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The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis

NCT07203729 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2026-03-16

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if Trastuzumab Rezetecan (SHR-A1811) is safe and tolerable for patients with HER2-Low unresectable/metastatic breast cancer complicated with visceral crisis. Participants will take Trastuzumab Rezetecan every three weeks, until disease progression or intolerable toxicity.

Conditions

  • HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis

Interventions

DRUG

Trastuzumab Rezetecan

Trastuzumab Rezetecan 4.8mg/kg, IV, Day 1, Q3W

DRUG

Chemotherapy of Physician's Choice

Chemotherapy of Physician's Choice, including nab-paclitaxel, Eribulin, Capecitabine, Vinorelbine, Gemcitabine.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2030-06-15
Completion
2030-12-30

Countries

  • China

Study Locations

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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 NCT07203729 on ClinicalTrials.gov