Clinical trials: ER-positive and HER2-negative Metastatic or Locally Advanced Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
This randomized phase II trial studies how well tamoxifen citrate works compared with z-endoxifen hydrochloride in treating patients with breast cancer that has spread to nearby tissue or lymph nodes or other parts of the body…
- Conditions
- Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7
- Trial name
- NCT02311933
- Testing
- Endoxifen Hydrochloride, Laboratory Biomarker Analysis, Pharmacological Study
- Where
- 559 sites in United States
- Volunteers
- 81 people
- Sponsor
- National Cancer Institute (NCI)
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer
This phase I trial investigates the side effects and best dose of abexinostat and palbociclib when given together with fulvestrant in treating patients with breast or gynecologic cancer.
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8
- Trial name
- NCT04498520
- Testing
- Abexinostat Tosylate, Fulvestrant, Palbociclib
- Sponsor
- Pamela Munster
Metastatic Breast Cancer
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
The purpose of this study is to assess the efficacy and safety of belzutifan (MK-6482) plus fulvestrant compared to everolimus plus endocrine therapy (ET) (investigator's choice of fulvestrant or exemestane) in adults with…
- Trial name
- NCT06428396
- Testing
- Belzutifan, Fulvestrant, Everolimus
- Where
- 41 sites in United States, Argentina and 7 more
- Volunteers
- 120 people
- Sponsor
- Merck Sharp & Dohme LLC
Metastatic Breast Cancer
4EVER - Efficacy, Safety, Health Economics, Translational Research of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer
The present multi-center, open-label, single-arm study aims to evaluate the efficacy and safety, quality of life and health resources utilization in postmenopausal women with hormone receptor positive breast cancer progressing…
- Trial name
- MACS2096 (NCT01626222)
- Testing
- Exemestane, Everolimus (RAD001)
- Where
- 84 sites in Germany
- Volunteers
- 301 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer
This clinical trial is evaluating a drug called AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer.
- Trial name
- NCT05080842
- Testing
- AC682
- Where
- 5 sites in United States
- Volunteers
- 21 people
- Sponsor
- Accutar Biotechnology Inc
Breast Cancer
A Study of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
This clinical trial is evaluating AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer. The main goals of this study are to: 1.
- Trial name
- NCT05489679
- Testing
- AC682
- Where
- 3 sites in China
- Volunteers
- 6 people
- Sponsor
- Accutar Biotechnology Inc
Breast Cancer
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
The purpose of this study is to assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or…
- Trial name
- MoonROSE (NCT07100106)
- Testing
- GDC-4198, Giredestrant, Abemaciclib
- Where
- 77 sites in United States, Australia and 8 more
- Volunteers
- 285 people
- Sponsor
- Genentech, Inc.
Breast Cancer
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
The purpose of this study is to determine the safety and efficacy of PF-07220060 with letrozole compared to approved treatments (ie, palbociclib, ribociclib or abemaciclib with letrozole) in people with breast cancer: HR-positive…
- Trial name
- FourLight-3 (NCT06760637)
- Testing
- PF-07220060, letrozole, abemaciclib
- Where
- 460 sites in United States, Argentina and 28 more
- Volunteers
- 1,035 people
- Sponsor
- Pfizer
Advanced Breast Carcinoma, Locally Advanced Breast Carcinoma
Genetic Analysis in Blood and Tumor Samples From Patients With Advanced or Metastatic Estrogen Receptor Positive and HER2 Negative Breast Cancer Receiving Palbociclib and Endocrine Therapy
This research trial studies genetic profiles in blood and tumor samples from patients with estrogen receptor positive and HER2 negative breast cancer that has spread to other places in the body who are receiving palbociclib and…
- Conditions
- Advanced Breast Carcinoma, Locally Advanced Breast Carcinoma, Metastatic Breast Carcinoma, Recurrent Breast Carcinoma
- Trial name
- NCT03281902
- Testing
- Biopsy, Biospecimen Collection, Laboratory Biomarker Analysis
- Where
- 3 sites in United States
- Volunteers
- 68 people
- Sponsor
- Mayo Clinic
Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer)
This Phase III, randomized, double-blind, placebo-controlled, multicenter study will evaluate the efficacy and safety of giredestrant combined with palbociclib compared with letrozole combined with palbociclib in patients with…
- Trial name
- NCT04546009
- Testing
- Giredestrant, Letrozole, Palbociclib
- Where
- 255 sites in United States, Argentina and 28 more
- Volunteers
- 992 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer, Breast Cancer Stage I
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Locally Advanced Breast Cancer (LABC)
- Trial name
- NCT07002177
- Testing
- FWD1802, Palbociclib 125mg, Ribociclib 200Mg Oral Tablet
- Where
- China
- Volunteers
- 196 people
- Sponsor
- Forward Pharmaceuticals Co., Ltd.
Breast Cancer
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
The purpose of this study is to learn about the safety and effects of the study medicine PF-07248144 when given along with fulvestrant for the possible treatment of HR-positive, HER2-negative advanced or metastatic breast cancer.
- Trial name
- NCT07062965
- Testing
- PF-07248144, Fulvestrant, Everolimus
- Where
- 433 sites in United States, Argentina and 29 more
- Volunteers
- 400 people
- Sponsor
- Pfizer
Her2 Negative Breast Cancer Patients
Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive and/or Progesterone Receptor Positive Her2 Negative Breast Cancer
To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer patients is more effective than Exemestane alone
- Trial name
- NCT01151046
- Testing
- MM-121, Exemestane
- Where
- 33 sites in United States, Canada and 3 more
- Volunteers
- 118 people
- Sponsor
- Merrimack Pharmaceuticals
Breast Neoplasms, Breast Cancer
Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive…
- Conditions
- Breast Neoplasms, Breast Cancer, Estrogen-receptor Positive Breast Cancer, Cancer, Breast
- Trial name
- NCT03250676
- Testing
- H3B-6545
- Where
- 39 sites in United States, France and 1 more
- Volunteers
- 151 people
- Sponsor
- Eisai Inc.
Metastatic Breast Cancer, HER2-negative Breast Cancer
Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.
Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
- Conditions
- Metastatic Breast Cancer, HER2-negative Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer
- Trial name
- TRACY-1 (NCT06590857)
- Testing
- RYZ101, Standard of Care Endocrine Therapy
- Where
- 31 sites in United States, Canada and 1 more
- Volunteers
- 64 people
- Sponsor
- RayzeBio, Inc.
Breast Cancer
Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.
The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is safe and effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6…
- Trial name
- TRINITI-1 (NCT02732119)
- Testing
- Ribociclib, Everolimus, Exemestane
- Where
- 25 sites in United States
- Volunteers
- 104 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Metastatic Breast Cancer
Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer
This was a national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety of treatment with ribociclib (LEE011) plus letrozole in patients with HR+, HER2-negative advanced (recurrent or metastatic)…
- Trial name
- NCT03096847
- Testing
- ribociclib, letrozole, goserelin
- Where
- 84 sites in Germany
- Volunteers
- 502 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with…
- Trial name
- SANDPIPER (NCT02340221)
- Testing
- Taselisib, Fulvestrant
- Where
- 157 sites in United States, Australia and 26 more
- Volunteers
- 631 people
- Sponsor
- Hoffmann-La Roche
ER-Positive, HER2-Negative Breast Cancer
A Phase 1 Study of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer
The study is to assess safety and tolerability of HRS8807 monotherapy and in combination with SHR6390 in subjects with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum…
- Trial name
- NCT04993430
- Testing
- HRS8807, HRS8807、SHR6390
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Breast Cancer
A Phase 1/2 Trial of ARV-471 Alone and in Combination With Palbociclib (IBRANCE®) in Participants With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
This was a Phase 1/2 dose escalation and cohort expansion study and assessed the safety, tolerability and anti-tumor activity of ARV-471 alone and in combination with palbociclib (IBRANCE®) in participants with estrogen receptor…
- Trial name
- mBC (NCT04072952)
- Testing
- Vepdegestrant, Palbociclib
- Where
- 16 sites in United States
- Volunteers
- 219 people
- Sponsor
- Arvinas Estrogen Receptor, Inc.