must be pT1-3 * By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b * If pN0, pathological tumor must be greater than or equal to 3.0 cm * The tumor must have been determined to be human epidermal growth factor receptor 2 (HER2)-negative as follows: * Immunohistochemistry (IHC) 0-1+; or * IHC 2+ and in situ hybridization (ISH) non-amplified with a ratio of HER2 to centromere enumerator probe 17 (CEP17) less than 2.0, and if reported, average HER2 gene copy number less than 4 signals/cells; or * ISH non-amplified with a ratio of HER2 to CEP17 less than 2.0, and if reported, average HER2 gene copy number less than 4 signals/cells * The tumor must have estrogen receptor (ER)-and progesterone receptor (PgR)-status assessed using current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines; patients are eligible if the tumor staining meets one of the following criteria: * ER-negative and PgR-negative by ASCO/CAP guidelines, OR * ER or PgR stains are positive in 1-9% of cells and neither is positive in greater than or equal to 10% of cells. * The patient must have undergone either a mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy * For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist; if pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ \[LCIS\] are eligible without additional resection) * For patients who undergo mastectomy, the margins must be free of residual gross tumor; (patients with microscopic positive margins are eligible as long as post-mastectomy radiation therapy \[RT\] of the chest wall will be administered) * The patient must have completed one of the procedures for evaluation of pathologic nodal status listed below. * Sentinel lymphadenectomy alone: * If pathologic nodal staging based on sentinel lymphadenectomy is pN0 or pN1b; * If pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1a and the patient has undergone breast conserving surgery (with planned breast radiotherapy), the primary tumor must be T1 or T2 by pathologic evaluation and the nodal involvement must be limited to 1 or 2 positive nodes * Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; or * Axillary lymphadenectomy with or without SN isolation procedure * The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 60 days * Absolute neutrophil count (ANC) must be greater than or equal to1200/mm\^3 * Platelet count must be greater than or equal 100,000/mm\^3 * Hemoglobin must be greater than or equal to 10 g/dL * Adequate hepatic function must be met based on the results of the most recent postoperative tests performed with 6 weeks prior to randomization. * Total bilirubin must be less than or equal to upper limit of normal (ULN) for the laboratory (lab) unless the patient has a bilirubin elevation greater than ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin * Alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab * Aspartate aminotransferase (AST) must be less than or equal to 1.5 x ULN for the lab * Note: If alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be less than or equal to 1.5 x ULN; if both were performed, the AST must be less than or equal to 1.5 x ULN. * Patients with AST or alkaline phosphatase greater than ULN are eligible for inclusion in the study if liver imaging (computed tomography \[CT\], magnetic resonance imaging \[MRI\], positron emission tomography \[PET\]-CT, or PET scan) performed within 90 days prior to randomization does not demonstrate metastatic disease and the requirements above are met * Patients with alkaline phosphatase that is greater than ULN but less than or equal to 2.5 x ULN or unexplained bone pain are eligible for inclusion in the study if a bone scan, PET-CT scan, or PET scan performed within 90 days prior to randomization does not demonstrate metastatic disease * Adequate renal function determined within 6 weeks prior to randomization defined as the most recent serum creatinine less than or equal to ULN or measured or calculated creatinine clearance greater than 60 mL/min * Left ventricular ejection fraction (LVEF) assessment must be performed within 90 days prior to randomization; (LVEF assessment performed by 2-dimensional \[D\] echocardiogram is preferred; however, multi gated acquisition \[MUGA\] scan may be substituted based on institutional preferences;) the LVEF must be greater than or equal to 50% regardless of the cardiac imaging facility's lower limit of normal. Exclusion Criteria: * T4 tumors including inflammatory breast cancer * Definitive clinical or radiologic evidence of metastatic disease; required imaging studies must have been performed within 90 days prior to randomization * Synchronous or previous contralateral invasive breast cancer; (patients with synchronous and/or previous contralateral DCIS or LCIS are eligible) * Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS; (patients with synchronous or previous ipsilateral LCIS are eligible) * History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization * Previous therapy with anthracyclines or taxanes for any malignancy * Chemotherapy administered for the currently diagnosed breast cancer prior to randomization * Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization * Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to: * Active cardiac disease * Angina pectoris that requires the current use of anti-anginal medication; * Ventricular arrhythmias except for benign premature ventricular contractions; * Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; * Conduction abnormality requiring a pacemaker; * Valvular disease with documented compromise in cardiac function; or * Symptomatic pericarditis * History of cardiac disease * Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricle (LV) function; * History of documented congestive heart failure (CHF); or * Documented cardiomyopathy * Uncontrolled hypertension defined as sustained systolic blood pressure (BP) greater than 150 mmHg or diastolic BP greater than 90 mmHg; (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressu
Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation in Early Breast Cancer
NCT02474641
Active, positions filled
Conditions Early-Stage Breast Carcinoma
Phase NA
Enrollment 2324
Locations 88 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Standard Radiation
  • Hypofractionation with SIB

Primary Outcomes

  • Progression free survival
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: 2015-06-16
Completion: 2028-03-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 2324 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: University Hospital Schleswig-Holstein
Collaborators: University of Luebeck
Principal Investigators:
  • Jürgen Dunst, MD (STUDY_CHAIR) - University Medical Center Schleswig-Holstein (UKSH)
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Standard Radiation
  • Hypofractionation with SIB
Study Locations (88 sites)
Gesundheitszentrum St.Marien Gmbh und Klinik für Strahlentherapie, Amberg, 92224 Germany
Medizinisches Versorgungszentrum Aue, Aue, 08280 Germany
Helios Kliniken Bad Saarow Klinik für Radioonkologie, Bad Saarow, 15526 Germany
HELIOS Klinikum Bad Saarow, Bad Saarow, 15526 Germany
Strahlentherapie Klinikum Bayreuth, Bayreuth, 95445 Germany
Medizinisches Versorgungs Zentrum Diagnostisch Therapeutisches Zentrum am Frankfurter Tor, Berlin, 10243 Germany
Strahlentherapie in Moabit /Praxis für Strahlentherapie, Berlin, 10559 Germany
Praxis für Radioonkologie und Strahlentherapie Berlin Südwest, Berlin, 12157 Germany
Ambulantes Gesundheitszentrum der Dr. med Maria Sternemann Charte -Universitätsmedizin Berlin, Berlin, 12200 Germany
Vivantes-Klinikum Berlin-Neukölln, Berlin, 12351 Germany
Eligibility Criteria
Inclusion Criteria: * Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins independently of further risk factors (positive or high-risk negative lymph node status, estrogen- or progesterone receptor status, Her-2/neu status uPA/PAI-1 criteria) and postoperative systemic therapy (chemotherapy, endocrine, antibody or bisphosphonate therapy were permitted when indicated) * Indication to adjuvant radiotherapy including boost radiotherapy * Clearly identified primary tumor region preferably by radiopaque clips * Primary wound healing after breast conserving therapy without signs of infection * Age ≥ 18 years * ECOG ≤ 2 Performance Status * Written informed consent * Compliance regarding treatment appointments and toxicity * Linguistic and cognitive ability to understand the questionnaires Exclusion Criteria: * Patients operated by mastectomy * No indication for boost radiation (e.g. status after IORT) * double sided breast cancer * Resection margins positive for disease or insufficient identification of the boost volume * Indication for radiotherapy of the regional lymph nodes * History of prior breast or thoracic radiotherapy * Extended postoperative seroma at the beginning of radiotherapy * Previously administered radiotherapy not allowing the required dose * Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception * treatment history of other cancer or participation in another clinical trial testing radiotherapy or drugs within 4 weeks of the start of treatment. * Patients with serious, uncontrolled, physical or cerebrovascular disorders(e.g. myocardial infarction within the last 12 months) or neurologiy or psychiatric disorders thought to adversly affect treatment compliance
Phase II Breast Ca Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab or Bevacizumab
NCT02436993
Active, positions filled
Conditions Breast Carcinoma
Phase PHASE2
Enrollment 120
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Carboplatin
  • Paclitaxel
  • Bevacizumab
  • Trastuzumab
  • Pertuzumab

Primary Outcomes

  • 2-year progression free survival in patients treated with weekly carboplatin and paclitaxel combined with either trastuzumab and pertuzumab for HER2-positive patients or bevacizumab for HER2-negative patients in the neoadjuvant setting
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2015-04
Completion: 2036-12
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: false
Enrollment: 120 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: University of California, Irvine
Principal Investigators:
  • Rita Mehta, MD (PRINCIPAL_INVESTIGATOR) - University of California, Irvine
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Carboplatin
  • Paclitaxel
  • Bevacizumab
  • Trastuzumab
  • Pertuzumab
Study Locations (1 sites)
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California 92868 United States
Eligibility Criteria
Inclusion Criteria: 1. Histologically proven unilateral or bilateral primary breast carcinoma. (In case of bilateral cancer, the investigator has to decide prospectively which side will be evaluated for the primary endpoint.) 2. Tumor size is clinically at least 1 cm in greatest diameter (palpable or by imaging) and/or with involved lymph node. In case of inflammatory disease, the extent of inflammation may be the measurable lesion. 3. Documentation of inflammatory breast cancer 4. Woman age \> or = 18 5. Performance status of 0-2 by Eastern Cooperative Oncology Group (ECOG) criteria 6. Known HER2 status 7. Normal cardiac function must be documented within 90 days prior to registration either via an ECHO or MUGA or per physician's review of symptoms and medical history. If an ECHO is performed as standard of care, the ejection fraction must be above the normal limit of the institution.. If not available in the medical chart, the ECHOs or MUGAs are not required to be repeated for research purposes. a. Date of Echo or multigated acquisition (MUGA) (within 90 days) if performed 8. Staging work-up prior to registration 1. Date of physical examination (within 90 days) 2. Date of bilateral mammogram (within 90 days) 3. Date of breast ultrasound (within 90 days) 4. Date of MRI breast (within 30 days) 5. Chest X-ray or CT- Chest or CT/PET Scan that includes the Chest may be done at physician's discretion (within 90 days). If not available in the medical chart, the Chest X-ray or CT- Chest or CT/PET Scan that includes the Chest is not required to be repeated for research purposes. 6. Other tests as clinically indicated 9. Laboratory requirements: 1. Hematology: * Absolute Neutrophil Count (ANC) ≥ 1,500/μl * Platelets ≥ 100,000/μl 2. Hepatic Function * Total Bilirubin \<1x upper limit of normal (ULN) * aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2x ULN 3. Renal Function \- Creatinine \<1.5x ULN 4. Proteinuria \- Random urine total protein \<100mg/dL. Urine Protein Creatinine (UPC) ratio \<2g 5. Negative pregnancy test for women of childbearing potential within 14 days prior to registration. 10. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines. Exclusion Criteria: 11. Evidence of distant metastasis. If radiographic suspicion of distant metastatic site, a negative biopsy must be available in the medical record. If not available in the medical record, the subject may be included and a confirmatory biopsy is not required to be performed for research purposes. 12. Known or suspected congestive heart failure, angina pectoris requiring antianginal medication, or other clinically significant cardiac condition. 13. Pregnant or nursing women may not participate due to the possibility of harm to fetus or nursing infants from this treatment regimen. Women of childbearing potential may not participate unless they have agreed to use an adequate contraceptive method throughout study treatment and for one month after completion of treatment. 14. Male patients 15. Pre-existing peripheral neuropathy of severity grade ≥ 2 (limiting instrumental activities of daily living). 16. Incomplete wound healing. 17. Active and significant bleeding 18. Known allergy, hypersensitivity or prior infusion reaction to one or more of the therapies incorporated into this treatment protocol. 19. Bone marrow depression or hematologic parameters in the range that would increase the risk for severe bleeding.
Role of Sympathetic Activity and Splanchnic Capacitance in Hypertension
NCT02425566
Active, positions filled
Conditions Hypertension
Phase PHASE1
Enrollment 12
Locations 1 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Trimethaphan
  • Nitroglycerin

Primary Outcomes

  • Splanchnic venous capacitance
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: 2015-04
Completion: 2026-08
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: true
Enrollment: 12 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Vanderbilt University
Principal Investigators:
  • Italo Biaggioni, MD (PRINCIPAL_INVESTIGATOR) - Vanderbilt University
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Trimethaphan
  • Nitroglycerin
Study Locations (1 sites)
Autonomic Dysfunction Center, Nashville, Tennessee 37232 United States
Eligibility Criteria
Inclusion Criteria: * Lean and obese, male and female subjects of all races between 18 and 65 years of age. * Normotensive and hypertensive subjects will be enrolled. Hypertension will be defined as a systolic BP ≥140 mm Hg and/or a diastolic BP ≥ 90 mm Hg, taken in the seated position in at least 2 separate occasions. All subjects will be otherwise normal volunteers. * Subjects able and willing to provide informed consent. Exclusion Criteria: * Pregnancy. * Subjects with morbid obesity (BMI \> 40 kg/m2). * Subjects with any chronic disease (other than hypertension) including diabetes, cardiovascular disease, history of smoking, or if they take any medication that have known effects autonomic functions, or other factors which in the investigator's opinion would prevent the subject from completing the protocol including clinically significant abnormalities in clinical, mental or laboratory testing. * Current smokers or history of heavy smoking (\>2 packs/day) * Lean normotensive subjects will be excluded if they have a strong family history of hypertension (both parents treated or diagnosed), diagnosis of sleep apnea or a high score in the Berlin questionnaire for sleep apnea, or if they are highly trained athletes.
Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy
NCT02411656
Active, positions filled
Conditions Edema, Erythema, Estrogen Receptor Negat...
Phase PHASE2
Enrollment 71
Locations 1 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Laboratory Biomarker Analysis
  • Pembrolizumab

Primary Outcomes

  • To Assess the Efficacy of Pembrolizumab as a Single Agent in Patients With Metastatic IBC or Non-IBC TNBC
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2015-06-11
Completion: 2028-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 71 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Bora Lim, MD (PRINCIPAL_INVESTIGATOR) - M.D. Anderson Cancer Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Laboratory Biomarker Analysis
  • Pembrolizumab
Study Locations (1 sites)
M D Anderson Cancer Center, Houston, Texas 77030 United States
Eligibility Criteria
Inclusion Criteria: * Is willing and able to provide written informed consent for the trial * Is a female or male and \>/= 18 years of age * Has histological confirmation of HER2 normal breast carcinoma with a clinical diagnosis of IBC based on presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d'orange), with or without an underlying palpable mass involving the majority of the skin of the breast; pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis of inflammatory breast cancer regardless estrogen receptor (ER)/progesterone receptor (PR) status; OR has histological confirmation of triple negative breast carcinoma (HER2 normal, ER/PR \< 10%) without clinical diagnosis of IBC * Has stage IV or recurrent disease that has been treated * Has clinical response or stable disease for minimum of two months (three cycles of every three week chemotherapy or 8 weeks of weekly regimen, etc.) after receiving any prior chemotherapy for metastatic/recurrent disease; a minimum of two cycles (6-8 weeks) of chemotherapy is required to determine clinical response. Per RECIST criteria 1.1, Clinical response for measurable disease is defined as complete response (CR) or partial response (PR); for non-measurable disease only (i.e. bone metastasis, ascites, pleural effusion, and pathological lymph nodes \>/= 10 to \<15 mm short axis) is defined as persistence of one or more non-target lesion(s) and no increase in overall tumor burden. * Is HER2 normal, defined as HER2 0 or 1+ by IHC and negative by FISH if performed; or HER2 is 2+ by IHC and negative by FISH; or HER2 negative by FISH if IHC is not performed. * Has a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) performance scale * Has adequate organ function as determined by the following laboratory values: ANC \>/= 1000 /mcL, Platelets \>/=100,000 /mcL, Hgb \>/= 9 g/dL, creatinine levels \< 1.5 x ULN, Total bilirubin \</= 1.5 x ULN, ALT and AST \</= 2.5 x ULN or \</=5 x ULN for participants with liver metastases. * Participants of childbearing potential should be willing to use effective methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through at least 4 months after the last dose of study drug. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year. Effective methods of birth control include 1). Use of hormonal birth control methods: pills, shots/injections, implants (placed under the skin by a health care provider), or patches (placed on the skin); 2).Intrauterine devices (IUDs); 3).Using 2 barrier methods (each partner must use 1 barrier method) with a spermicide. Males must use the male condom (latex or other synthetic material) with spermicide. Females must choose either a Diaphragm with spermicide, or Cervical cap with spermicide, or a sponge (spermicide is already in the contraceptive sponge). * Has negative serum or urine pregnancy test for participants of childbearing potential Exclusion Criteria: * Is currently participating in a study of an investigational anti-cancer agent * Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy * Has not recovered from adverse events due to prior therapies, i.e. monoclonal antibody, chemotherapy, targeted small molecule therapy, radiation therapy, or surgery. (Note: Participants with ≤ grade 2 neuropathy, alopecia and general disorders and administration site conditions \[per Common Terminology Criteria for Adverse Events (CTCAE version 4.0) are an exception to this criterion and may qualify for the study) * Has a known malignancy (other than breast cancer) except basal cell carcinoma or squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis; participants with previously treated brain metastases may participate if they are stable, and have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment * Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents; participants with vitiligo or resolved childhood asthma/atopy would be an exception to this rule. Participants that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Participants with hypothyroidism stable on hormone replacement or Sjogren's syndrome will not be excluded from the study. * Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis * Has an active infection requiring systemic therapy * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial * Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). * Has a known history of human immunodeficiency virus (HIV) * Has a known active hepatitis B or hepatitis C * Have received a live vaccine within 30 days prior to the first dose of trial treatment * Is receiving concurrent anti-cancer therapy for metastatic disease
Malignant Pleural Disease Treated With Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin
NCT02414269
Active, positions filled
Conditions Malignant Pleural Disease, Mesothelioma,...
Phase PHASE1, PHASE2
Enrollment 113
Locations 6 sites
Compensation Phase 1: Typically $1,000-$5,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • iCasp9M28z T cell infusions
  • cyclophosphamide
  • pembrolizumab

Primary Outcomes

  • Composite measure of severity and number of adverse events (AEs); changes in (clinical laboratory test findings (hematologic and chemistry); and physical examination. (Phase I)
  • clinical benefit rate (phase II)
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE1, PHASE2
Status: Active, positions filled
Start Date: 2015-05
Completion: 2027-04-30
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 113 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: Bellicum Pharmaceuticals, United States Department of Defense
Principal Investigators:
  • Roisin O'Cearbhaill, MD (PRINCIPAL_INVESTIGATOR) - Memorial Sloan Kettering Cancer Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • iCasp9M28z T cell infusions
  • cyclophosphamide
  • pembrolizumab
Study Locations (6 sites)
Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up), Basking Ridge, New Jersey United States
Memorial Sloan Kettering Monmouth (Consent and Follow-Up), Middletown, New Jersey 07748 United States
Memorial Sloan Kettering Bergen (Consent and Follow-Up), Montvale, New Jersey 07645 United States
Memorial Sloan Kettering Commack (Consent and Follow-Up), Commack, New York United States
Memorial Sloan Kettering Westchester (Consent and Follow-Up), Harrison, New York 10604 United States
Memorial Sloan Kettering Cancer Center (Consent and Follow-Up), New York, New York 10065 United States
Eligibility Criteria
Inclusion Criteria: * Patients with MPD aged ≥18 years * Karnofsky performance status ≥70% * Patients with malignant pleural disease (MPD), pathologically confirmed at MSKCC (radiographic confirmation is acceptable for screening phase eligibility), and defined as one of the following (patients who have not yet received treatment may enroll in the screening portion only): 1. Malignant pleural mesothelioma - previously treated with at least one prior treatment regimen. 2. Non-small cell lung cancer metastatic to the pleura-previously treated with at least one prior treatment regimen (chemotherapy or targeted agent) and documented progression of disease. Patients with disease outside of the pleura will be discussed among study PI and Co-PIs prior to considered eligible for the study. Disease outside of the pleura must not require any immediate therapy per PI's discretion. 3. Breast cancer metastatic to the pleura- previously treated with at least one prior treatment regimen (chemotherapy or targeted agent) and documented progression of disease. Patients with disease outside of the pleura will be discussed among study PI and Co-PIs prior to be considered eligible for the study. Disease outside of the pleura must not require any immediate therapy per PI's discretion. * Only patients with a diagnosis of malignant pleural mesothelioma will be included in cohort 9 and in the Phase II portion of the study * Expression of mesothelin must be confirmed by meeting one of the following criteria. 1. Mesothelin expression (\>10% of the tumor expressing mesothelin) by immunohistochemical (IHC) analysis 2. Elevated serum SMRP levels (\>1.0 nM/L). * Free flowing pleural effusion requiring management by placement of a pleural catheter. Patients with a functional pleural catheter already in place are eligible for the study, as long as there are no clinical concerns of infection. OR * No free-flowing pleural effusion: an Interventional Radiologist has agreed that radiology-guided intrapleural or peritumoral injection of the CAR T cells is feasible. * Chemotherapy, targeted therapy (such as a tyrosine kinase inhibitor) or therapeutic radiotherapy must have been completed at least 14 days prior to administration of T cells. Continuation of hormonal therapy (ie for breast cancer) is acceptable. Prior immunotherapy with checkpoint blockade (i.e. PD1 inhibitor, PDL1 inhibitor or CTL4-antagonist or similar agent) must have been completed more than 1 month1prior to the T cell infusion. * Chemotherapy must have been completed at least 7 days prior to leukapheresis * Palliative radiotherapy must be completed at least 2 days prior to administration of cyclophosphamide * Any major thoracic (thoracotomy with lung or esophageal resection) or abdominal (laparotomy with organ resection) operation must have occurred at least 28 days before study enrollment. Patients who have undergone diagnostic VATS or laparoscopy can be included in the study. * All acute toxic effects of any previous therapeutic or palliative radiotherapy, chemotherapy, or surgical procedures must have resolved to grade I or lower according to CTCAE (version 4.0). * Lab requirements (hematology) * White blood cell (WBC) count ≥3000 cells/mm3 * Absolute neutrophil count ≥1500 neutrophils/mm3 * Platelet count ≥100,000 platelets/mm3 Lab requirements (serum chemistry) * Bilirubin ≤ 1.5x upper limit of normal (ULN) * Serum alanine aminotransferase and serum aspartate aminotransferase (ALT/AST) ≤.5x ULN * Serum creatinine ≤ 1.5x ULN or Cr \> 1.5x ULN, but calculated clearances of \>60 * Negative screen for human immunodeficiency virus (HIV), hepatitis B virus (HBV) antigen, and hepatitis C virus (HCV). If testing was performed during the previous 3 months, there is no need to repeat testing, as long as documentation of results is provided to the study site. Subjects must receive counseling and sign a separate informed consent form for HIV testing. * Subjects and their partners with reproductive potential must agree to use an effective form of contraception during the period of drug administration and for 4 weeks after completion of the last administration of the study drug. An effective form of contraception is defined as oral contraceptives plus 1 form of barrier or double-barrier method contraception (condom with spermicide or condom with diaphragm). * Subjects must be able to understand the potential risks and benefits of the study and must be able to read and provide written, informed consent for the study Exclusion Criteria: * Untreated or active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control); patients with a history of treated CNS metastases are eligible, provided that all of the following criteria are met: * Presence of measurable or evaluable disease outside of the CNS; * Radiographic demonstration of improvement upon completion of CNS-directed therapy and no evidence of interim progression between completion of CNS-directed therapy and the screening radiographic study; * Completion of radiotherapy ≥8 weeks prior to the screening radiographic study; * Discontinuation of corticosteroids and anticonvulsants ≥4 weeks prior to the screening radiographic study. * Non-small cell lung cancer metastatic to the pleura that extends outside of the pleura requiring immediate therapy * Breast cancer metastatic to the pleura that extends outside of the pleura requiring immediate therapy * Prior history of seizure disorder * Patients currently receiving treatment for concurrent active malignancy Continuation of hormonal therapy (i.e. for breast cancer) is acceptable. Prior immunotherapy with checkpoint blockade (i.e. PD1 inhibitor, PDL1 inhibitor or CTL4-antagonist or similar agent) must have been completed more than 1 month prior to the T cell infusion. * Autoimmune or antibody-mediated disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis (Patients with a history of hypothyroidism will not be excluded) * History of myocarditis or congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), as well as unstable angina, serious uncontrolled cardiac arrhythmia, uncontrolled infection, or myocardial infarction 6 months prior to study entry * Subjects with left ventricular ejection fraction (LVEF) less than 50% * Patients with active interstitial lung disease (ILD)/pneumonitis or a history of ILD/pneumonitis requiring treatment with systemic steroids * Baseline pulse oximetry is less than 92% on Room air * Pregnant or lactating women * An infection requiring antibiotic treatment within 7 days before the start of treatment (day 0) * A requirement for daily systemic corticosteroids for any reason or a requirement for other immunosuppressive or immunomodulatory agents. Topical, nasal, and inhaled steroids are permitted. * Administration of live, attenuated vaccine within 8 weeks before the start of treatment (day 0) and throughout the study * Any other medical condition that, in the opinion of the PI, may interfere with a subject's participation in or compliance with the study
FES PET/CT in Predicting Response in Patients With Newly Diagnosed Metastatic Breast Cancer Receiving Endocrine Therapy
NCT02398773
Active, positions filled
Conditions HER2/Neu Negative, Progesterone Receptor...
Phase PHASE2
Enrollment 99
Locations 25 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
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Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Computed Tomography
  • F-18 16 Alpha-Fluoroestradiol
  • Laboratory Biomarker Analysis
  • Positron Emission Tomography

Primary Outcomes

  • Negative predictive value of 18F FES uptake for response (CB), defined as the proportion of patients with a negative FES test result who have progressive disease
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2016-05-04
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 99 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: National Cancer Institute (NCI)
Principal Investigators:
  • Farrokh Dehdashti (PRINCIPAL_INVESTIGATOR) - ECOG-ACRIN Cancer Research Group
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • Computed Tomography
  • F-18 16 Alpha-Fluoroestradiol
  • Laboratory Biomarker Analysis
  • Positron Emission Tomography
Study Locations (25 sites)
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama 35233 United States
City of Hope Comprehensive Cancer Center, Duarte, California 91010 United States
Los Angeles General Medical Center, Los Angeles, California 90033 United States
USC / Norris Comprehensive Cancer Center, Los Angeles, California 90033 United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana 46202 United States
Sidney and Lois Eskenazi Hospital, Indianapolis, Indiana 46202 United States
Springmill Medical Center, Indianapolis, Indiana 46290 United States
Mayo Clinic in Rochester, Rochester, Minnesota 55905 United States
Washington University School of Medicine, St Louis, Missouri 63110 United States
Mount Sinai Hospital, New York, New York 10029 United States
Eligibility Criteria
Inclusion Criteria: * Capable and willing to provide informed consent * Women must not be pregnant or breast-feeding. All females of childbearing potential must have a blood test or urine study within 7 days prior to FES PET/CT scan and \[18F\]-fluorodeoxyglucose (FDG)-PET/CT scan to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: * Has not undergone a hysterectomy or bilateral oophorectomy or * Has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) * Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study * Patient is a postmenopausal woman, man, or premenopausal woman for whom standard endocrine therapy alone (tamoxifen, aromatase inhibitor \[AI\], with or without ovarian suppression or fulvestrant) is planned after FES-PET/CT is completed * Medically stable as judged by patient's physician * Life expectancy must be estimated by patient's physician at \> 6 months * Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (restricted to ECOG performance status \[PS\] 0-2 if age \> 70 years) * Patient must NOT have a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-FES * Patient must NOT be in liver failure as judged by the patient's physician * Histologically confirmed metastatic breast cancer * Primary tumor and/or metastatic site must be ER+ and may be progesterone-receptor positive (PgR+) or progesterone-receptor negative (PgR-) by IHC; patients with a history of an estrogen-receptor negative (ER-) primary tumor and a documented ER+ metastatic site are eligible * The pathology report and either (1) tissue (blocks or an unstained slides) or (2) a photomicrograph of the ER IHC slides from at least one site of metastatic disease and/or from primary breast cancer must be available for central review and analysis * NOTE: if photomicrographs are submitted, the submission of hematoxylin and eosin (H\&E), PR and Ki67 IHC's, if performed, are also to be submitted * Patient must NOT have human epidermal growth factor-2 positive (HER2+) metastatic disease * Patient must NOT be planning to receive molecular targeted therapy (such as everolimus or palbociclib) nor HER2 directed therapy in addition to endocrine therapy * Patient must NOT have received prior endocrine therapy for metastatic disease (i.e., must be first-line endocrine therapy for metastatic disease) * Patient is not now, and never has received adjuvant endocrine therapy OR patient is currently receiving or has received adjuvant endocrine therapy in the past, AND adjuvant endocrine therapy was initiated \> 2 years prior to diagnosis of metastatic disease * Note: patients who developed metastatic disease while still receiving adjuvant endocrine therapy must have a planned change in the type of endocrine agent used for subsequent metastatic disease treatment; patient is not receiving blocking adjuvant therapy (such as toremifene or tamoxifen) OR patient is receiving blocking adjuvant therapy, but will stop this therapy a minimum of 60 days prior to FES-PET/CT while still complying with the study timeline * Patient must NOT have a history of \> 1 line of administered chemotherapy for metastatic disease and must be off chemotherapy for a minimum of 2 weeks; prior chemotherapy in the adjuvant setting is allowed * Disease may be measurable (by Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1 criteria) or non-measurable but must be present in at least one non-liver site, where presence is defined as 1.5 cm or greater and visualized on PET/CT with \[18F\]-fluorodeoxyglucose (FDG); patients with effusion only disease or disease only in the liver are not eligible for the study * Patient must be able to lie still for a 20-30 minute PET/CT scan * Patient must NOT weigh more than the maximum weight limit for the table for the PET/CT scanner at the institution where the study is being performed * The patient is participating in the trial at an institution which has agreed to perform the imaging research studies, completed the ECOG-American College of Radiology Imaging Network (ACRIN) defined scanner qualification procedures and received ECOG-ACRIN (or current ACRIN) approval
Effects of High Altitude on AMPK Activation
NCT02391519
Recruiting
Conditions Pregnancy, IUGR, Preeclampsia
Phase Not Applicable
Enrollment 84
Locations 1 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • Collection of myometrial, cord blood, and placental tissue samples

Primary Outcomes

  • Changes in Myometrial artery dimensions
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: 2016-01
Completion: 2026-12-31
Eligibility
Age: 18 Years
Sex: FEMALE
Volunteers: true
Enrollment: 84 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: University of Colorado, Denver
Principal Investigators:
  • Lorna Moore, PhD (PRINCIPAL_INVESTIGATOR) - University of Colorado, Denver
Contact Information
Study Contact:
Lorna Moore, PhD
303-724-7474
lorna.moore@ucdenver.edu
Interventions
  • Collection of myometrial, cord blood, and placental tissue samples
Study Locations (1 sites)
University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado 80045 United States
Eligibility Criteria
Inclusion Criteria: * Women scheduled for cesarean delivery at University of Colorado Hospital (Denver, 1600 m) and St. Anthony's Summit Medical Center (Summit County, 3000 m) * Cesarean delivery at a prescheduled time without any labor, typically at 39 weeks gestation Exclusion Criteria: * Women will be excluded if there are co-existing medical diagnoses that are known to affect vascular parameters (i.e., diabetes mellitus, gestational diabetes, any hypertensive disorder of pregnancy, or a current smoker). * Women with multiple gestations and preterm deliveries will also be excluded.
T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA
NCT02326974
Active, positions filled
Conditions HER-2 Positive Breast Cancer, Breast Can...
Phase PHASE2
Enrollment 164
Locations 4 sites
Compensation Phase 2: Typically $500-$2,000
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • T-DM1
  • Pertuzumab
  • Excision of tumor/mastectomy

Primary Outcomes

  • Rate of Pathologic Complete Response (pCR) by HER2 Amplification Status Non-Heterogeneous
Interested in this trial?
Contact the study team directly or view the official listing
Study Information
Type: INTERVENTIONAL
Phase: PHASE2
Status: Active, positions filled
Start Date: 2015-01
Completion: 2028-01
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 164 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: Dana-Farber Cancer Institute
Collaborators: Genentech, Inc.
Principal Investigators:
  • Otto Metzger, MD (PRINCIPAL_INVESTIGATOR) - Dana-Farber Cancer Institute
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • T-DM1
  • Pertuzumab
  • Excision of tumor/mastectomy
Study Locations (4 sites)
Massachusetts General Hospital, Boston, Massachusetts 02114 United States
Dana Farber Cancer Institute, Boston, Massachusetts 02215 United States
Tennessee Oncology/Sarah Cannon Research Institute, Nashville, Tennessee 37203 United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee 37232 United States
Eligibility Criteria
Inclusion Criteria: * Patients must have HER2-positive Stage II or III histologically confirmed invasive carcinoma of the breast. A minimum tumor size of 2 cm determined by physical exam or imaging is required. * HER-2 positive, confirmed by central testing (Clarient labs): IHC 3+ and/or FISH positive based on one of the three following criteria: * Single-probe average HER2 copy number≥6.0 signals/cell OR * Dual-probe HER2/CEP17 \<2.0 with an average HER2 copy number ≥6.0 signals/cell OR * Dual-probe HER2/CEP17 ratio ≥2.0 * ER/PR determination is required. * Bilateral breast cancers are allowed if both cancers are HER2-positive. * Patients with multifocal or multicentric disease are eligible as long as one area meets eligibility criteria. * Breast imaging should include the ipsilateral axilla. For subjects with a clinically negative axilla, a sentinel lymph node biopsy will be performed either before or after preoperative therapy at the discretion of the subject's physicians. For subjects with a clinically positive axilla, a needle aspiration, core biopsy or SLN procedure will be performed to determine the presence of metastatic disease in the lymph nodes. * Men and women (with any menopausal status) ≥ 18 years of age * ECOG performance status 0 or 1 * Required laboratory values: * ANC ≥1500/mm3 * Hemoglobin ≥ 9 g/dl * Platelets ≥100,000/mm3 * Serum creatinine \< 1.5 X ULN (institutional) * Total bilirubin ≤ 1.0 X ULN (institutional) For patients with Gilbert syndrome, the direct bilirubin should be within the institutional normal range. * AST and ALT ≤ 1.5x ULN (institutional) * Alkaline phosphatase ≤1.5x ULN (institutional) * Documentation of hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies is required: this includes hepatitis B surface antigen (HBsAg) and/or total hepatitis B core antibody (HBcAb) in addition to HCV antibody testing. * Only for patients who test positive for hep B/C virus: PTT/INR \< ULN (institutional) * Left ventricular ejection fraction (LVEF) ≥ 55% * Premenopausal women must have a negative serum pregnancy test, including women who have had a tubal ligation and for women less than 12 months after the onset of menopause. * Women of childbearing potential and men with partners of childbearing potential must be willing to use one highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner and continue its use for the duration of the study treatment and for 7 months after the last dose of study treatment. * Potent CYP3A4 inhibitors, such as ketoconazole and erythromycin, should be avoided during the study treatment period with T-DM1. * Excessive alcohol intake should be avoided (occasional use is permitted). * Patients with a history of ipsilateral DCIS are eligible. * Patients undergoing breast conservation therapy (i.e. lumpectomy) must not have any contraindications to radiation therapy. * Willing and able to sign informed consent. * Willing to provide tissue for research purposes. Exclusion Criteria: * Pregnant or nursing women due to the teratogenic potential of the study drugs. * Active, unresolved infection. * Receipt of intravenous antibiotics for infection within 7 days prior to enrollment. * Patients with active liver disease, for example, due to hepatitis B virus, hepatitis C virus, autoimmune hepatic disorder, or sclerosing cholangitis. * Uncontrolled hypertension (systolic \>180 mm Hg and/or diastolic \>100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) Grade II or higher, or serious cardiac arrhythmia requiring medication. * Significant symptoms (Grade ≥2) peripheral neuropathy. * Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes. * Any prior treatment for the current breast cancer, including chemotherapy, hormonal therapy, radiation or experimental therapy.
Sweden Cancerome Analysis Network - Breast : Genomic Profiling of Breast Cancer
NCT02306096
Recruiting
Conditions Breast Neoplasms
Phase Not Applicable
Enrollment 20000
Locations 9 sites
Compensation Compensation varies
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Primary Outcomes

  • Biomarkers and clinicopathological information
  • Invasive disease-free survival
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: 2010-08
Completion: 2031-08
Eligibility
Age: No restriction
Sex: ALL
Volunteers: false
Enrollment: 20000 (ESTIMATED)
Sponsor & Investigators
Lead Sponsor: Lund University
Collaborators: South Sweden Breast Cancer Group, Mrs. Berta Kamprad Foundation, U-CAN
Principal Investigators:
  • Åke Borg, PhD (STUDY_DIRECTOR) - Lund University
  • Cecilia Hegardt, PhD (STUDY_CHAIR) - Lund University
  • Christer Larsson, PhD (PRINCIPAL_INVESTIGATOR) - Lund University
Contact Information
Study Contact:
Åke Borg, PhD
+46-46-2752552
ake.borg@med.lu.se
Lao Saal, MD, PhD
lao.saal@med.lu.se
Interventions
N/A
Study Locations (9 sites)
Hallands Hospital Halmstad, Halmstad, 30233 Sweden
Helsingborg Hospital, Helsingborg, 25187 Sweden
Kirurgiska kliniken, Jönköping, 55185 Sweden
Blekinge County Hospital, Karlskrona, 37185 Sweden
Central Hospital Kristianstad, Kristianstad, 29185 Sweden
Skåne University Hospital, Lund, 22185 Sweden
Skåne University Hospital, Malmö, 20502 Sweden
Uppsala University Hospital, Uppsala, 75185 Sweden
Central Hospital Växjö, Vaxjo, 35234 Sweden
Eligibility Criteria
Inclusion Criteria: * suspicion or confirmed diagnosis of primary breast cancer * signed informed consent Exclusion Criteria: * lack of signed informed consent
Copper Cu 64 Anti-CEA Monoclonal Antibody M5A PET in Diagnosing Patients With CEA Positive Cancer
NCT02293954
Active, positions filled
Conditions Breast Cancer, Colon Cancer, Extrahepati...
Phase NA
Enrollment 20
Locations 1 sites
Compensation Compensation typically provided
Data Updated 2026-07-28
Click to view full details
Study Details Design, interventions, and primary outcomes

Interventions / Regimen

  • radionuclide imaging
  • positron emission tomography
  • laboratory biomarker analysis
  • pharmacological study
  • Cu 64 anti-CEA monoclonal antibody M5A IV

Primary Outcomes

  • Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 1
  • Tumor Uptake of 64Cu-DOTA-hT4.66-M5A at Day 2
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: 2015-11-11
Completion: 2026-08-11
Eligibility
Age: 18 Years
Sex: ALL
Volunteers: false
Enrollment: 20 (ACTUAL)
Sponsor & Investigators
Lead Sponsor: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Principal Investigators:
  • Jeffrey Wong (PRINCIPAL_INVESTIGATOR) - City of Hope Medical Center
Contact Information
No direct contact listed - use the ClinicalTrials.gov link below to reach the study team
Interventions
  • radionuclide imaging
  • positron emission tomography
  • laboratory biomarker analysis
  • pharmacological study
  • Cu 64 anti-CEA monoclonal antibody M5A IV
Study Locations (1 sites)
City of Hope Medical Center, Duarte, California 91010 United States
Eligibility Criteria
Inclusion Criteria: * Patients must have histologically confirmed primary or metastatic cancer; if biopsies were performed at an outside facility, the histology must be reviewed and confirmed by the Department of Pathology at the City of Hope * Patients must have tumors that produce CEA as documented by a current or past history of an elevated serum CEA above the institutional limit of normal, or by immunohistochemical methods; NOTE: Patients with colorectal cancer are exempt from this requirement since \> 95% are CEA positive * Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately * Patients must have a known site of disease; please note, for patients undergoing neoadjuvant therapy, this requirement must be met retrospectively prior to the start of neoadjuvant therapy; patients who are in radiological/clinical remission after neoadjuvant therapy, prior to infusion of radiolabeled antibody, are still eligible * Although not mandated by the protocol, the results of the CT scan and labs (complete blood count \[CBC\], comprehensive metabolic panel \[CMP\]) that are performed as part of the standard work up should be available and should have been done within 2 months prior to study entry * All subjects must have the ability to understand and the willingness to sign a written informed consent * Prior therapy (chemotherapy, immunotherapy, radiotherapy) must be completed at least 2 weeks prior to infusion of radiolabeled antibody Exclusion Criteria: * Patients should not have any uncontrolled illness including ongoing or active infection * History of allergic reactions attributed to compounds of similar chemical or biologic composition to copper Cu 64 anti-CEA monoclonal antibody M5A (64Cu-M5A) * Patients must not have received prior chemotherapy or radiation for \>= 2 weeks before study enrollment * Pregnant women are excluded from this study; breastfeeding should be discontinued is the mother is treated with 54Cu-m5A * Any patient who has had exposure to mouse or chimeric (human/mouse) immunoglobulin and has antibody to the M5A * Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study