Clinical trials: HR+ HER2- Breast Cancer
Breast Cancer
Treatment Landscape and Real-World Dosing Patterns With CDK4/6 Inhibitors for Breast Cancer in Portugal
Assess and characterize the real-world cyclin-dependent kinase 4/6 inhibitor (CDKI) use in advanced/metastatic breast cancer (a/mBC), evaluate treatment persistence, and quantify CDKI dose adjustments in Portugal.
- Trial name
- PORTRAIT (NCT07223476)
- Where
- United States
- Volunteers
- 1,926 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer
A Study of XZP-3287 in Combination With Fulvestrant in Patients With Advanced Breast Cancer
This is a phase III clinical trial to evaluate the efficacy and safety of XZP-3287 in combination with Fulvestrant versus placebo combined with Fulvestrant in Patients who have HR positive and Her2 negative recurrent/metastatic…
- Trial name
- NCT05077449
- Testing
- XZP-3287+Fulvestrant
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
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
Neoplasms, Breast Neoplasms
Study to Evaluate the Safety and Antitumor Activity of CX-2009 Monotherapy and in Combination With CX-072 in Advanced Breast Cancer
A Phase 2, clinical study in advanced, metastatic breast cancer that will evaluate CX-2009 monotherapy in both Hormone Receptor(HR) positive/HER2 negative breast cancer and in TNBC, and evaluate CX-2009+CX-072 in TNBC
- Conditions
- Neoplasms, Breast Neoplasms, Breast Neoplasms, Triple-Negative, Breast Cancer
- Trial name
- NCT04596150
- Testing
- CX-2009, CX-072
- Where
- 42 sites in United States, South Korea and 1 more
- Volunteers
- 125 people
- Sponsor
- CytomX Therapeutics
Breast Cancer
Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer
This is a Phase III, randomized, double-blind, parallel, multi-center trail to evaluate the efficacy and safety of TQB3616 capsule combined with endocrine compared to placebo compared with endocrine in HR-positive and…
- Trial name
- NCT05780567
- Testing
- TQB3616 capsules, Letrozole, Anastrozole, Tamoxifen
- Where
- 3 sites in China
- Volunteers
- 1,946 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Breast Cancer
Ribociclib Real-world Treatment Patterns and Clinical Outcomes Among Women With HR+/HER2- Advanced or Metastatic Breast Cancer in France
This study is a national, multicenter, prospective, non-interventional study in women with HR+/HER2- locally advanced or metastatic breast cancer (BC), for which a prior clinical decision to initiate ribociclib + endocrine…
- Trial name
- RosaLEE (NCT05697146)
- Testing
- ribociclib + ET
- Where
- 82 sites in France
- Volunteers
- 1,019 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer
Treatment Patterns & Clinical Outcomes of Palbociclib Combinations in HR+HER2-MBC
The objective of this non-interventional multicenter study is to provide prospective, observational data on patients initiating treatment with palbociclib combination to contribute to the knowledge of HR+ HER2-metastatic/locally…
- Trial name
- PRECIOUS (NCT04937660)
- Where
- 12 sites in Egypt, Jordan and 3 more
- Volunteers
- 185 people
- Sponsor
- Pfizer
Breast Cancer, Advanced Solid Tumor
A Phase I Study of RGT-419B in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer or Other Solid Tumors
This is a Phase 1 dose escalation and dose expansion phase I study to evaluate the safety, tolerability, pharmacokinetic profile and preliminary efficacy of RGT-419B as monotherapy in Chinese patients with HR+/HER2…
- Trial name
- NCT06299124
- Testing
- RGT-419B
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Regor Pharmaceuticals Inc.
Breast Cancer
Safety Extension Study for Subjects With HR+, HER2- Breast Cancer for Subjects Who Have Completed the OVELIA Study
TOL2506A (OVELIA) is a Phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 in suppressing ovarian function in premenopausal women with HR+, HER2-negative breast cancer and men with HR+ breast cancer.
- Trial name
- NCT05645536
- Testing
- TOL2506, Tamoxifen, Letrozole tablets
- Where
- 46 sites in United States, Argentina and 4 more
- Volunteers
- 250 people
- Sponsor
- Tolmar Inc.
Breast Cancer
A Study to Learn About the Relationship Between Hepatic Impairment and Myelosuppression (Decreased Bone Marrow Function) in Breast Cancer Patients Treated With the Study Medicine Palbociclib (Pal-bow-sai-klib)
The purpose of this study is to evaluate incidence of grade 4 neutropenia in patients who have hepatic impairment and use the study medicine Palbociclib.This study is seeking participants: - treated with the study medicine…
- Trial name
- NCT05912933
- Where
- United States
- Volunteers
- 1,342 people
- Sponsor
- Pfizer
Advanced Breast Cancer
Study of CYH33 in Combination With Endocrine Therapy With or Without Palbociclib in Patients With HR+, HER2- Advanced Breast Cancer
This is a multicenter, open-label, phase Ib study designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of CYH33 administered orally in combination with standard-of-care ET ± CDK4/6 inhibitor…
- Trial name
- NCT04856371
- Testing
- CYH33, Fulvestrant, Letrozole
- Volunteers
- 228 people
- Sponsor
- Haihe Biopharma Co., Ltd.
Early Breast Cancer
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free…
- Trial name
- Adjuvant WIDER (NCT05827081)
- Testing
- Ribociclib, Letrozole, Ansastrozole
- Where
- 214 sites in United States, Argentina and 14 more
- Volunteers
- 1,466 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Ovarian Suppression Evaluating Subcutaneous Leuprolide Acetate in Breast Cancer
This is a phase 3, single arm, open-label study evaluating the effectiveness of TOL2506 to suppress ovarian function in premenopausal women with HR+, HER2-negative breast cancer.
- Trial name
- OVELIA (NCT04906395)
- Testing
- TOL2506, Tamoxifen, Letrozole Tablets
- Where
- 59 sites in United States, Argentina and 5 more
- Volunteers
- 250 people
- Sponsor
- Tolmar Inc.
Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
This is a multicenter, open-label, Phase Ib/II randomized study designed to evaluate the safety, tolerability, dose-limiting toxicities (DLTs), and preliminary antitumor activity of JSKN016 in combination with the oral selective…
- Trial name
- NCT07336771
- Testing
- JSKN016 Q2W, JSKN016 Q3W, D-0502
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Breast Cancer
A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment
This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer…
- Trial name
- RIBANNA (NCT06311383)
- Testing
- First-line Ribociclib + endocrine therapy, First-line endocrine therapy, First-line chemtherapy
- Where
- 265 sites in Germany
- Volunteers
- 2,610 people
- Sponsor
- Novartis Pharmaceuticals
Locally Advanced or Metastatic Breast Cancer
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC
This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive…
- Trial name
- NCT06439771
- Testing
- YL202 should be intravenously infused
- Where
- China
- Volunteers
- 180 people
- Sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
Breast Cancer Metastatic
Treatment Patterns And Clinical Outcomes Among Patients in Latin America Receiving First Line Palbociclib Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In Real World Settings.
To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments as first line therapy, regardless of combination…
- Trial name
- NCT05155566
- Where
- 2 sites in Argentina, United Kingdom
- Volunteers
- 847 people
- Sponsor
- Pfizer
Breast Cancer Metastatic
A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study
The purpose of this study is to find out the possible anti-cancer effect of pelareorep in combination with chemotherapy [paclitaxel] and avelumab in treating a type of breast cancer called Hormone Receptor positive (HR+)/Human…
- Trial name
- NCT04215146
- Testing
- Paclitaxel, Pelareorep, Avelumab
- Where
- 18 sites in United States
- Volunteers
- 48 people
- Sponsor
- Oncolytics Biotech
Advanced Breast Cancer, Advanced or Metastatic Breast Cancer
A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08165784) when given alone or together with other anti-cancer therapies.
- Conditions
- Advanced Breast Cancer, Advanced or Metastatic Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07897721
- Testing
- PF-08165784, Fulvestrant, Atirmociclib
- Volunteers
- 268 people
- Sponsor
- Pfizer
Advanced Breast Cancer, Metastatic Breast Cancer
T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd
This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to…
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer, HER2 Positive, HR Positive
- Trial name
- DB-Guide (NCT07683754)
- Testing
- Trastuzumab deruxtecan, Trastuzumab, Pertuzumab
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- Daiichi Sankyo