Clinical trials: Breast Cancer, Estrogen Receptor-Positive
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
Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery
RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer.
- Trial name
- NCT01349322
- Testing
- Standard fractionation whole breast irradiation, Hypofractionated whole breast irradiation, Concurrent boost
- Where
- 415 sites in United States, Canada and 6 more
- Volunteers
- 2,354 people
- Sponsor
- Radiation Therapy Oncology Group
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Effect of HSD3B1 (1245C) Gene Mutation on Treatment of Stage I-III Breast Cancer
This stage IV trial examines how a mutation in HSD3B1 (1245C) gene affects treatment of stage I-III breast cancer. This trial may help researchers determine if mutations in HSD3B1 decreases the efficacy of aromatase inhibitor…
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Adenocarcinoma
- Trial name
- NCT05183828
- Testing
- Biospecimen Collection, Letrozole, Questionnaire Administration
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- University of Washington
Estrogen Receptor Positive Breast Cancer
TAK-228 Plus Tamoxifen in Patients With ER-Positive, HER2-negative Breast Cancer
This is an open label phase II clinical trial to determine the efficacy, toxicity, and safety of TAK-228 plus tamoxifen in patients with newly diagnosed ER-positive, HER2-negative breast cancer.
- Trial name
- ANETT (NCT02988986)
- Testing
- TAK-228, Tamoxifen
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- The Methodist Hospital Research Institute
Arthralgia, Breast Cancer
Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment
This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia (joint pain) caused by anastrozole or letrozole.
- Conditions
- Arthralgia, Breast Cancer, Hot Flashes, Musculoskeletal Complications
- Trial name
- NCT01573442
- Testing
- testosterone
- Where
- 529 sites in United States, Puerto Rico
- Volunteers
- 227 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Estrogen Receptor Positive, HER2/Neu Negative
Akt Inhibitor MK-2206 and Anastrozole With or Without Goserelin Acetate in Treating Patients With Stage II-III Breast Cancer
This phase II trial studies how well Akt inhibitor MK-2206 (MK-2206) and anastrozole with or without goserelin acetate works in treating patients with stage II-III breast cancer.
- Conditions
- Estrogen Receptor Positive, HER2/Neu Negative, Recurrent Breast Carcinoma, Stage IIA Breast Cancer
- Trial name
- NCT01776008
- Testing
- Akt Inhibitor MK2206, Anastrozole, Goserelin Acetate
- Where
- 8 sites in United States
- Volunteers
- 16 people
- Sponsor
- National Cancer Institute (NCI)
Estrogen Receptor Positive Breast Cancer
A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers
Some breast cancers have estrogen receptors (ER+). The investigators know that some ER+ tumours can be cured by hormone therapy alone while other ER+ breast cancers cannot.
- Trial name
- PRESTO (NCT02238808)
- Testing
- Estradiol
- Where
- Canada
- Volunteers
- 19 people
- Sponsor
- AHS Cancer Control Alberta
Ductal Carcinoma In Situ, DCIS
Omission of Adjuvant Radiotherapy in Low- and Intermediate-Risk Ductal Carcinoma In Situ After Breast-Conserving Surgery
This is a prospective, multicenter, randomized, open-label, phase III non-inferiority trial designed to evaluate whether omission of postoperative radiotherapy is clinically acceptable in patients with low- and intermediate-risk…
- Trial name
- NCT07762885
- Testing
- Adjuvant Radiotherapy, tamoxifen
- Where
- China
- Volunteers
- 636 people
- Sponsor
- Fudan University
Breast Cancer
Trastuzumab and Letrozole in Treating Postmenopausal Women With Progressive Advanced Breast Cancer
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread.
- Trial name
- NCT00238290
- Testing
- Trastuzumab + Letrozole
- Where
- 14 sites in Switzerland
- Volunteers
- 13 people
- Sponsor
- Swiss Cancer Institute
Estrogen Receptor Positive, HER2 Positive Breast Carcinoma
Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive
This randomized phase III trial studies fulvestrant and lapatinib to see how well they work compared to fulvestrant and a placebo in treating postmenopausal women with stage III or stage IV breast cancer that is hormone…
- Conditions
- Estrogen Receptor Positive, HER2 Positive Breast Carcinoma, HER2/Neu Negative, Progesterone Receptor Positive
- Trial name
- NCT00390455
- Testing
- Fulvestrant, Laboratory Biomarker Analysis, Lapatinib Ditosylate
- Where
- 368 sites in United States
- Volunteers
- 295 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Preoperative Estetrol in Breast Cancer
The study is designed as a single-center, randomized, double-blind, placebo-controlled study in pre- and postmenopausal women who will undergo surgery for breast cancer.
- Trial name
- NCT00464516
- Testing
- Estetrol
- Where
- Austria
- Volunteers
- 30 people
- Sponsor
- Pantarhei Bioscience
Bilateral Breast Carcinoma, HER2-Negative Breast Carcinoma
Testing the Addition of an Anti-cancer Drug, Berzosertib, to the Usual Treatment (Radiation Therapy) for Chemotherapy-Resistant Triple-Negative and Estrogen and/or Progesterone Receptor Positive, HER2 Negative Breast Cancer
This phase Ib trial studies the best dose of berzosertib when given together with the usual treatment (radiation therapy) in treating patients with triple negative or estrogen receptor and/or progesterone receptor positive, HER-2…
- Conditions
- Bilateral Breast Carcinoma, HER2-Negative Breast Carcinoma, Localized Breast Carcinoma, Recurrent Breast Carcinoma
- Trial name
- NCT04052555
- Testing
- Berzosertib, Biospecimen Collection, Quality-of-Life Assessment
- Where
- 14 sites in United States
- Volunteers
- 42 people
- Sponsor
- National Cancer Institute (NCI)
Advanced Breast Cancer
Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-menopausal Women
The primary objective is to evaluate whether Zoladex 10.8 mg (12-weekly) is non-inferior to Zoladex 3.6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced breast cancer by assessment of…
- Trial name
- NCT00322348
- Testing
- Goserelin acetate
- Where
- 14 sites in Czechia, Russia and 1 more
- Volunteers
- 98 people
- Sponsor
- AstraZeneca
Neoplasms, Breast
Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study
This is a randomised, open label multicenter Phase III study comparing the efficacy of neoadjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus concomitant lapatinib and trastuzumab plus paclitaxel given…
- Trial name
- Neo ALTTO (NCT00553358)
- Testing
- Lapatinib, Trastuzumab, Paclitaxel
- Where
- 121 sites in Argentina, Belgium and 22 more
- Volunteers
- 455 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Bicalutamide in Treating Patients With Metastatic Breast Cancer
RATIONALE: Androgens can cause the growth of breast cancer cells. Antihormone therapy, such as bicalutamide, may stop the adrenal glands from making androgens.
- Trial name
- NCT00468715
- Testing
- bicalutamide, diagnostic laboratory biomarker analysis, immunohistochemistry staining method
- Where
- 8 sites in United States
- Volunteers
- 28 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer, HER2-negative Breast Cancer
Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer
The purpose of this study is to learn if adding a new drug that is targeted at a specific genetic change found in some breast tumors pre-operatively will slow the growth of the tumor more than standard anti-hormone therapy used…
- Conditions
- Breast Cancer, HER2-negative Breast Cancer, ER Positive Breast Cancer
- Trial name
- NCT05101564
- Testing
- Alpelisib, Tamoxifen, Zotatifin
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Jennifer Lee Caswell-Jin
Breast Cancer
Probability of OncotypeDx to Reallocate As Low or High Risk of Recurrence Breast Cancer Patients with Uncertain Biology
In some cases of hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative early breast cancer the benefit of adding adjuvant chemotherapy to hormonal treatment, estimated on the basis of the classical…
- Trial name
- NCT06363812
- Where
- Italy
- Volunteers
- 258 people
- Sponsor
- Fondazione Sandro Pitigliani
ER-positive Breast Cancer, HER2-negative Breast Cancer
Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study)
A phase II single-arm trial of onapristone in combination with fulvestrant for women and men with ER-positive, PgR-positive or negative and HER2-negative locally advanced or metastatic breast cancer after progression on aromatase…
- Conditions
- ER-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Cancer
- Trial name
- NCT04738292
- Testing
- Onapristone, Fulvestrant
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- University of Wisconsin, Madison
Stage III Breast Cancer
[18F]FES PET/CT for the Detection of Distant Metastasis in Low-grade ER-positive Stage III Breast Cancer
This study aims to evaluate the detection rate of distant metastases using [18F]FES PET/CT in patients with low-grade, ER-positive stage III breast cancer.
- Trial name
- NCT07314073
- Testing
- Fluoroestradiol (18F)
- Where
- South Korea
- Volunteers
- 85 people
- Sponsor
- Asan Medical Center
Breast Cancer Female
Neoadjuvant Biomarker ResearcH Study of Palbociclib Combined With Endocrine Therapy in Estrogen Receptor Positive/HER2 Negative Breast CAncer (NeoRHEA)
This is an open-label, single arm, phase 2 trial that will include pre or post-menopausal female subjects, that have ER-positive, HER2-negative early breast cancer.
- Trial name
- NeoRHEA (NCT03065621)
- Testing
- Palbociclib
- Where
- 5 sites in Belgium
- Volunteers
- 100 people
- Sponsor
- Jules Bordet Institute