Clinical trials: Breast Cancer, Estrogen Receptor-Positive
Breast Cancer
Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer
This was an open label, multi-center protocol for U.S. patients enrolled in the study of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk early breast…
- Trial name
- EarLEE-1 (NCT03078751)
- Testing
- Ribociclib, Adjuvant endocrine therapy
- Where
- 33 sites in United States
- Volunteers
- 54 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment
The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall survival for elderly patients with breast cancer, in a sub group with a high risk of relapse according to Genomic Grade test.
- Trial name
- ASTER 70s (NCT01564056)
- Testing
- HORMONOTHERAPY, CHEMOTHERAPY then HORMONOTHERAPY
- Where
- 84 sites in Belgium, France
- Volunteers
- 1,989 people
- Sponsor
- UNICANCER
HER2-Positive Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma
Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer
This randomized phase III trial studies docetaxel, carboplatin, trastuzumab, and pertuzumab with estrogen deprivation to see how they work compared to docetaxel, carboplatin, trastuzumab, and pertuzumab without estrogen…
- Conditions
- HER2-Positive Breast Carcinoma, Hormone Receptor-Positive Breast Carcinoma, Stage IB Breast Cancer AJCC v7, Stage IIA Breast Cancer AJCC v6 and v7
- Trial name
- NCT02003209
- Testing
- Aromatase Inhibition Therapy, Carboplatin, Cytology Specimen Collection Procedure
- Where
- 732 sites in United States, Puerto Rico
- Volunteers
- 315 people
- Sponsor
- National Cancer Institute (NCI)
Estrogen Receptor Positive, HER2/Neu Negative
Fulvestrant and Palbociclib With or Without Copanlisib in Treating Patients With Hormone Receptor Positive, HER2 Negative, Stage IV Breast Cancer
This randomized phase II trial studies the side effects and how well fulvestrant and palbociclib with or without copanlisib work in treating patients with hormone receptor positive, HER2 negative, stage IV breast cancer.
- Conditions
- Estrogen Receptor Positive, HER2/Neu Negative, Progesterone Receptor Positive, Stage IV Breast Cancer AJCC v6 and v7
- Trial name
- NCT03377101
- Testing
- Copanlisib, Fulvestrant, Laboratory Biomarker Analysis
- Sponsor
- National Cancer Institute (NCI)
Estrogen Receptor Positive, HER2/Neu Negative
Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer
This phase I/II trial studies side effects and best dose of copanlisib when given together with letrozole and palbociclib and to see how well they work in treating hormone receptor positive HER2 negative stage I-IV breast cancer.
- Conditions
- Estrogen Receptor Positive, HER2/Neu Negative, Invasive Breast Carcinoma, Multifocal Breast Carcinoma
- Trial name
- NCT03128619
- Testing
- Biopsy of Breast, Copanlisib, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Jonsson Comprehensive Cancer Center
Female Breast Cancer
Expectations and Side Effects of Endocrine Therapy in Women With Breast Cancer
The purpose of this study is to evaluate the role of patients' response expectations for nocebo side effects, quality of life and adherence during adjuvant endocrine treatment (AET).
- Trial name
- NCT02088710
- Testing
- Enhanced information about endocrine therapy
- Where
- Germany
- Volunteers
- 138 people
- Sponsor
- Philipps University Marburg
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8
High Cannabidiol Plant Extract (BRC-001) to Improve Aromatase Inhibitor-Induced Arthralgia in Women With Breast Cancer
This phase II trial tests the effectiveness of cannabidiol (CBD) plant extract (BRC-001) in improving joint stiffness and pain (arthralgia) in women with breast cancer taking aromatase inhibitors (AIs).
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
- Trial name
- NCT06538389
- Testing
- Biospecimen Collection, BRC-001, Questionnaire Administration
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- City of Hope Medical Center
Breast Cancer
Neoadjuvant Adebrelimab and Chemotherapy in High-rish ER+/HER2- BC
Investigators plan to conduct a single-arm clinical study of adebelimab, a novel PD-L1 inhibitor, in the neoadjuvant treatment of early or locally advanced high-risk ER+/HER2- breast cancer, to explore whether the addition of…
- Trial name
- NCT06500208
- Testing
- Adebrelimab combined with nab-paclitaxel, epirubicin and cyclophosphamide
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
ER-positive Breast Cancer, HER2-negative Breast Cancer
Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)
This is an international, multi-center, randomised, open label, superiority phase III trial of elacestrant vs standard endocrine therapy in patients with ER+/HER2- breast cancer and ctDNA relapse.
- Conditions
- ER-positive Breast Cancer, HER2-negative Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer
- Trial name
- TREAT ctDNA (NCT05512364)
- Testing
- Elacestrant, Tamoxifen, Letrozole 2.5mg
- Where
- 113 sites in Belgium, Cyprus and 10 more
- Volunteers
- 220 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Breast Cancer
Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer
This is a multicenter, Phase 1b-2 study of elacestrant in combination with onapristone in patients with advanced/metastatic ER+/PgR+/HER2- breast cancer.
- Trial name
- ELONA (NCT05618613)
- Testing
- Elacestrant, Onapristone
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Context Therapeutics Inc.
Breast Cancer
A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer
This study is looking at whether Metformin, an agent that is commonly used to treat diabetes, can decrease or affect the ability of breast cancer cells to grow and whether Metformin will work with other therapies to keep cancer…
- Trial name
- NCT01101438
- Testing
- metformin hydrochloride
- Where
- 344 sites in United States, Canada and 2 more
- Volunteers
- 3,649 people
- Sponsor
- Canadian Cancer Trials Group
Estrogen Receptor Positive Breast Cancer
[18F]Fluoroestradiol-PET/CT Companion Imaging Study to the FORESEE Trial
This protocol is a companion imaging study that will add FES-PET/CT imaging to the FORESEE trial at HCI. This study will establish the feasibility of using FES-PET/CT imaging to guide therapeutic decision making for functional…
- Trial name
- NCT04727632
- Testing
- [18F]Fluoroestradiol (FES) PET/CT
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Utah
Breast Cancer
Adjuvant Treatment Recommendation and Oncotype DX® in Early Breast Cancer
Oncotype DX® is likely to become more widely used in Europe as well as in Switzerland. The test is currently not reimbursed by the Swiss health insurances.
- Trial name
- NCT01926964
- Where
- 19 sites in Switzerland
- Volunteers
- 229 people
- Sponsor
- Swiss Cancer Institute
Invasive Breast Cancer (Stage I-III)
Neoadjuvant Endocrine Therapy Combined With Chemotherapy in ER-positive, HER2-negative Stage I-III Breast Cancer
The goal of this investigator-initiated, open-label, phase II clinical trial is to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with endocrine therapy in patients with hormone receptor-positive, human…
- Trial name
- NCT07801898
- Testing
- NaCET: For chemotherapy, the TEC or EC-T regimen is selected; for endocrine therapy, letrozole is administered; for premenopausal patients, an LHRH agonist-goserelin or leuprolide
- Where
- China
- Volunteers
- 36 people
- Sponsor
- The Second Hospital of Anhui Medical University
Metastatic Breast Cancer
Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer
This international, multicenter, prospective single arm Phase II biomarker discovery clinical trial with the primary objective of assessing the association of PFS with gene mutations, gene copy number aberrations and gene…
- Trial name
- PYTHIA (NCT02536742)
- Testing
- Palbociclib, Fulvestrant
- Where
- 19 sites in Belgium, Italy and 1 more
- Volunteers
- 124 people
- Sponsor
- ETOP IBCSG Partners Foundation
Breast Cancer
Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer
Primary Objectives: Dose Escalation: To assess the incidence rate of dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) as well as the recommended dose (RD) of amcenestrant administered as monotherapy…
- Trial name
- AMEERA-1 (NCT03284957)
- Testing
- Amcenestrant, Palbociclib, Alpelisib
- Where
- 25 sites in United States, Belgium and 8 more
- Volunteers
- 136 people
- Sponsor
- Sanofi
Breast Cancer
Fulvestrant With or Without Ganetespib in HR+ Breast Cancer
Ganetespib is a drug that may stop cancer cells from growing. This drug has been used in other research studies and laboratory experiments.
- Trial name
- NCT01560416
- Testing
- Fulvestrant, Ganetespib
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Dana-Farber Cancer Institute
Breast Cancer
Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy
The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive…
- Trial name
- FACT (NCT00256698)
- Testing
- Fulvestrant, Anastrozole
- Where
- 85 sites in Canada, Costa Rica and 10 more
- Volunteers
- 514 people
- Sponsor
- AstraZeneca
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Evaluation of a Once Per Day Regimen of Accelerated Partial Breast Irradiation for Improved Breast Appearance in Pts w/Low Risk, Hormone Responsive Brst Ca
This phase II trial tests how well accelerated partial breast irradiation (APBI) delivered once per day works in ensuring an acceptable breast appearance in patients with low risk, hormone responsive breast cancer.
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma, HER2-Negative Breast Carcinoma
- Trial name
- NCT06008158
- Testing
- Accelerated Partial Breast Irradiation
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- City of Hope Medical Center
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8
Carbon Dioxide Fractional Laser in Treating Participants With Stage 0-III Hormone Receptor-Positive Breast Cancer With Vulvovaginal Atrophy
This phase II trial studies how well carbon dioxide fractional (CO2RE) laser works in treating participants with stage 0-III hormone receptor-positive breast cancer with vulvovaginal atrophy associated with dryness, inflammation…
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
- Trial name
- NCT03666819
- Testing
- Carbon Dioxide Fractional Laser, Questionnaire Administration
- Sponsor
- Mayo Clinic