RecruitingPhase 2NCT07203729

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

Trastuzumab Rezetecan (SHR-A1811) Versus Chemotherapy of Physician's Choice in Patients With HER2-Low Unresectable/Metastatic Breast Cancer Complicated With Visceral Crisis:A Randomized, Prospective, Open-Label Phase II Trial.


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

184 participants

Start Date

Mar 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a targeted antibody drug called trastuzumab rezetecan (SHR-A1811) in people with HER2-low metastatic breast cancer who are experiencing a visceral crisis — meaning the cancer is progressing rapidly and causing serious problems in vital organs like the liver or lungs. This situation typically requires more aggressive and immediate treatment. **You may be eligible if...** - You are 18–75 years old with metastatic breast cancer classified as HER2-low - You are currently experiencing a visceral crisis (rapidly worsening organ function, such as rising bilirubin, worsening breathlessness, or other organ compromise) - Your doctors believe you need single-agent chemotherapy - You have received no more than 1 prior chemotherapy regimen for metastatic disease - Your blood counts and organ function meet required levels **You may NOT be eligible if...** - Your breast cancer is HER2-positive (not HER2-low) - You have had more than 1 line of chemotherapy for metastatic disease - You have uncontrolled brain metastases - You are pregnant or breastfeeding - You have severe heart problems or other major organ failure 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

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

DRUGChemotherapy of Physician's Choice

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


Locations(1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

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NCT07203729