Clinical trials: Estrogen Receptor Negative (ER-Negative) Breast Cancer
Breast Cancer, Metastatic Breast Cancer
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with FGF aberrant metastatic breast cancer, as well as in the treatment of patients with biomarker negative (FGF…
- Conditions
- Breast Cancer, Metastatic Breast Cancer, MBC, HER2 Positive
- Trial name
- NCT02202746
- Testing
- Lucitanib
- Where
- 33 sites in United States
- Volunteers
- 178 people
- Sponsor
- Clovis Oncology, Inc.
Breast Cancer
Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer
The purpose of this trial is to inform the future clinical development of the two investigational agents in ER+ breast cancer, LEE011 (CDK4/6 inhibitor) and BYL719 (PI3K-alpha inhibitor).
- Trial name
- NCT01872260
- Testing
- LEE011, Letrozole, BYL719
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 259 people
- Sponsor
- Novartis Pharmaceuticals
Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer
Nab-Paclitaxel and Bevacizumab Followed By Bevacizumab and Erlotinib in Metastatic Breast Cancer
This phase II trial studies how well giving paclitaxel albumin-stabilized nanoparticle (Nab-paclitaxel) formulation together with bevacizumab followed by bevacizumab and erlotinib hydrochloride work in treating patients with…
- Conditions
- Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer, Progesterone Receptor-negative Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT00733408
- Testing
- paclitaxel albumin-stabilized nanoparticle formulation, bevacizumab, erlotinib hydrochloride
- Where
- 17 sites in United States
- Volunteers
- 59 people
- Sponsor
- University of Washington
Breast Cancer
Neoadjuvant Run-In Study With TAK-228 Followed by Letrozole/TAK-228 in Women With High-Risk ER+/HER2- Breast Cancer
Millennium has developed TAK-228, which is a novel, highly selective, orally bioavailable adenosine 5' triphosphate (ATP)-competitive inhibitor of the serine/threonine kinase referred to as the mechanistic target of rapamycin…
- Trial name
- NCT02619669
- Testing
- TAK-228, Letrozole
- Where
- United States
- Sponsor
- Gary Schwartz
Breast Cancer
Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2)
Primary Objective: To assess the incidence rate of dose-limiting toxicity and to confirm the recommended dose as well as the maximum tolerated dose of SAR439859 administered as monotherapy to Japanese postmenopausal women with…
- Trial name
- AMEERA-2 (NCT03816839)
- Testing
- Amcenestrant (SAR439859)
- Where
- 3 sites in Japan
- Volunteers
- 10 people
- Sponsor
- Sanofi
Metastatic Breast Cancer
Minimally Interventional Study on Prevalence of Emerging ESR1 Mutations in Liquid Biopsy in Three Cohorts of Patients With Breast Cancer in Comparison With Patient's Baseline ESR1 Mutation Status as Defined by Tissue Profiling.
Minimally interventional study on prevalence of emerging ESR1 mutations in liquid biopsy in three cohorts of patients with breast cancer (with and without prior therapies in metastatic setting, and during first-line aromatase…
- Trial name
- Pangeia-2 (NCT06417801)
- Where
- 6 sites in Brazil
- Volunteers
- 170 people
- Sponsor
- AstraZeneca
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
Letrozole or Tamoxifen in Treating Postmenopausal Women With Breast Cancer
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen.
- Trial name
- BIG 1-98 (NCT00004205)
- Testing
- letrozole, tamoxifen citrate
- Where
- 3 sites in Denmark, France and 1 more
- Volunteers
- 8,028 people
- Sponsor
- ETOP IBCSG Partners Foundation
Breast Cancer, Estrogen Receptor Positive Tumor
Durvalumab and Endocrine Therapy in ER+/Her2- Breast Cancer After CD8+ Infiltration Effective Immune-Attractant Exposure
This is an open-label, multicentric, international, phase II trial testing aromatase inhibitors in combination with durvalumab in patients with CD8+ T cell infiltration (>10% CD8+ T cells in the tumor).
- Conditions
- Breast Cancer, Estrogen Receptor Positive Tumor, Menopause, Hormone Antagonist
- Trial name
- ULTIMATE (NCT02997995)
- Testing
- Immune-attractant, Durvalumab, Biopsy
- Where
- 29 sites in France, Spain and 1 more
- Volunteers
- 61 people
- Sponsor
- UNICANCER
Breast Cancer
Neoadjuvant Trastuzumab and Letrozole for Postmenopausal Women
The purpose of this study is to evaluate whether trastuzumab and letrozole are effective and safe in the preoperative treatment for postmenopausal patients with hormone receptor-positive and HER2-positive breast cancer.
- Trial name
- HERAKLES (NCT02214004)
- Testing
- Trastuzumab, Letrozole
- Where
- 14 sites in South Korea
- Volunteers
- 132 people
- Sponsor
- Gangnam Severance Hospital
Breast Cancer
FES (16α-[18F]-Fluoro-17β-estradiol)-PET: Towards a New Standard to Stage Locally Advanced and Recurrent, Estrogen Receptor Positive (ER+) Breast Cancer? Pilot Study to Compare [18F]FES-PET and [18F]FDG-PET
Accurate staging is of great importance in patients with clinically locally advanced primary breast cancer (LABC, stage III) or locoregional recurrent (LRR) breast cancer for making a correct treatment plan.
- Trial name
- FORESIGHT (NCT03726931)
- Testing
- 18F-Fluorestradiol PET/CT scan
- Where
- Netherlands
- Volunteers
- 40 people
- Sponsor
- Amsterdam UMC, location VUmc
Breast Cancer Stage IV, Radiotherapy
Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients
Approximately 3.5% to 6% of newly diagnosed breast cancer patients are stage IV metastatic. De novo metastatic breast cancer accounts for 20% to 25% of these cases.
- Conditions
- Breast Cancer Stage IV, Radiotherapy, Surgery
- Trial name
- PALATINE (NCT03870919)
- Testing
- Palbociclib, locoregional treatment
- Where
- 26 sites in France
- Volunteers
- 200 people
- Sponsor
- UNICANCER
Breast Cancer
Trial of RAD001 in Triple Negative Metastatic Breast Cancer
The hypothesis of this clinical research study is to discover if the study drug RAD001 can shrink or slow the growth of Estrogen Receptor/Progesterone Receptor (ER/PR) negative or Human Epidermal growth factor Receptor 2 (Her2…
- Trial name
- NCT00827567
- Testing
- RAD 001
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Milton S. Hershey Medical Center
Estrogen Receptor Negative, HER2/Neu Negative
Eribulin Mesylate and Everolimus in Treating Patients With Triple-Negative Metastatic Breast Cancer
This phase I/IB trial studies the side effects and best dose of eribulin mesylate and everolimus in treating patients with breast cancer that does not have estrogen receptors, progesterone receptors, or large amounts of human…
- Conditions
- Estrogen Receptor Negative, HER2/Neu Negative, Progesterone Receptor-negative, Stage IV Breast Cancer
- Trial name
- NCT02120469
- Testing
- everolimus, eribulin mesylate, pharmacological study
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- City of Hope Medical Center
Adult Solid Tumor, Adenocarcinoma of the Colon
Phase II Trial of the Cyclin-Dependent Kinase Inhibitor PD 0332991 in Patients With Cancer
RATIONALE: PD 0332991 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying the side effects and how well PD 0332991 works in treating patients with…
- Conditions
- Adult Solid Tumor, Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum, Adult Central Nervous System Germ Cell Tumor
- Trial name
- NCT01037790
- Testing
- PD-0332991
- Where
- United States
- Volunteers
- 304 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Breast Cancer, Other Disorders of Bone Density and Structure
Impact of Chemotherapy Followed by Aromatase Inhibitors on Bone Health of Women With ER-positive Early Breast Cancer
The purpose of this study is to identify the combined impact on bone loss as well as the incidence of bone fractures in women with estrogen receptor (ER)-positive, early breast cancer treated with an aromatase inhibitor (AI)…
- Trial name
- POCHARBI (NCT01298362)
- Testing
- Aromatase Inhibitors, Chemotherapy
- Where
- Greece
- Volunteers
- 290 people
- Sponsor
- Hellenic Breast Surgeons Society
Breast Cancer
A Phase I/II Trial to Evaluate Oral HP568 Tablets in Patients with ER+/HER2 Advanced Breast Cancer
This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety, tolerability and preliminary efficacy of HP568 alone and in combination with palbociclib in patients with ER+/HER2- locally advanced or…
- Trial name
- NCT06757335
- Testing
- HP568, HP568 in combination with palbociclib
- Volunteers
- 204 people
- Sponsor
- Hinova Pharmaceuticals Inc.
Metastatic Breast Cancer
Molecular Imaging of Fulvestrant Effects on Availability of ER Binding Sites
The dose of fulvestrant to optimally downregulate estrogen receptors (ER) is currently subject of debate. Effects of fulvestrant on the ERs may be evaluable by molecular imaging using positron emission tomography with the…
- Trial name
- NCT01377324
- Testing
- Diagnostic intervention: Positron Emission Tomography with 16-alpha-[18-fluoro]-17betaestradiol
- Where
- Netherlands
- Volunteers
- 16 people
- Sponsor
- University Medical Center Groningen
Breast Cancer
Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer
This is a randomized two arm phase II study to further evaluate the efficacy of fulvestrant plus enza compared to single agent fulvestrant in postmenopausal women with locally advanced AR+/ER+/Her2- BC who will have local surgery…
- Trial name
- NCT02955394
- Testing
- Enzalutamide, Fulvestrant
- Where
- 3 sites in United States
- Volunteers
- 61 people
- Sponsor
- University of Colorado, Denver
Advanced Breast Cancer
A Phase Ib/II Study of QLC1401 Combined With CDK4/6 or mTOR Inhibitors in ER+/HER2- Advanced Breast Cancer
This study is an open-label, multicenter, Phase Ib/II clinical trial designed to evaluate the safety, tolerability, efficacy, and pharmacokinetic characteristics of QLC1401 tablets in combination with CDK4/6 inhibitors or mTOR…
- Trial name
- NCT07173556
- Testing
- QLC1401
- Volunteers
- 96 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.