Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 75Years
FEMALE
NCT06555068

A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients

Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2025-06-22

528

Participants Needed

1

Research Sites

102 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The study is being conducted to evaluate the safety, PK and efficacy of HRS-6209 in Combination with Fulvestrant, Letrozole, HRS-8080, or HRS-1358 for advanced unresectable or metastatic breast cancer

CONDITIONS

Official Title

A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 to 75 years inclusive
  • ECOG performance status score of 0 or 1
  • Histopathologically confirmed metastatic or unresectable locally advanced breast cancer that is ER-positive or PR-positive
  • Menopausal status defined by bilateral oophorectomy, age 60 or older, natural menopause with postmenopausal hormone levels, or pre/perimenopausal with LHRH agonist treatment
  • Disease progression confirmed by imaging during or after the last systemic anti-tumor treatment (for efficacy expansion stage)
  • At least one measurable extracranial target lesion at baseline per RECIST v1.1
  • Life expectancy greater than 3 months
  • Adequate organ function meeting specific blood counts, kidney, liver, heart function, and coagulation criteria
  • Female subjects of childbearing potential must use effective contraception during and for 6 months after the study and have a negative pregnancy test within 7 days before enrollment
  • Willing and able to comply with study procedures and provide informed consent
Not Eligible

You will not qualify if you...

  • Symptomatic visceral metastases unsuitable for endocrine therapy
  • Active brain metastases, carcinomatous meningitis, spinal cord compression, or history of central nervous system primary tumors
  • Clinically significant cardiovascular disease or abnormal ECG needing intervention
  • Conditions affecting oral medication absorption or metabolism
  • Clinically significant endometrial abnormalities
  • Active infection or unexplained fever above 38.5 °C at screening or first dose
  • Uncontrollable chronic systemic complications
  • Active autoimmune diseases, immunodeficiency, or history of organ transplantation
  • Acute infection or active tuberculosis requiring treatment
  • Known significant liver disease or untreated active hepatitis
  • Other malignant tumors within the past 5 years
  • Use of moderate/strong CYP3A4 inhibitors or inducers near first dose
  • Use of drugs that prolong QT/QTc interval or history of QT prolongation syndrome
  • Pregnant, lactating, or planning pregnancy during study
  • History of neural or mental disorders, psychotropic or drug abuse
  • Expected to receive other anti-tumor therapies during the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

X

Xiaoyu Zhu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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