Clinical trials: ER Positive, HER2 Negative Breast Cancer
Metastatic Breast Cancer, Advanced Breast Cancer
Study to Evaluate the Extended Overall Survival (OS) Data From PARSIFAL Study (The PARSIFAL-LONG Study)
The goal of this study is to evaluate the extended Overall Survival (OS) from PARSIFAL trial - NCT02491983 focused on the efficacy and safety of palbociclib in combination with fulvestrant or letrozole in patients with Human…
- Conditions
- Metastatic Breast Cancer, Advanced Breast Cancer, Luminal Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT06525675
- Testing
- Fulvestrant Injectable Product, Letrozole 2.5mg, Palbociclib 125mg
- Where
- 36 sites in Czechia, France and 4 more
- Volunteers
- 419 people
- Sponsor
- MedSIR
Advanced Breast Cancer
Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer
A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a…
- Trial name
- SERENA-1b (NCT07427394)
- Testing
- Camizestrant, Atirmociclib
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Breast Cancer
Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor
The purpose of this study is to find out whether a new drug, Ipatasertib, can slow the growth of advanced breast cancer when added to standard therapy (Fulvestrant).
- Trial name
- FINER (NCT04650581)
- Testing
- Ipatasertib, Fulvestrant
- Where
- 39 sites in Australia, Canada and 1 more
- Volunteers
- 250 people
- Sponsor
- Canadian Cancer Trials Group
Breast Cancer
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2…
- Trial name
- NCT06757634
- Testing
- Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole
- Where
- 239 sites in United States, Argentina and 23 more
- Volunteers
- 1,180 people
- Sponsor
- Celcuity Inc
Breast Cancer Metastatic
Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer
Primary Objective: To determine whether amcenestrant per overall survival (os) improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic…
- Trial name
- AMEERA-3 (NCT04059484)
- Testing
- Amcenestrant, Fulvestrant, Anastrozole
- Where
- 109 sites in United States, Argentina and 21 more
- Volunteers
- 367 people
- Sponsor
- Sanofi
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
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
Durvalumab and Tremelimumab Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Stage II-III Breast Cancer
This early phase I trial studies the side effects of durvalumab and tremelimumab before surgery in treating patients with hormone receptor positive, HER2 negative stage II-III breast cancer.
- Conditions
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- Trial name
- NCT03132467
- Testing
- Durvalumab, Tremelimumab
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- M.D. Anderson Cancer Center
Advanced Estrogen Receptor Positive HER2- Breast Cancer
GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer
The primary objectives of the Phase 1b Dose Escalation part of this study are to characterize the safety and tolerability of GS-5829 in combination with exemestane or fulvestrant and to determine the maximum tolerated dose (MTD)…
- Trial name
- NCT02983604
- Testing
- GS-5829, Exemestane, Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 14 people
- Sponsor
- Gilead Sciences
ER+ Breast Cancer
Circulating Tumor DNA
This is a single-arm, phase II study examining elacestrant in the adjuvant treatment of patients with ER+ breast cancer who test positive for circulating tumor DNA (ctDNA) during the screening period of the trial.
- Trial name
- NCT06923527
- Testing
- Elacestrant
- Where
- 7 sites in United States
- Volunteers
- 50 people
- Sponsor
- Yale University
Breast Neoplasms
Study of Efficacy, Safety, and Pharmacokinetics of FCN-437c in Combination With Fulvestrant or Letrozole+Goserelin
This is a multicenter, open-label clinical study to evaluate the safety and antitumor activity of FCN-437c in combination with Fulvestrant for the treatment of post-menopausal female patients with ER+ and HER2- advanced breast…
- Trial name
- NCT05004142
- Testing
- FCN-437c+Fulvestrant, FCN-437c+Letrozole+Goserelin
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Ahon Pharmaceutical Co., Ltd.
Breast Cancer
Biological and Clinical Effects of Palbociclib With Ovarian Suppression and Letrozole in the Neoadjuvant Treatment of Breast Cancer
This study will look at the safety and effectiveness of the combination of palbociclib and letrozole and ovarian suppression for premenopausal patients who have ER-positive/HER2-negative breast cancer that has not yet been…
- Trial name
- NCT03628066
- Testing
- Letrozole, Palbociclib, Goserelin
- Where
- 15 sites in United States, Canada
- Volunteers
- 24 people
- Sponsor
- NSABP Foundation Inc
Dose Escalation, Safety
Phase Ib, Dose Escalation Study of Oral LDE225 in Combination With BKM120 in Patients With Advanced Solid Tumors
The purpose of this study is to determine the maximum dose of LDE225 and BKM120 that can be safely given together to patients and/or the dose that will be used in future studies.
- Conditions
- Dose Escalation, Safety, Preliminary Efficacy, Advanced Solid Tumors
- Trial name
- NCT01576666
- Testing
- LDE225, BKM120
- Where
- 23 sites in United States, Australia and 6 more
- Volunteers
- 120 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
DiEtary Mimicry by Glucocorticoid Modulation Evaluation in ER+ Metastatic Breast Cancer Treatment: Efficacy and Response (DEMETER Trial)
This is a single centre, open label, phase II clinical study consisting of two parts, each consisting of a different dose of the same intervention to investigate the efficacy of dexamethasone as an adjunct to endocrine therapy in…
- Trial name
- DEMETER (NCT07786051)
- Testing
- Dexamethasone (Oral)
- Volunteers
- 80 people
- Sponsor
- The Netherlands Cancer Institute
Breast Cancer
NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer
The objective of the study is to evaluate the efficacy and the safety of abemaciclib and giredestrant before surgery in participants with early stage, oestrogen receptor-positive (ER+), human epidermal receptor 2 negative (HER2-)…
- Trial name
- Neo-AGILE (NCT06259929)
- Testing
- Abemaciclib 150 MG + Giredestrant 30 MG
- Where
- 8 sites in Italy
- Volunteers
- 51 people
- Sponsor
- Fondazione Oncotech
Breast Cancer Invasive Nos
TRial on the Endocrine Activity of Neoadjuvant Degarelix
The purpose of the this study is to investigate the anti-tumor activity and tolerability of the study medications Degarelix and Triptorelin in premenopausal women receiving preoperative treatment with Letrozole.
- Trial name
- TREND (NCT02005887)
- Testing
- triptorelin, degarelix, letrozole
- Where
- 7 sites in Italy
- Volunteers
- 51 people
- Sponsor
- ETOP IBCSG Partners Foundation
Colorectal Cancer, Triple Negative Breast Cancer, NSCLC - Adenocarcinoma
A Study of PDR001 in Combination With CJM112, EGF816, Ilaris® (Canakinumab) or Mekinist® (Trametinib)
The purpose of this study was to combine the PDR001 checkpoint inhibitor with each of four agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety…
- Trial name
- NCT02900664
- Testing
- PDR001, ACZ885, CJM112
- Where
- 23 sites in United States, Belgium and 7 more
- Volunteers
- 283 people
- Sponsor
- Novartis Pharmaceuticals
Estrogen Receptor Negative, Estrogen Receptor Positive
Paclitaxel & Cyclophosphamide With or Without Trastuzumab Before Surgery in Treating Previously Untreated Breast Cancer
This phase II trial studies the side effects and how well giving paclitaxel and cyclophosphamide with or without trastuzumab before surgery works in treating patients with previously untreated breast cancer.
- Conditions
- Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, HER2/Neu Positive
- Trial name
- NCT01750073
- Testing
- Cyclophosphamide, Doxorubicin Hydrochloride, Laboratory Biomarker Analysis
- Where
- 4 sites in United States
- Volunteers
- 92 people
- Sponsor
- University of Nebraska
Androgen Receptor Positive, Estrogen Receptor Negative
Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cancer
This phase II trial studies the side effects and how well pembrolizumab and enobosarm work in treating patients with androgen receptor positive triple negative breast cancer that has spread to other places in the body…
- Conditions
- Androgen Receptor Positive, Estrogen Receptor Negative, HER2/Neu Negative, Metastatic Triple-Negative Breast Carcinoma
- Trial name
- NCT02971761
- Testing
- Enobosarm, Laboratory Biomarker Analysis, Pembrolizumab
- Where
- 7 sites in United States
- Volunteers
- 18 people
- Sponsor
- City of Hope Medical Center
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.
Breast Adenocarcinoma, Estrogen Receptor Negative
Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer
This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer.
- Conditions
- Breast Adenocarcinoma, Estrogen Receptor Negative, HER2/Neu Negative, Progesterone Receptor Negative
- Trial name
- NCT02488967
- Testing
- Carboplatin, Cyclophosphamide, Doxorubicin Hydrochloride
- Where
- 1,296 sites in United States, Canada
- Volunteers
- 782 people
- Sponsor
- NRG Oncology