Clinical trials: HR Positive
Advanced Metastatic Breast Cancer
Study for Women and Men With Hormone-receptor Positive Locally Advanced or Metastatic Breast Cancer
This was a national, multi-center, open-label, phase IIIb trial to determine the efficacy and safety of treatment with ribociclib (LEE011) plus letrozole in patients with HR+, HER2-negative advanced (recurrent or metastatic)…
- Trial name
- NCT03096847
- Testing
- ribociclib, letrozole, goserelin
- Where
- 84 sites in Germany
- Volunteers
- 502 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
- Trial name
- MONALEESA-3 (NCT02422615)
- Testing
- Ribociclib, Fulvestrant
- Where
- 174 sites in United States, Australia and 28 more
- Volunteers
- 726 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
The purpose of this clinical trial is to study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2-negative advanced breast cancer on first-line treatment with ribociclib and letrozole and…
- Trial name
- BioItaLEE (NCT03439046)
- Testing
- Ribociclib, Letrozole, Alpelisib
- Where
- 41 sites in Italy
- Volunteers
- 287 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms
A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer
The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery.
- Trial name
- eMonarcHER (NCT04752332)
- Testing
- Abemaciclib, Standard Adjuvant ET
- Where
- 115 sites in United States, Argentina and 18 more
- Volunteers
- 111 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity
This was a phase III, randomized, double blind, multicenter, 2-arm study evaluating the efficacy and safety of amcenestrant compared with tamoxifen in participants with hormone receptor-positive early breast cancer who…
- Trial name
- AMEERA-6 (NCT05128773)
- Testing
- Amcenestrant, Tamoxifen
- Where
- 2 sites in Chile, China
- Volunteers
- 3 people
- Sponsor
- Sanofi
Early Breast Cancer
A Pharmacodynamics Pre-surgical Study of LEE011 in Early Breast Cancer Patients (MONALEESA-1)
This is a multi-center, open-label Phase II randomized pre-surgical pharmacodynamics study.
- Trial name
- MONALEESA-1 (NCT01919229)
- Testing
- LEE011 (ribociclib), letrozole
- Where
- 7 sites in United States, Singapore and 1 more
- Volunteers
- 14 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
Advanced or Metastatic Breast Cancer
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast…
- Trial name
- DB-06 (NCT04494425)
- Testing
- Trastuzumab deruxtecan, Capecitabine, Paclitaxel
- Where
- 293 sites in United States, Argentina and 26 more
- Volunteers
- 866 people
- Sponsor
- AstraZeneca
Advanced Metastatic Breast Cancer
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a…
- Trial name
- MONALEESA-7 (NCT02278120)
- Testing
- Ribociclib, Tamoxifen, Letrozole
- Where
- 183 sites in United States, Argentina and 28 more
- Volunteers
- 672 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
This is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based…
- Trial name
- NCT04460898
- Where
- United States
- Volunteers
- 195 people
- Sponsor
- Pfizer
Breast Cancer
A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib
This study was a companion study to CLEE011A2404 which provided the opportunity for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.
- Trial name
- NCT03050398
- Testing
- Ribociclib, letrozole
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Hormone Receptor Positive Tumor
Aromatase Inhibitor and Durvalumab in Postmenopausal Breast Cancer
This study is to find out if an investigational drug called Durvalumab (MEDI4736) given together with a standard of care aromatase inhibitor drug can help people with breast cancer.
- Trial name
- NCT03874325
- Testing
- Durvalumab, Anastrozole 1mg, Letrozole 2.5mg
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Locally Advanced or Metastatic Malignant Solid Tumors
A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1.
- Trial name
- NCT04225117
- Testing
- enfortumab vedotin, pembrolizumab
- Where
- 39 sites in United States, Canada and 1 more
- Volunteers
- 329 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Breast Cancer
Fulvestrant (Faslodex) + Anastrozole (Arimidex) vs Anastrozole
Postmenopausal women with hormone receptor positive and negative Her2 tumours. Before randomization, the patients will be stratified according to the center, positive nodes (0 vs. 1-3 vs.
- Trial name
- NCT00543127
- Testing
- Fulvestrant, Anastrozole
- Where
- 53 sites in Spain
- Volunteers
- 870 people
- Sponsor
- Spanish Breast Cancer Research Group
Hematologic Diseases, Acute Myelogenous Leukemia
Ondansetron Versus Aprepitant Plus Ondansetron for Emesis
The goal of this clinical research study is to compare the effectiveness of receiving a combination of ondansetron and aprepitant to receiving ondansetron alone in helping to prevent nausea and/or vomiting in patients with Acute…
- Conditions
- Hematologic Diseases, Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Chronic Myelogenous Leukemia
- Trial name
- NCT00954941
- Testing
- Ondansetron, Aprepitant
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer
A Study of HR+/HER2- Metastatic Breast Cancer Patients Treated With Palbociclib Together With an Aromatase Inhibitor From 2017 to 2023 in Denmark.
The purpose of this study is to describe the effect of the medicine palbociclib when given together with an aromatase inhibitor for treatment of breast cancer.
- Trial name
- NCT06307457
- Testing
- Palbociclib in combination with AI
- Where
- Denmark
- Volunteers
- 604 people
- Sponsor
- Pfizer
Breast Cancer
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
To determine whether treatment with alpelisib plus fulvestrant prolonged progression-free survival (PFS) compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), human epidermal…
- Trial name
- SOLAR-1 (NCT02437318)
- Testing
- Fulvestrant, Alpelisib
- Where
- 197 sites in United States, Argentina and 29 more
- Volunteers
- 572 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal…
- Trial name
- NCT05384119
- Testing
- TTI-101, Palbociclib, Aromatase inhibitor (AI)
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Tvardi Therapeutics, Incorporated
Breast Cancer
A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer
The researcher are doing this study to find out whether benralizumab is effective at preventing skin rashes caused by alpelisib in people who have metastatic breast cancer. Skin rash is a common side effect of alpelisib.
- Trial name
- NCT05966584
- Testing
- Benralizumab, fulvestrant or AIs) and PI3K inhibition (alpelisib)
- Where
- 7 sites in United States
- Volunteers
- 1 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Locally Advanced (Inoperable) or Metastatic Breast Cancer
Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer
Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer…
- Trial name
- CAPItello-291 (NCT04305496)
- Testing
- Fulvestrant, Capivasertib
- Where
- 215 sites in United States, Argentina and 17 more
- Volunteers
- 818 people
- Sponsor
- AstraZeneca