Actively Recruiting
The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-03-16
184
Participants Needed
1
Research Sites
252 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Efficacy and Safety of Trastuzumab Rezetecan (SHR-A1811) in HER2-Low Unresectable/Metastatic Breast Cancer Patients With Visceral Crisis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years
- Pathologically confirmed HER2-Low unresectable or metastatic breast cancer
- Presence of visceral crisis defined by severe organ dysfunction due to rapid cancer progression
- Indication for single-agent chemotherapy as determined by investigators
- Adequate bone marrow function: neutrophil count ≥ 1,500/mm³, platelet count ≥ 80 × 10^9/L, hemoglobin ≥ 80 g/L
- Received no more than 1 line of chemotherapy for advanced disease
- Received endocrine therapy in the advanced stage permitted
- Previous treatment with CDK4/6 inhibitors permitted
- Previous or concurrent local treatment for symptom relief permitted
- Negative serum pregnancy test within 7 days before first dose for premenopausal or non-sterilized females
- Willingness to use effective contraception during study and for 1 year after last dose
- Voluntary participation with informed consent, good compliance, and willingness to follow up
You will not qualify if you...
- Prior treatment with new antibody-drug conjugates (ADCs) at any breast cancer stage
- Unsuitability for systemic chemotherapy as judged by investigator
- Other malignant tumors within past 5 years except certain cured skin or cervical cancers
- Major surgery or significant trauma within 4 weeks before randomization or planned major surgery
- Severe heart diseases including heart failure with LVEF < 50%, high-risk angina, arrhythmias, significant valve disease, ECG signs of myocardial infarction, or uncontrolled hypertension
- Known allergy to study drug components
- History of immunodeficiency, including HIV, or other immune disorders
- History of allogeneic organ or stem cell transplantation
- History of psychotropic substance abuse or drug addiction
- Pregnancy or lactation, or unwillingness to use effective contraception during study and for 7 months after last dose
- Severe comorbid diseases or conditions interfering with treatment, such as active hepatitis B or pulmonary infection requiring treatment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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