Clinical trials: High-risk Breast Cancer
Breast Cancer
Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative…
- Trial name
- monarchE (NCT03155997)
- Testing
- Abemaciclib, Standard Adjuvant Endocrine Therapy
- Where
- 619 sites in United States, Argentina and 36 more
- Volunteers
- 5,637 people
- Sponsor
- Eli Lilly and Company
Advanced Malignancies, Metastatic Cancer
Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of INCAGN01876 Combined With Immune Therapies in Advanced or Metastatic Malignancies
The purpose of this study is to determine the safety, tolerability, and efficacy of INCAGN01876 when given in combination with immune therapies in subjects with advanced or metastatic malignancies.
- Trial name
- NCT03126110
- Testing
- INCAGN01876, Nivolumab, Ipilimumab
- Where
- 38 sites in United States, Australia and 2 more
- Volunteers
- 145 people
- Sponsor
- Incyte Biosciences International Sàrl
Breast Cancer, Chronic Myeloproliferative Disorders
Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant
RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.
- Conditions
- Breast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor, Leukemia
- Trial name
- NCT00293384
- Testing
- Aprepitant, Cyclophosphamide, Dexamethasone
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Barbara Ann Karmanos Cancer Institute
Breast Neoplasms, Bone and Bones
Calcitriol, Physical Activity, and Bone Health in Cancer Survivors
Both the calcitriol and exercise interventions are aimed at reducing fracture risk by maintaining proper bone density, thereby preventing osteoporotic/osteopenic conditions and increasing muscle mass.
- Trial name
- NCT00904033
- Testing
- Calcitriol, Exercise, Multivitamin
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- University of Rochester
Breast Cancer
Adjuvant Doxorubicin/Cyclophosphamide and Paclitaxel Plus Sorafenib Breast Cancer
Sorafenib is being looked at in a number of solid tumor settings including breast cancer. This trial is designed as a pilot study to assess the safety and tolerability of a novel oral agent in combination with standard…
- Trial name
- NCT00544167
- Testing
- Doxorubicin, Cyclophosphamide, Paclitaxel
- Where
- 8 sites in United States
- Volunteers
- 45 people
- Sponsor
- SCRI Development Innovations, LLC
Stage IV Breast Cancer
Vaccination of High Risk Breast Cancer Patients
Objective - Determine the safety and tolerability of a peptide mimotope-based vaccine upon immunization of breast cancer subjects.
- Trial name
- NCT01390064
- Testing
- Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Arkansas
Breast Cancer
Safety & Efficacy of Three Docetaxel-Based Chemotherapy Regimens Plus Bevacizumab With or Without Trastuzumab for Adjuvant Treatment of Patients With Breast Cancer
This is a phase IIb, randomized, parallel-group, noncomparative, multicenter, pilot study designed to evaluate the safety and efficacy of bevacizumab with or without (+/-) trastuzumab administered with three different…
- Trial name
- NCT00365365
- Testing
- Doxorubicin and cyclophosphamide (AC) + bevacizumab, Docetaxel (T) + bevacizumab, Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab
- Where
- United States
- Volunteers
- 214 people
- Sponsor
- Sanofi
Triple Negative Breast Cancer
QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy.
This is a phase 1b/2 study to evaluate the safety and efficacy of metronomic combination therapy in subjects with TNBC who have progressed on or after previous SoC chemotherapy.
- Trial name
- NCT03387085
- Testing
- Aldoxorubicin HCl, N-803, ETBX-011
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- ImmunityBio, Inc.
Breast Neoplasms
Exemestane and Celecoxib in Postmenopausal Women at High Risk for Breast Cancer
The primary goal of this 5-year study is to determine whether exemestane alone or in combination with celecoxib decreases breast tissue density in healthy postmenopausal women at high risk for breast cancer.
- Trial name
- NCT00073073
- Testing
- Exemestane, Calcium carbonate, Vitamin D
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- Georgetown University
Breast Cancer
Olive Oil for High Risk Breast Cancer Prevention in Women
This is a pilot study evaluating the effect of hydroxytyrosol, a component of olive oil, on mammographic density in women at high risk of developing breast cancer.
- Trial name
- NCT02068092
- Testing
- Hydroxytyrosol
- Where
- 3 sites in United States
- Volunteers
- 51 people
- Sponsor
- The Methodist Hospital Research Institute
Breast Neoplasms
Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates
This multicenter trial using Hologic digital mammography units will evaluate the specificity of 2-D full field digital mammography (FFDM) versus a combination of 2-D and 3-D tomosynthesis imaging in breast cancer screening.
- Trial name
- NCT01236781
- Testing
- Screening Tomosynthesis, Diagnostic Tomosynthesis
- Where
- 2 sites in United States
- Volunteers
- 558 people, healthy volunteers welcome
- Sponsor
- American College of Radiology
Breast Adenocarcinoma
Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer
This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph…
- Trial name
- NCT00433511
- Testing
- Bevacizumab, Cyclophosphamide, Doxorubicin Hydrochloride
- Where
- 842 sites in United States, Peru and 1 more
- Volunteers
- 4,994 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Breast Cancer Risk Biomarkers in Premenopausal Women
This study is designed to gather information on how the prescription drug Lovaza™ which contains omega-3 fatty acids, affects blood and tissue risk biomarkers for breast cancer.
- Trial name
- NCT01252277
- Testing
- Lovaza™
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Carol Fabian, MD
Breast Cancer
Barriers to Screening Breast MRI Utilization Among Patients at Elevated Risk
This study seeks to develop an explanatory framework for breast MRI utilization to inform future interventions. The Health Services Utilization Model (HSUM) will guide the selection of specific participant-level factors for…
- Trial name
- B-SUPER (NCT04257474)
- Testing
- Self-Report Survey, Qualitative Interviews
- Where
- 2 sites in United States
- Volunteers
- 265 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Breast Cancer
HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer
The purpose of this study is to determine the safety and immunogenicity of HER-2 pulsed DC1 vaccine in high risk HER-2 high and intermediate expression breast cancers.
- Trial name
- Adjuvant (NCT02063724)
- Testing
- HER-2 pulsed Dendritic Cell Vaccine
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Breast Cancer
Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer
RATIONALE: 1. . To compare the effects on breast cancer of three different combinations of drugs which are commonly used to treat this disease. 2. . It is not yet known which treatment regimen is most effective for breast cancer.
- Trial name
- NCT00014222
- Testing
- epoetin alfa, filgrastim, cyclophosphamide
- Where
- 78 sites in United States, Canada
- Volunteers
- 2,104 people
- Sponsor
- NCIC Clinical Trials Group
Breast Cancer
Genistein in Preventing Breast Cancer in Women at High Risk for Breast Cancer
This randomized phase II trial is studying how well genistein works in preventing breast cancer in women at high risk for breast cancer.
- Trial name
- NCT00290758
- Testing
- genistein, laboratory biomarker analysis
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- National Cancer Institute (NCI)
Pre-diabetes, Breast Cancer
Time Restricted Eating on Cancer Risk
Participants will be randomly assigned to either the time restricted feeding group with a daily eating period of 8 hours or the control group with a daily eating period of greater than or equal to 12 hours.
- Conditions
- Pre-diabetes, Breast Cancer, Time Restricted Feeding
- Trial name
- TREC (NCT05038137)
- Testing
- Time restricted feeding, Control
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Medical University of South Carolina
Metastatic Breast Cancer
A Study of Pertuzumab With High-Dose Trastuzumab for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (MBC) With Central Nervous System (CNS) Progression Post-Radiotherapy
This study will examine the safety and efficacy of pertuzumab in combination with high-dose trastuzumab in adult participants with HER2-positive MBC with CNS metastases and disease progression in the brain following radiotherapy.
- Trial name
- NCT02536339
- Testing
- Pertuzumab, Trastuzumab
- Where
- 16 sites in United States
- Volunteers
- 40 people
- Sponsor
- Genentech, Inc.
Breast Cancer
Assessing Response to Neoadjuvant Chemotherapy With HD PET/CT, Serum Glycomic Markers and Tissue Muc-1 Isoforms
A pilot study of adult (≥ 18 years) women with stage II-III breast cancer who will receive preoperative chemotherapy prior to mastectomy.
- Trial name
- ENIGMA (NCT01110174)
- Testing
- HD PET/CT
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of California, Davis