RecruitingPhase 3NCT07024173

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


Sponsor

Shandong Suncadia Medicine Co., Ltd.

Enrollment

240 participants

Start Date

Jul 23, 2025

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study is testing a new hormone therapy drug called HRS-8080 compared to treatments chosen by the physician in women with locally advanced or metastatic breast cancer that is hormone receptor-positive. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have locally advanced or metastatic breast cancer confirmed by biopsy - You have already received 1 to 2 lines of hormonal therapy - You are in good physical condition (ECOG 0–1) - Your life expectancy is greater than 6 months - Your organ function (blood, liver, kidneys) is adequate **You may NOT be eligible if...** - Your disease is progressing so quickly that hormone therapy is not appropriate - You have serious heart disease - You have uncontrolled cancer-related pain - You have an active serious infection or active hepatitis - You have significant uterine lining abnormalities - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHRS-8080 Tablet

HRS-8080 tablet orally administered.

DRUGFulvestrant injection

Fulvestrant injection.

DRUGExemestane tablets

Exemestane tablets orally administered.

DRUGEverolimus Tablets

Everolimus tablets orally administered.

DRUGAnastrozole Tablets

Anastrozole tablets orally administered.

DRUGLetrozole Tablets

Letrozole tablets orally administered.


Locations(2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Hunan Cancer Hospital

Changsha, Hunan, China

View Full Details on ClinicalTrials.gov

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NCT07024173


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