RecruitingNCT07358182

Efficacy and Safety of Trastuzumab-rezetecan in HER2-Expressing Breast Cancer

Efficacy and Safety of Trastuzumab-rezetecan in HER2-Positive and HER2-Low Breast Cancer: A Multicenter, Observational, Real-World Study Protocol

Sponsor

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

Enrollment

300 participants

Start Date

Jun 1, 2025

Study Type

OBSERVATIONAL

Conditions

HER2-low Breast Cancer HER2-positive Breast Cancer Trastuzumab-rezetecan

Summary

This study is a multicenter, observational, real-world investigation. The research plans to enroll 300 HER2-positive and HER2-low breast cancer patients who meet the inclusion criteria. All patients included in the analysis are currently receiving or are scheduled to receive a treatment regimen containing Trastuzumab-rezetecan. There are no restrictions on the treatment regimen, which is entirely based on the clinician's choice. The study aims to evaluate the efficacy and safety of the treatment regimen containing Trastuzumab-rezetecan. After completing screening examinations and assessments, eligible patients will enter the study treatment phase. They will receive the treatment regimen containing Trastuzumab-rezetecan and undergo follow-up visits according to the protocol. During the study treatment period, patients will undergo imaging and safety assessments as per clinical routine, with the investigator's assessment serving as the final result. Upon treatment completion or study withdrawal, corresponding safety examinations and imaging assessment data will be collected. For neoadjuvant patients, pathological complete response (pCR) will be assessed post-surgery by pathologists at the participating centers.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tracks how well a drug called trastuzumab-rezetecan works for breast cancer patients whose tumors make a protein called HER2 — either in high amounts (HER2-positive) or low amounts (HER2-low). It gathers real-world data on safety and effectiveness. **You may be eligible if...** - You are 18 or older - You have breast cancer confirmed as HER2-positive or HER2-low by lab testing - You are planned to receive trastuzumab-rezetecan as part of your treatment (before surgery, after surgery, or for advanced/metastatic disease) - If your cancer has spread, you have already tried at least one other systemic treatment - You are well enough to carry out daily activities (ECOG 0–2) - You are not pregnant and are willing to use effective contraception **You may NOT be eligible if...** - You have severe, uncontrolled health conditions such as uncontrolled high blood pressure, active bleeding, or active infection (hepatitis B, C, or HIV) - You are still recovering from side effects of a previous treatment - You have a known allergy to trastuzumab-rezetecan - You are currently in another clinical trial 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 Treatment Group

Trastuzumab-rezetecan: 4.8 mg/kg (for HER2-positive) or 6.4 mg/kg (for HER2-low) per treatment cycle of 21 days. The dosage is to be adjusted at the discretion of the investigator based on the actual clinical situation. All patients will receive treatment with a regimen containing Trastuzumab-rezetecan as determined by the investigator. The regimens for other concomitant medications will be selected by the treating physician based on the patient's individual circumstances.