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

NCT07358182 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-01-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Trastuzumab-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.

Sponsors & Collaborators

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

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2029-06-30
Completion
2031-06-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07358182 on ClinicalTrials.gov