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RECRUITING
NCT07349069
PHASE3

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

Sponsor: Shandong Suncadia Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

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

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

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

4800

Start Date

2026-03-04

Completion Date

2034-01

Last Updated

2026-03-19

Healthy Volunteers

No

Conditions

Interventions

DRUG

HRS-8080 Tablets

HRS-8080 tablets.

DRUG

Letrozole tablets

Letrozole tablets.

DRUG

Tamoxifen Citrate Tablets

Tamoxifen Citrate tablets.

Locations (2)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China