RecruitingPhase 2NCT07037199

Efficacy and Safety of Trastuzumab Rezetecan Followed by CDK4/6 Inhibitors and Endocrine Therapy in HR+/HER2-Low/Ultra-Low Advanced Breast Cancer

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

45 participants

Start Date

Aug 18, 2025

Study Type

INTERVENTIONAL

Conditions

Advanced Breast Cancer

Summary

This multicenter, prospective phase II clinical trial evaluates the efficacy and safety of sequential Trastuzumab rezetecan followed by dalpiciclib plus endocrine therapy (fulvestrant or aromatase inhibitors) in 45 patients with HR+/HER2-low/ultra-low advanced breast cancer. Enrolled patients will receive Trastuzumab rezetecan monotherapy for 6-8 cycles until clinical benefit, then transition to CDK4/6 inhibitors with endocrine therapy until disease progression or unacceptable toxicity. The primary endpoint is progression-free survival (PFS), with secondary endpoints including objective response rate (ORR), overall survival (OS), and treatment-related adverse events (TRAEs). The study will be conducted at Sun Yat-sen Memorial Hospital and collaborating centers.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a treatment sequence of trastuzumab rezetecan (an antibody-drug combination) followed by CDK4/6 inhibitors and hormone therapy works well for women with advanced breast cancer that is hormone receptor-positive and has low or very low levels of the HER2 protein. **You may be eligible if...** - You are a woman aged 18 or older - You have advanced or metastatic breast cancer that is hormone receptor-positive - Your cancer has low or very low HER2 levels (HER2-low or HER2-ultra-low) - Your cancer has progressed after at least one prior treatment **You may NOT be eligible if...** - Your cancer is HER2-positive (high level) - You have uncontrolled brain metastases - You have serious heart or lung conditions 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

DRUGTrastuzumab rezetecan + CDK4/6 inhibitors + endocrine therapy

sequential Trastuzumab rezetecan followed by CDK4/6 inhibitors (Dalpiciclib, Abemaciclib, Ribociclib, Palbociclib) plus endocrine therapy (fulvestrant or aromatase inhibitors)

Locations(1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

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NCT07037199

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