Clinical trials: ER Positive, HER2 Negative Breast Cancer
Breast Cancer
Cyclophosphamide, Methotrexate, and Prednisolone With or Without Aromatase Inhibitor Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, methotrexate, and prednisolone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00687648
- Testing
- anastrozole, cyclophosphamide, exemestane
- Where
- Singapore
- Volunteers
- 70 people
- Sponsor
- National Cancer Centre, Singapore
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor…
- Trial name
- NCT06065748
- Testing
- Giredestrant, Fulvestrant, Abemaciclib
- Where
- 311 sites in United States, Argentina and 35 more
- Volunteers
- 1,050 people
- Sponsor
- Hoffmann-La Roche
Hormone Receptor Positive Breast Cancer
Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer
The purpose of this study was to assess the efficacy and safety of first-line treatment with everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2…
- Trial name
- BOLERO-4 (NCT01698918)
- Testing
- Everolimus, Letrozole, Exemestane
- Where
- 52 sites in United States, Argentina and 11 more
- Volunteers
- 202 people
- Sponsor
- Novartis Pharmaceuticals
Postmenopausal Women With ER+ HER2- Primary Breast Cancer
Study to Compare the Effects of AZD9496 vs Fulvestrant in Breast Cancer.
This is an open label randomised multicentre pre-surgical pharmacodynamics study to compare and assess the biological effects of AZD9496 and fulvestrant in postmenopausal women with estrogen receptor (ER) positive (ER+), human…
- Trial name
- D6090C00002 (NCT03236974)
- Testing
- Standard Arm - Fulvestrant, AZD9496
- Where
- 12 sites in Germany, United Kingdom
- Volunteers
- 49 people
- Sponsor
- AstraZeneca
Advanced Breast Cancer
A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor
This study aimed at evaluating the safety and efficacy of everolimus plus exemestane in Chinese postmenopausal women with ER+ HER2- locally advanced, recurrent, or metastatic breast cancer after recurrence or progression on…
- Trial name
- BOLERO-5 (NCT03312738)
- Testing
- Everolimus, Exemestane
- Where
- 15 sites in China
- Volunteers
- 159 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Chemotherapy Omission in ER+/HER2- Breast Cancer With 1-3 Positive Lymph Nodes Receiving Extended Adjuvant Abemaciclib
This is a prospective, randomized, open-label, multicenter phase III study to explore chemotherapy omission in ER+/HER2-endocrine-sensitive breast cancer with 1-3 positive lymph nodes receiving extended (3 year) adjuvant…
- Trial name
- Rainbow (NCT06341621)
- Testing
- 3-year abemaciclib without chemo, treatment of physician's choice
- Where
- China
- Volunteers
- 1,900 people
- Sponsor
- Fudan University
Breast Cancer, Node-positive Breast Cancer
Hypofractionated Regional Nodal Irradiation Clinical Trial for Women With Breast Cancer
Single-arm, phase 2 study evaluating hypofractionated irradiation of breast and regional nodes in women with breast cancer. Patients will be grouped in 3 surgery-related treatment groups: 1) An intact breast following lumpectomy…
- Conditions
- Breast Cancer, Node-positive Breast Cancer, Breast Adenocarcinoma, Invasive Breast Carcinoma
- Trial name
- NCT02515110
- Testing
- External Beam Radiation Therapy
- Where
- 2 sites in United States
- Volunteers
- 137 people
- Sponsor
- Virginia Commonwealth University
Breast Cancer
Molecular Triaging of Newly Diagnosed Breast Cancer
The goal of this clinical research study is to learn if using "gene signatures" can be an effective way to decide the best treatment for breast cancer patients.
- Trial name
- NCT01159236
- Testing
- Paclitaxel, Fluorouracil, Doxorubicin
- Sponsor
- M.D. Anderson Cancer Center
HER2-positive Breast Cancer, Metastatic Cancer
PRE-ISPY Phase I/II Oncology Platform Program
PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced…
- Conditions
- HER2-positive Breast Cancer, Metastatic Cancer, Metastatic Breast Cancer, Metastatic
- Trial name
- PRE-ISPY (NCT05868226)
- Testing
- ALX148, Fam-Trastuzumab Deruxtecan-Nxki, Zanidatamab
- Where
- 10 sites in United States
- Volunteers
- 280 people
- Sponsor
- QuantumLeap Healthcare Collaborative
Breast Neoplasms, Invasive Breast Cancer
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer.
- Conditions
- Breast Neoplasms, Invasive Breast Cancer, Estrogen-receptor-positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- EVANGELINE (NCT05607004)
- Testing
- (Z)-endoxifen, goserelin
- Where
- 14 sites in United States
- Volunteers
- 87 people
- Sponsor
- Atossa Therapeutics, Inc.
Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer
BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer
This phase I trial studies the side effects and best dose of the PI3K inhibitor BYL719 when given together with letrozole in treating patients with hormone receptor-positive metastatic breast cancer.
- Conditions
- Estrogen Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Invasive Ductal Breast Carcinoma, Progesterone Receptor-positive Breast Cancer
- Trial name
- NCT01791478
- Testing
- PI3K inhibitor BYL719, letrozole, laboratory biomarker analysis
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- Vanderbilt-Ingram Cancer Center
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.
Breast Cancer
(Oncotype DX®) in Estrogen Receptor Positive (ER+) HER-2 Negative (HER 2-) 1-3 Node Positive (pN1) Breast Cancer
This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay on the decision making of the treating physician and the patient.
- Trial name
- NCT02627703
- Testing
- Oncotype DX
- Where
- Canada
- Volunteers
- 80 people
- Sponsor
- British Columbia Cancer Agency
Breast Cancer Stage II
Neoadjuvant and Adjuvant Ribociclib and ET for Clinically High-risk ER+ and HER2- Breast Cancer
This is an open-label, multicenter international trial in men and women with primary operable HR+/HER2-, ki67≥20%, grade 2 or 3 and stage II breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in…
- Trial name
- RIBOLARIS (NCT05296746)
- Testing
- Ribociclib (neoadjuvant), Chemotherapy (adjuvant), Ribociclib (adjuvant)
- Where
- 51 sites in France, Portugal and 1 more
- Volunteers
- 1,100 people
- Sponsor
- SOLTI Breast Cancer Research Group
Early Breast Cancer, Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-)
A Study of a Medicine Called Atirmociclib in Combination With Giredestrant in Adult Participants With ER-positive, HER2-negative Early-stage Breast Cancer
This Phase 3 study will evaluate whether atirmociclib plus giredestrant improves invasive breast cancer-free survival compared with giredestrant alone in adults with ER-positive, HER2-negative early breast cancer at medium or…
- Trial name
- NCT07890597
- Testing
- Atirmociclib, giredestrant
- Volunteers
- 3,800 people
- Sponsor
- Pfizer
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
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
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