NCT07024173

A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer

A Multicenter, Open-label, Randomized Controlled Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer With Disease Progression After Previous Endocrine Therapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Shandong Suncadia Medicine Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-07-23
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2025-06-17
• Last updated: 2026-01-26

Locations

2 sites across 1 country: China