Clinical trials: Hormone Receptor-Positive Breast Carcinoma
Breast Cancer
Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women
To evaluate the antitumor activity, toxicity, and effectiveness of the combination of goserelin (Zoladex) and anastrozole (Arimidex) in the treatment of premenopausal women with hormone receptor positive metastatic carcinoma of…
- Trial name
- NCT00186121
- Testing
- Anastrozole (Arimidex), Goserelin (Zoladex)
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Stanford University
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 (Locally Advanced or Metastatic), Advanced Solid Cancers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Advanced/Metastatic Breast Cancer or Locally Advanced/Metastatic Solid Tumor
This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-6452 in adult patients with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2…
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers, Metastatic (Stage IV) Breast Cancer, Ovarian Cancer
- Trial name
- NCT07612891
- Testing
- INV-6452
- Where
- China
- Volunteers
- 201 people
- Sponsor
- Shenzhen Ionova Life Sciences Co., Ltd.
Brest Cancer, CDK4/6 Inhibitor
Effectiveness and Safety of Palbociclib: Brand vs. Generic in Iraqi Stage IV Breast Cancer Patients
This study aims to evaluate the efficacy and safety of branded palbociclib (Ibrance®) compared to available local generic formulations (Palbociclib-IPI) in Iraqi patients with hormone receptor-positive, human epidermal growth…
- Trial name
- PALLAS-IRAQ (NCT07493291)
- Testing
- Palbociclib (Brand vs Generic) compartive
- Where
- Iraq
- Volunteers
- 100 people
- Sponsor
- Al-Mustansiriyah University
Breast Cancer
Targeting the PAM50 Her2-Enriched Phenotype With Enzalutamide in Hormone Receptor-Positive/Her2-Negative Metastatic BC
The main hypothesis of the study is that enzalutamide induces a significant proliferative arrest in HR+/HER2-negative breast cancer falling into the PAM50 HER2-E subtype.
- Trial name
- ARIANNA (NCT04142060)
- Testing
- Enzalutamide
- Where
- 8 sites in Spain
- Volunteers
- 34 people
- Sponsor
- SOLTI Breast Cancer Research Group
Metastatic Breast Cancer
A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs.
- Trial name
- BELLE-3 (NCT01633060)
- Testing
- Fulvestrant, BKM120
- Where
- 197 sites in United States, Argentina and 20 more
- Volunteers
- 432 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
PET/CT Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer
Purpose: To determine whether [18F]FES can predict clinical benefit (defined as complete response, partial response and stable disease ≥ 6 months) to fulvestrant (250 mg IM q 28 days) in post-menopausal women with recurrent or…
- Trial name
- NCT00816582
- Testing
- Diagnostic Imaging: 18F-FDG PET/CT Scan - Baseline, Diagnostic Imaging: 18F-FES PET/CT - Baseline, Diagnostic Imaging: 18F-FES PET/CT - 3 month follow-up
- Where
- 4 sites in Canada
- Volunteers
- 17 people
- Sponsor
- British Columbia Cancer Agency
Breast Cancer
Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer
Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined with Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor-Resistant, HR-Positive, HER2-Negative…
- Trial name
- NCT06702618
- Testing
- TQB3616 capsule+Fulvestrant Injection
- Where
- 13 sites in China
- Volunteers
- 33 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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
Breast Cancer
Sac-TMT Plus KL-A167 in PD-L1+, HR+/HER2- Metastatic Breast Cancer After CDK4/6 Inhibitors
This is a Phase II single-arm study designed to evaluate the efficacy and safety of Sac-TMT + KL-A167 in 35 patients with PD-L1+, HR+/HER2- metastatic breast cancer who previously treated with CDK4/6 inhibitor.
- Trial name
- NCT07258108
- Testing
- Lucanisatuzumab plus tagolimumab
- Where
- China
- Volunteers
- 35 people
- Sponsor
- Sun Yat-sen University
Breast Cancer
Breast Cancer Study of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment
The study is being conducted to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) combined neoadjuvant treatment for patients with triple-negative and hormone receptor-positive, HER2-negative breast…
- Trial name
- NCT05132790
- Testing
- SHR-1316 at a dose 20mg/kg q3w, SHR6390 at a dose of 150mg orally, daily, SBRT
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Shengjing Hospital
Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer
Comparing Endocrine Therapy Combined With High-Dose Palbociclib and Hydroxychloroquine to Endocrine Therapy Combined With Standard-Dose Palbociclib for Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer
This is a a phase III, randomized, open-label clinical trial comparing endocrine therapy combined with high-dose palbociclib and hydroxychloroquine to endocrine therapy combined with standard-dose palbociclib for hormone…
- Trial name
- NCT07061717
- Testing
- Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd, Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid, Palbociclib 200mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid
- Where
- China
- Volunteers
- 474 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer
This early phase I trial tests whether letrozole with simvastatin works better than letrozole alone to stop tumor cell proliferation in patients with stage I-III hormone receptor positive, HER2 negative invasive breast cancer.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma
- Trial name
- NCT05464810
- Testing
- Letrozole, Simvastatin
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Emory University
Breast Cancer
Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative…
- Trial name
- monarchE (NCT03155997)
- Testing
- Abemaciclib, Standard Adjuvant Endocrine Therapy
- Where
- 619 sites in United States, Argentina and 36 more
- Volunteers
- 5,637 people
- Sponsor
- Eli Lilly and Company
Estrogen Receptor-positive Breast Cancer, Recurrent Breast Cancer
Tipifarnib and Fulvestrant in Hormone Receptor-Positive Metastatic Breast Cancer
This phase II trial is studying how well giving tipifarnib together with fulvestrant works as second-line therapy in treating postmenopausal women with hormone receptor-positive inoperable locally advanced or metastatic breast…
- Conditions
- Estrogen Receptor-positive Breast Cancer, Recurrent Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Trial name
- NCT00082810
- Testing
- fulvestrant, tipifarnib
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- National Cancer Institute (NCI)
Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases
This phase I/II trial studies the best dose and effect of pimasertib in combination with bintrafusp alfa in treating patients with cancer that has spread to the brain (brain metastases).
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Hematopoietic and Lymphoid Cell Neoplasm, Hormone Receptor Positive Breast Adenocarcinoma
- Trial name
- NCT04789668
- Testing
- Bintrafusp Alfa, Pimasertib, Quality-of-Life Assessment
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer, Metastatic Breast Cancer
Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
The purpose of this research study is to see if the medication sacituzumab govitecan (SG) is effective at the currently approved dose and schedule in people who have previously received trastuzumab deruxtecan (T-DXd) for the…
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Hormone-receptor-positive Breast Cancer
- Trial name
- SERIES (NCT06263543)
- Testing
- Sacituzumab govitecan
- Where
- 3 sites in United States
- Volunteers
- 75 people
- Sponsor
- Reshma L. Mahtani, D.O.
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Evaluation of Alternative Site Goserelin Acetate Injection for Ovarian Function Suppression (OFS) in Local and Locally Advanced Premenopausal Hormone Receptor Positive Breast Cancer Patients
This phase II trial determines if giving goserelin acetate injections in the upper gluteal region is as effective for ovarian function suppression (OFS) as giving injections in the abdomen for ovarian function suppression (OFS)…
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Locally Advanced Hormone Receptor-Positive Breast Carcinoma
- Trial name
- NCT07460752
- Testing
- Biospecimen Collection, Goserelin Acetate, Questionnaire Administration
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- Mayo Clinic
Breast Cancer, Arthralgia
Observational Study to Evaluate Mechanisms of Aromatase Inhibitor Associated Musculoskeletal Symptoms
Early stage hormone receptor positive breast cancer is typically treated with adjuvant endocrine therapy in order to decrease risk of breast cancer recurrence and to improve overall survival from the disease.
- Trial name
- NCT02118636
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Lynn Henry
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.