A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer
Interventional
Phase 3
Sun Yat-sen University Cancer Center
Sponsor: Shandong Suncadia Medicine
Last Updated: January 26, 2026 Notice- Information is sourced from public registries and may not reflect real-time changes at the local site.
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.
1. Women aged 18 to 75 years old (including both values).
2. ECOG Physical Strength Status (PS) : 0 to 1 point.
3. Patients with locally advanced or metastatic breast cancer confirmed by histology.
4. Patients previously received 1-2 lines of endocrine therapy.
5. Expected survival > 6 months.
6. The functional level of the organs must meet the requirements.
7. Subjects that voluntarily participate in this clinical trial, be willing and able to abide by the procedures related to clinical visits and research, understand the research procedures and have signed the informed consent.
Exclusion Criteria
1. Patients with rapid disease progress and investigators determine that endocrine therapy is not suitable or tolerant.
2. A history of severe clinical cardiovascular diseases.
3. Patients with uncontrollable tumor-related pain as judged by investigators.
4. Severe infection exists within 4 weeks before the first study administration.
5. Patients with clinically significant endometrial abnormalities.
6. Untreated active hepatitis.
7. Patients known to be allergic to HRS-8080 components.
8. Pregnant and lactating women, or those planning to become pregnant during the study period.
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Design Details
AllocationRandomized
Intervention ModelParallel Assignment
MaskingNone (Open Label)
Number to Enroll240
Arms & Interventions
Arms
Interventions
Type: Experimental
Description:
Interventions:
HRS-8080 Tablet
Fulvestrant injection
Exemestane tablets
Everolimus Tablets
Anastrozole Tablets
Letrozole Tablets
Outcome Measures
Primary Outcome Measures
Progression free survival (PFS) evaluated by the blinded independent central review (BICR).Approximately 2 years.
Secondary Outcome Measures
Overall response rate (ORR).Approximately 2 years.
Clinical benefit rate (CBR).Approximately 2 years.
Duration of response (DOR).Approximately 2 years.
Overall survival (OS).Approximately 3 years.
Adverse events (AEs).Approximately 2 years.
Serious adverse events (SAEs).Approximately 2 years.
Progression free survival (PFS) evaluated by investigators.Approximately 2 years.