A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer
NCT07024173 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2026-01-26
Summary
This study is a multicenter, open-label, randomized controlled Phase 3 clinical trial. It is planned to enroll 240 female patients with locally advanced or metastatic breast cancer followed by disease progression after previous endocrine therapy.
Conditions
- Locally Advanced Breast Cancer
- Metastatic Breast Cancer
Interventions
- DRUG
-
HRS-8080 Tablet
HRS-8080 tablet orally administered.
- DRUG
-
Fulvestrant injection
Fulvestrant injection.
- DRUG
-
Exemestane tablets
Exemestane tablets orally administered.
- DRUG
-
Everolimus Tablets
Everolimus tablets orally administered.
- DRUG
-
Anastrozole Tablets
Anastrozole tablets orally administered.
- DRUG
-
Letrozole Tablets
Letrozole tablets orally administered.
Sponsors & Collaborators
-
Shandong Suncadia Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-23
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
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