RecruitingPhase 1Phase 2NCT06555068

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

An Open-Label, Multi-Center Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Patients With Advanced Unresectable or Metastatic Breast Cancer


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

528 participants

Start Date

Aug 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called HRS-6209, used in combination with other hormone-blocking medicines, for women with breast cancer that has spread or cannot be surgically removed. The cancer must be hormone receptor positive (meaning it is fueled by estrogen or progesterone). **You may be eligible if...** - You are a woman aged 18–75 - You have metastatic or locally advanced breast cancer that is ER-positive or PR-positive - You are postmenopausal, or if premenopausal, you are willing to take hormone-suppressing injections during the study - Your cancer has continued to grow during or after your last treatment - You have at least one measurable tumor outside the brain - Your heart, kidneys, liver, and blood counts are within acceptable ranges **You may NOT be eligible if...** - You have active brain metastases or fluid around your spine or brain - You have significant heart problems or abnormal heart rhythm (QT prolongation) - You have active autoimmune disease or HIV - You are pregnant, breastfeeding, or planning pregnancy - You have had another cancer in the past 5 years - You are taking certain medicines that affect drug metabolism (strong CYP3A4 inhibitors or inducers) 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.

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Interventions

DRUGHRS-6209 in Combination with Fulvestrant

HRS-6209 in Combination with Fulvestrant

DRUGHRS-6209 in Combination with HRS-1358

HRS-6209 in Combination with HRS-1358

DRUGHRS-6209 in Combination with Letrozole

HRS-6209 in Combination with Letrozole

DRUGHRS-6209 in Combination with HRS-8080

HRS-6209 in Combination with HRS-8080

DRUGHRS-6209 in Combination with HRS-1358

HRS-6209 in Combination with HRS-1358


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06555068


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