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

Launched by SHANDONG SUNCADIA MEDICINE CO., LTD. · Jun 9, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HRS-8080 for women with locally advanced or metastatic breast cancer, which means the cancer has spread beyond the breast or is difficult to remove with surgery. The study will compare HRS-8080 to the usual treatments that doctors currently choose. The goal is to see if HRS-8080 works better or has fewer side effects than standard therapies.

Women between the ages of 18 and 75 who have breast cancer confirmed by a biopsy and have already tried 1 or 2 hormone treatments may be eligible to join. Participants should be in generally good health with a good level of physical activity and expect to live more than six months. The trial is not yet recruiting, but if you join, you will be closely monitored through regular visits to the clinic. Women who have serious heart problems, active infections, untreated liver disease, or who are pregnant or breastfeeding will not be able to participate. If you’re interested, you would need to understand the study and agree to follow the study procedures by signing a consent form.

Gender

FEMALE

Eligibility criteria

• 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.