Clinical trials: Hormone Receptor (HR)-Positive Breast Cancer
Hormone Receptor Positive Breast Carcinoma, Breast Neoplasms
Monitoring luminAl Breast Cancer Through the Evaluation of Mutational and epiGeNEtic alteraTIons of Circulating ESR1 DNA
The purpose of the study is to determine the diagnostic role of ctDNA when used to monitor metastatic breast cancer (MBC) during first-line endocrine therapy.
- Conditions
- Hormone Receptor Positive Breast Carcinoma, Breast Neoplasms, Neoplasms, Breast, Breast Diseases
- Trial name
- MAGNETIC1 (NCT05814224)
- Testing
- Liquid biopsy and CT scan
- Where
- 7 sites in Italy
- Volunteers
- 164 people
- Sponsor
- Centro di Riferimento Oncologico - Aviano
Breast Cancer
PALbociclib CoLlaborative Adjuvant Study
This is a prospective, two arm, international, multicenter, randomized, open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR+ / HER2- early…
- Trial name
- PALLAS (NCT02513394)
- Testing
- Palbociclib, Standard Adjuvant Endocrine Therapy
- Where
- 437 sites in United States, Australia and 19 more
- Volunteers
- 5,796 people
- Sponsor
- Alliance Foundation Trials, LLC.
Metastatic Breast Cancer
A Study of Palbociclib With Exemestane Plus GnRH Versus Capecitabine in Premenopausal Women With HR+ MBC
Despite recent advances for the treatment of post-menopausal hormone receptor-positive BC, in the last decade there was no major improvement of hormonal therapy specifically for premenopausal metastatic breast cancer.
- Trial name
- NCT02592746
- Testing
- Palbociclib, Exemestane, Leuprolide Acetate
- Where
- 2 sites in South Korea
- Volunteers
- 182 people
- Sponsor
- Samsung Medical Center
Breast Cancer
Serplulimab Plus Chemotherapy for Early-stage HR+/HER2- Breast Cancer
The goal of this clinical trial is to learn if serplulimab is effective in early HR+/HER2- breast cancer. It will also learn about the safety of serplulimab.
- Trial name
- NCT06394661
- Testing
- Serplulimab+NabPE
- Where
- China
- Volunteers
- 109 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer
Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer
Dose Escalation part of the study: To estimate the MTD(s) and/ or RP2D of LEE011 in combination with everolimus + exemestane, and LEE011 in combination with exemestane, and to characterize the safety and tolerability of the…
- Trial name
- NCT01857193
- Testing
- ribociclib (LEE011), Exemestane, Everolimus (RAD001)
- Where
- 13 sites in United States, Belgium and 3 more
- Volunteers
- 132 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Efficacy and Safety of Ribociclib in Pre- and Postmenopausal Chinese Women With HR Positive, HER2-negative, Advanced Breast Cancer.
This was a randomized, double-blind, placebo-controlled study conducted in Chinese women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer, plus an open-label…
- Trial name
- NCT03671330
- Testing
- Ribociclib, NSAI: Letrozole or Anastrazole, Goserelin
- Where
- 24 sites in China
- Volunteers
- 327 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself.
A retrospective study of de-identified (to preserve patient privacy) patient information from the SEER-Medicare Database to compare overall survival of first line palbociclib + aromatase inhibitor (AI) therapy versus AI therapy…
- Trial name
- NCT06086340
- Testing
- Palbociclib, Aromatase Inhibitor
- Where
- United States
- Volunteers
- 779 people
- Sponsor
- Pfizer
Postmenopause, Breast Cancer
A Treatment With Fulvestrant and Exemestane in Postmenopausal Patients With Advanced Hormone Receptor-Positive (HR) + Breast Cancer
For patients receiving Faslodex 500 mg, to compare the effectiveness in terms of Time to Progression (TTP) as a function of the line of treatment (i.e. 1st vs. 2nd vs. 3rd line).
- Trial name
- ACT-FASTER: (NCT01171417)
- Where
- 92 sites in Germany
- Volunteers
- 570 people
- Sponsor
- AstraZeneca
Early-stage Breast Cancer, Hormone Receptor Positive Breast Carcinoma
Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer
This phase II trial investigates how well trastuzumab deruxtecan works alone or in combination with anastrozole in treating patients with HER2 low, hormone receptor positive breast cancer.
- Conditions
- Early-stage Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Invasive Breast Cancer, Stage II Breast Cancer
- Trial name
- NCT04553770
- Testing
- Anastrozole, Therapeutic Conventional Surgery, Trastuzumab Deruxtecan
- Where
- 9 sites in United States
- Volunteers
- 88 people
- Sponsor
- Jonsson Comprehensive Cancer Center
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer
This phase I trial tests the side effects and best dose of abemaciclib and niraparib in treating patients with breast cancer that is positive for estrogen or progesterone receptors (hormone receptor positive [HR+]) and HER2…
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- NCT04481113
- Testing
- Abemaciclib, Niraparib Tosylate Monohydrate
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- OHSU Knight Cancer Institute
Hormone Receptor Positive Advanced Breast Cancer
Comparative Effectiveness of PAL Based-therapy as Initial ET Versus PAL Based-therapy After ChT for HR+/HER2- ABC
A multi-center non-interventional observational study led by the Cancer Hospital Chinese Academy of Medical Sciences to compare the effectiveness of palbociclib based-therapy as initial endocrine therapy versus palbociclib…
- Trial name
- NCT05343117
- Testing
- Palbociclib based-therapy as initial endocrine therapy, Palbociclib based-therapy after chemotherapy
- Where
- 9 sites in China
- Volunteers
- 400 people
- Sponsor
- Chinese Academy of Medical Sciences
Breast Cancer
Study to Evaluate Patient Reported Outcome (PRO) and Physical Activity in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Endocrine Therapy or Endocrine Monotherapy
The study is a prospective, multicenter, observational study to evaluate PRO and physical activity using smartphone-based application and wearable device in Japanese patients with HR+/HER2- advanced breast cancer (ABC).
- Trial name
- JBCRG-26 (NCT04736576)
- Testing
- Wearable device
- Where
- 20 sites in Japan
- Volunteers
- 99 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
Roll-over Study to Allow Continued Access to Ribociclib
The purpose of this study is to assess the long-term safety of ribociclib (LEE011) in combination with other drugs and provide post-trial access (PTA) to participants who are currently receiving treatment with ribociclib in…
- Trial name
- NCT05161195
- Testing
- Ribociclib, Letrozole, Anastrozole
- Where
- 73 sites in United States, Argentina and 20 more
- Volunteers
- 134 people
- Sponsor
- Novartis Pharmaceuticals
Carcinoma, Ductal, Breast, Breast Cancer
G1T38, a CDK 4/6 Inhibitor, in Combination With Fulvestrant in Hormone Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
This is a study to investigate the potential clinical benefit of G1T38 as an oral therapy in combination with fulvestrant in patients with hormone receptor-positive, HER2-negative metastatic breast cancer.
- Conditions
- Carcinoma, Ductal, Breast, Breast Cancer, Breast Neoplasm
- Trial name
- NCT02983071
- Testing
- G1T38, Fulvestrant
- Where
- 8 sites in Bulgaria, Georgia and 2 more
- Volunteers
- 102 people
- Sponsor
- G1 Therapeutics, Inc.
Breast Cancer, Hormone-receptor Positive Breast Cancer
Pyrotinib Plus Neoadjuvant Chemotherapy in HR+/HER2-, HER4-High Breast Cancer
This is a Phase II, single-center, double-blind, placebo-controlled, randomized study of Pyrotinib in combination with Doxorubicin/Epirubicin and Cyclophosphamide followed by Docetaxel/nab-Paclitaxel as neoadjuvant therapy for…
- Trial name
- NCT04872985
- Testing
- Pyrotinib, Epirubicin, Doxorubicin Hydrochloride Liposome Injection
- Where
- China
- Volunteers
- 140 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer
Artificial Intelligence and Machine Learning to Guide CDK4/6 Inhibitor Rechallenge in Breast Cancer.
The goal of this clinical trial is to learn if an artificial intelligence model will be able to select patients with advanced breast cancer who may respond to a second cyclin-dependent kinase 4/6 (CDK4/6) inhibitor after they…
- Trial name
- AIM-BRIGHT (NCT07227233)
- Testing
- A CDK4/6 inhibitor different from the first that the participant had received, plus fulvestrant., Treatment of physician's choice
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- University of California, San Diego
Breast Cancer Invasive
NabPE With or Without Serplulimab for Early-stage HR+/HER2- Breast Cancer.
The goal of this clinical study is to learn if serplulimab is effective in early HR+/HER2- breast cancer. This trial serves a prospective parallel control cohort for HELEN-018 (NCT).
- Trial name
- NCT06781281
- Testing
- Serplulimab, NabPE
- Where
- China
- Volunteers
- 709 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer
Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer
This is a multicenter run-in phase Ib / roll-over phase II study of triple targeted drug combination (HER2-targeted small molecule inhibitor tucatinib, CDK4/6 inhibitor palbociclib and aromatase inhibitor letrozole) as a first or…
- Trial name
- NCT03054363
- Testing
- Tucatinib in Combination with Palbociclib and Letrozole
- Where
- 6 sites in United States
- Volunteers
- 42 people
- Sponsor
- University of Colorado, Denver
Brain Metastases, HR+ Metastatic Breast Cancer
SRS & Abemaciclib w/wo Imlunestrant in the Management of HR+/HER2- Breast CA Brain Metastases
This is a single arm study of abemaciclib and endocrine therapy with stereotactic radiosurgery (SRS) among patients with hormone receptor (HR)+/HER2- metastatic breast cancer brain metastases.
- Trial name
- NCT04923542
- Testing
- Stereotactic Radiosurgery (SRS), Abemaciclib, Endocrine therapy
- Where
- 2 sites in United States
- Volunteers
- 31 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Breast Cancer
Metronomic Capecitabine Plus Aromatase Inhibitor for First Line Treatment in HR(+), Her2(-) Metastatic Breast Cancer
The study is designed to compare the clinical benefit following treatment with aromatase inhibitor in combination with metronomic capecitabine versus aromatase inhibitor alone in women with hormone receptor-positive…
- Trial name
- MECCA (NCT02767661)
- Testing
- Capecitabine, Aromatase Inhibitor
- Where
- China
- Volunteers
- 263 people
- Sponsor
- Sun Yat-sen University