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

Phase 3

Recruiting

• Conditions: Locally Advanced Breast Cancer; Metastatic Breast Cancer
• Interventions: Drug: HRS-8080 Tablet; Drug: Fulvestrant injection; Drug: Exemestane tablets; Drug: Everolimus Tablets

• Registration Number: NCT07024173
• Lead Sponsor: Shandong Suncadia Medicine Co., Ltd.

Brief Summary

This study is a multicenter, open-label, randomized controlled, Phase 3 clinical trial.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-09
• Study First Submitted QC: 2025-06-09
• Study First Posted: 2025-06-17
• Status Verified: 2025-07
• Study Start: 2025-07-23
• Last Update Submitted: 2025-07-29
• Last Update Posted: 2025-07-31
• Primary Completion: 2026-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HRS-8080 Group	HRS-8080 Tablet	-
Fulvestrant Group	Fulvestrant injection	-
Exemestane in combination with Everolimus Group	Exemestane tablets	-
Exemestane in combination with Everolimus Group	Everolimus Tablets	-

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS) evaluated by investigators.	Approximately 2 years.

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS) evaluated by the blinded independent central review (BICR).	Approximately 2 years.
Clinical benefit rate (CBR).	Approximately 2 years.
Overall survival (OS).	Approximately 3 years.
Duration of response (DOR).	Approximately 2 years.
Overall response rate (ORR).	Approximately 2 years.
Adverse events (AEs).	Approximately 2 years.
Serious adverse events (SAEs).	Approximately 2 years.

Trial Locations

Locations (2)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

Hunan Cancer Hospital; 🇨🇳 Changsha, Hunan, China