RecruitingPhase 1Phase 2NCT06974929

A Clinical Study of HRS-6209 Combined With Other Treatment Regimens in Patients With Breast Cancer

An Open-Label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 Combination Therapy in Patients With Breast Cancer


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

80 participants

Start Date

May 22, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HRS-6209 combined with other treatment regimens in breast cancer patients, and preliminarily observe its anti-tumor efficacy.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing HRS-6209 — a new targeted drug — in combination with other cancer treatments in women with breast cancer that has stopped responding to prior therapies. **You may be eligible if...** - You are a woman between 18 and 75 years old - You have breast cancer with evidence of progression on imaging after your most recent treatment - You have at least one measurable tumor outside the brain - Your estimated survival is more than 3 months - Your physical performance score is ECOG 0–1 - You use effective contraception if you are of childbearing potential **You may NOT be eligible if...** - You have uncontrolled brain metastases - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding - You cannot tolerate the study medications based on prior reactions 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 Capsules

Oral HRS-6209 capsules.

DRUGLetrozole Tablets

Oral Letrozole tablets.

DRUGHRS-2189 Tablets

HRS-2189 tablets.


Locations(1)

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

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NCT06974929


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