Clinical trials: Metastatic Hormone Receptor Positive Breast Cancer
Hormone Receptor Positive HER-2 Negative Breast Cancer
A Phase II Study to Evaluate the Efficacy and Safety of HLX43 in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
This is a Phase II Study of HLX43 in Hormone Receptor Positive,HER-2 negative Locally Advanced or Metastatic Breast Cancer Patients with Disease Progression on Standard of Care.
- Trial name
- NCT07459738
- Testing
- HLX43
- Volunteers
- 60 people
- Sponsor
- Shanghai Henlius Biotech
PIK3CA Mutation, HER2- Negative Breast Cancer
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with…
- Conditions
- PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer
- Trial name
- ReDiscover-2 (NCT06982521)
- Testing
- Zovegalisib, Capivasertib, Fulvestrant
- Where
- 243 sites in United States, Argentina and 25 more
- Volunteers
- 540 people
- Sponsor
- Relay Therapeutics, Inc.
Advanced, Metastatic Breast Cancer
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2…
- Trial name
- MONALEESA-2 (NCT01958021)
- Testing
- Ribociclib, Letrozole
- Where
- 221 sites in United States, Argentina and 27 more
- Volunteers
- 668 people
- Sponsor
- Novartis Pharmaceuticals
Locoregionally Recurrent Hormone-receptor Positive Breast Cancer, Metastatic Hormone Receptor Positive Breast Cancer
A Phase 1 Study of 68Ga-R11228 and 177Lu-R11228 in Breast Cancer
A phase 1 study of 68Ga-R11228 and 177Lu-R11228 in breast cancer.
- Trial name
- NCT07121244
- Testing
- 68Ga-R11228, 177Lu-R11228
- Where
- 7 sites in United States, Australia
- Volunteers
- 11 people
- Sponsor
- Radionetics Oncology
Hormone Receptor Positive Breast Cancer, Metastatic Breast Cancer
CDK4/6-inhibitor or Chemotherapy, in Combination with ENDOcrine Therapy, for Advanced Breast Cancer / KENDO
Prospective, open label, multicenter, group sequential response adaptive randomized phase 2 study, comparing two treatments for locally advanced or metastatic luminal breast cancer: Arm A: concomitant cyclin-dependent Kinase 4/6…
- Conditions
- Hormone Receptor Positive Breast Cancer, Metastatic Breast Cancer, Hormone Receptor Negative Breast Cancer
- Trial name
- KENDO (NCT03227328)
- Testing
- concomitant cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor plus endocrine therapy, chemotherapy plus endocrine therapy (administered either concomitantly or sequentially)
- Where
- 20 sites in Italy
- Volunteers
- 52 people
- Sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Breast Neoplasms
Fulvestrant (F)+Placebo vs F+Palbociclib First Line for Postmenopausal Hormone Receptor+ Advanced Breast Cancer
This is an international, multicentre, double-blind, controlled, randomized phase II study comparing the efficacy and safety of fulvestrant in combination with palbociclib versus fulvestrant plus placebo in postmenopausal women…
- Trial name
- FLIPPER (NCT02690480)
- Testing
- PD-0332991 (Palbociclib), Fulvestrant
- Where
- 32 sites in Ireland, Spain
- Volunteers
- 189 people
- Sponsor
- Spanish Breast Cancer Research Group
Neoplasms, Breast
A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer
A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).
- Trial name
- NCT01160211
- Testing
- Lapatinib, Trastuzumab, Aromatase Inhibitor
- Where
- 110 sites in United States, Argentina and 27 more
- Volunteers
- 369 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Hormone Receptor Positive Tumor
Dose EScalation Induction of EvERolimus
The BOLERO-2 study demonstrated a benefit for patients who received everolimus in addition to exemestane in patients who progressed during/after a non-steroidal aromatase inhibitor; Routine use of everolimus shows an high rate of…
- Trial name
- Desiree (NCT02387099)
- Testing
- 3 weeks Dose Induction of Everolimus, 3 weeks Conventional Everolimus Dosing, Open Label Phase with conventional 10mg Everolimus Dosing week 4-24
- Where
- 14 sites in Germany
- Volunteers
- 156 people
- Sponsor
- GBG Forschungs GmbH
Metastatic Breast Cancer
A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer
The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2…
- Trial name
- Next MONARCH 1 (NCT02747004)
- Testing
- Abemaciclib, Tamoxifen, Prophylactic Loperamide
- Where
- 59 sites in United States, Argentina and 12 more
- Volunteers
- 234 people
- Sponsor
- Eli Lilly and Company
ER-Positive HER2-Negative Breast Cancer
A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone…
- Trial name
- SERENA-4 (NCT04711252)
- Testing
- AZD9833, Anastrozole, Palbociclib
- Where
- 263 sites in United States, Austria and 25 more
- Volunteers
- 1,371 people
- Sponsor
- AstraZeneca
Estrogen Receptor-positive Breast Cancer, Progesterone Receptor-positive Breast Cancer
Anastrozole and ZD1839 Compared With Fulvestrant and ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer
This randomized phase II trial is studying how well giving gefitinib together with anastrozole works compared to giving gefitinib together with fulvestrant in treating postmenopausal women with recurrent or metastatic breast…
- Conditions
- Estrogen Receptor-positive Breast Cancer, Progesterone Receptor-positive Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
- Trial name
- NCT00057941
- Testing
- anastrozole, gefitinib, fulvestrant
- Where
- United States
- Volunteers
- 148 people
- Sponsor
- National Cancer Institute (NCI)
HR+/HER2-negative Breast Cancer
A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer
The goal of this clinical trial is to evaluate the safety and efficacy of TOS-358 in women with HR+ HER2- metastatic breast cancer whose tumors have a mutation in PIK3CA and who meet all other study enrollment criteria.
- Trial name
- NCT05683418
- Testing
- TOS-358, Fulvestrant, Palbociclib
- Where
- 18 sites in United States, Spain
- Volunteers
- 241 people
- Sponsor
- Totus Medicines
Breast Neoplasms, Pancreatic Neoplasms
Safety Study of Nivolumab With Nab-Paclitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, Nab-Paclitaxel / Carboplatin in Stage IIIB/IV Non-Small Cell Lung Cancer or Nab-Paclitaxel in Recurrent Metastatic Breast Cancer
The purpose of this study is to assess safety of nab-paclitaxel based chemotherapy regimens administered prior to and/or in combination with nivolumab in Pancreatic Cancer, Non Small Cell Lung Cancer (NSCLC) and Metastatic Breast…
- Trial name
- NCT02309177
- Testing
- nab-Paclitaxel, Nivolumab, Gemcitabine
- Where
- 15 sites in United States
- Volunteers
- 114 people
- Sponsor
- Celgene
Breast Cancer
Pembrolizumab and Paclitaxel in Hormone Receptor-positive, hyperMUTATted Metastatic Breast Cancer Identified by Whole exOme sequeNcing ('MUTATION2')
Abbreviated Title :Pembrolizumab with paclitaxel in hypermutated breast cancer Trial Phase: Phase II Clinical Indication: Hormone receptor-positive metastatic breast cancer Trial Type: Interventional Type of control: None Route…
- Trial name
- NCT04946227
- Testing
- Pembrolizumab 200mg +Paclitaxel 80mg/m2
- Where
- South Korea
- Volunteers
- 52 people
- Sponsor
- Yonsei University
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
Anatomic Stage IV Breast Cancer AJCC v8, Hormone Receptor Positive Breast Carcinoma
Abemaciclib and Endocrine Therapy in Older Patients With Breast Cancer.
This phase IIa trial studies the side effects of abemaciclib monotherapy in treating patients age 70 years and older with hormone receptor positive, HER2 negative breast cancer that has spread to other places in the body.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Hormone Receptor Positive Breast Carcinoma, Metastatic Breast Carcinoma, Prognostic Stage IV Breast Cancer AJCC v8
- Trial name
- NCT04305834
- Testing
- Abemaciclib, Questionnaire Administration
- Where
- 6 sites in United States
- Volunteers
- 43 people
- Sponsor
- City of Hope Medical Center
Breast Cancer
Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen at Least 2nd Line in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer
A single-site study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine therapy, in metastatic breast cancer patients with HR-positive \& HER2-negative after capecitabine-base chemotherapy.
- Trial name
- NCT03204734
- Testing
- Capecitabine, endocrine therapy
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Zhejiang Cancer Hospital
Advanced Malignant Solid Neoplasm, Estrogen Receptor Positive
Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients
This phase I trial studies the side effects and best dose of everolimus and trastuzumab when given together with letrozole in treating patients with hormone receptor-positive and human epidermal growth factor (EGF) receptor 2…
- Conditions
- Advanced Malignant Solid Neoplasm, Estrogen Receptor Positive, HER2/Neu Positive, Postmenopausal
- Trial name
- NCT02152943
- Testing
- Everolimus, Laboratory Biomarker Analysis, Letrozole
- Where
- 5 sites in United States
- Volunteers
- 37 people
- Sponsor
- M.D. Anderson Cancer Center
Metastatic Breast Cancer
ZK 230211 in Postmenopausal Woman With Metastatic Breast Cancer
Randomized phase II study to investigate the efficacy, safety and tolerability of ZK 230211 (100 mg vs. 25 mg) as second-line endocrine therapy for postmenopausal women with hormone receptor-positive metastatic breast cancer.Once…
- Trial name
- NCT00555919
- Testing
- Lonaprisan (ZK 230211, BAY86-5044)
- Where
- 28 sites in Austria, Finland and 8 more
- Volunteers
- 68 people
- Sponsor
- Bayer
Breast Cancer Female, HER2-positive Breast Cancer
Pyrotinib Combined With Trastuzumab and AI in the First-line Treatment of HER2 Positive/ HR Positive MBC
This study is a randomized, open-label, phase II study, comparing the efficacy and safety of trastuzumab plus aromatase inhibitors, with or without pyrotinib, in the treatment of HR (hormone receptor)+/HER2 (human epidermal…
- Conditions
- Breast Cancer Female, HER2-positive Breast Cancer, Hormone Receptor Positive Malignant Neoplasm of Breast, Metastatic Breast Cancer
- Trial name
- Pyrotinib (NCT03910712)
- Testing
- Pyrotinib, Trastuzumab, Aromatase inhibitor
- Volunteers
- 250 people
- Sponsor
- Peking Union Medical College Hospital