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Clinical Trials in China / NCT07024173
Recruiting Phase 3

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

NCT07024173 · tracked via the Priya Life Science China tracker
Sponsor
Shandong Suncadia Medicine Co., Ltd.
Phase
Phase 3
Started
2025-07-23
Last updated
2026-01-26

Condition(s) studied

Locally Advanced Breast CancerMetastatic Breast Cancer

Investigational drug(s) / intervention(s)

HRS-8080 Tablet →Fulvestrant injection →Exemestane tablets →Everolimus Tablets →Anastrozole Tablets →Letrozole Tablets →

HRS-8080 Tablet: HRS-8080 tablet orally administered.

Fulvestrant injection: Fulvestrant injection.

Exemestane tablets: Exemestane tablets orally administered.

Everolimus Tablets: Everolimus tablets orally administered.

Anastrozole Tablets: Anastrozole tablets orally administered.

Letrozole Tablets: Letrozole tablets orally administered.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Sun Yat-sen University Cancer Center Guangzhou Guangdong Recruiting
Hunan Cancer Hospital Changsha Hunan Recruiting

More Shandong Suncadia Medicine Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07024173 on ClinicalTrials.gov ↗ ← All trials in China