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

NCT07349069 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5500

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

HRS-8080 Tablets

HRS-8080 tablets.

DRUG

Letrozole tablets

Letrozole tablets.

DRUG

Tamoxifen Citrate Tablets

Tamoxifen Citrate tablets.

DRUG

Anastrozole Tablets

Anastrozole tablets.

DRUG

Exemestane tablets

Exemestane tablets.

Sponsors & Collaborators

  • Shandong Suncadia Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-04
Primary Completion
2030-12-31
Completion
2034-01-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07349069 on ClinicalTrials.gov