Actively Recruiting

Phase 3
Age: 18Years - 75Years
FEMALE
NCT07024173

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

Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2026-01-26

240

Participants Needed

2

Research Sites

123 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 to 75 years old (including both values)
  • ECOG Physical Strength Status (PS) of 0 to 1 point
  • Histologically confirmed locally advanced or metastatic breast cancer
  • Previously received 1 to 2 lines of endocrine therapy
  • Expected survival longer than 6 months
  • Adequate organ function
  • Voluntary participation with informed consent and agreement to follow study procedures
Not Eligible

You will not qualify if you...

  • Rapid disease progression where endocrine therapy is unsuitable or intolerable
  • History of severe clinical cardiovascular diseases
  • Uncontrollable tumor-related pain as judged by investigators
  • Severe infection within 4 weeks before study treatment
  • Clinically significant endometrial abnormalities
  • Untreated active hepatitis
  • Known allergy to HRS-8080 components
  • Pregnant or lactating women, or planning pregnancy during the study period

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510000

Actively Recruiting

2

Hunan Cancer Hospital

Changsha, Hunan, China, 410000

Actively Recruiting

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Research Team

M

Min Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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