RecruitingPhase 3NCT07349069

A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer

A Randomized, Open-Label, Phase III Trial to Compare HRS-8080 Versus Standard Endocrine Therapy in Patients With Intermediate or High Risk Early Breast Cancer Who Have Received at Least 2 Years of Standard Adjuvant Endocrine Therapy


Sponsor

Shandong Suncadia Medicine Co., Ltd.

Enrollment

5,500 participants

Start Date

Mar 4, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with intermediate or high risk early breast cancer.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether HRS-8080, a new hormone-blocking drug, is better than standard hormone therapy at preventing early-stage ER-positive, HER2-negative breast cancer from coming back after surgery. **You may be eligible if...** - You are a woman between 18 and 75 years old with Stage II–III breast cancer - Your cancer was confirmed as ER+/HER2- by pathology - You have already received 2–5 years of adjuvant hormone therapy - You have no evidence of cancer recurrence or spread - You have adequate organ function and an ECOG performance status of 0 or 1 - You are willing to use non-hormonal contraception if you are of childbearing potential **You may NOT be eligible if...** - Your cancer has spread to other parts of the body (Stage IV) - You have a history of another cancer within the past 5 years - You have severe lung disease or interstitial lung disease - You are HIV-positive or have certain other medical conditions 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGHRS-8080 Tablets

HRS-8080 tablets.

DRUGLetrozole tablets

Letrozole tablets.

DRUGTamoxifen Citrate Tablets

Tamoxifen Citrate tablets.

DRUGAnastrozole Tablets

Anastrozole tablets.

DRUGExemestane tablets

Exemestane tablets.


Locations(2)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07349069


Related Trials