Actively Recruiting
The Clinical Study of the Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategy in the Treatment of Advanced Triple-negative Breast Cancer.
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-02-28
60
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective, multicenter, randomized controlled study aimed at evaluating the efficacy and safety of Trop2-ADC monotherapy or immune combination strategy in the treatment of advanced triple-negative breast cancer.
CONDITIONS
Official Title
The Clinical Study of the Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategy in the Treatment of Advanced Triple-negative Breast Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female adults aged 18 to 70 years with confirmed metastatic triple-negative breast cancer by pathology or imaging
- No more than two previous lines of therapy for metastatic disease
- ECOG performance status of 2 or lower and expected survival of at least 3 months
- At least one measurable lesion on imaging within 2 weeks before enrollment or simple bone metastases
- Prior treatment-related toxicities resolved to grade 1 or lower (except alopecia or non-safety risks) per NCI CTCAE v5.0
- Adequate bone marrow function: WBC 63.0�d710^9/L, neutrophils 61.5�d710^9/L, platelets 670�d710^9/L
- Normal liver, kidney, and heart function per lab values: total bilirubin 63x upper limit, ALT/AST 62.5x upper limit (up to 5x with liver metastases), creatinine 61.5x upper limit or clearance 60 ml/min, LVEF 65%, QTcF 6470 ms
- Understands study process and voluntarily signed informed consent
You will not qualify if you...
- Allergy to the study drug or its ingredients
- Known resistance to Trop2-ADC drugs
- Received radiotherapy, chemotherapy, or endocrine therapy within 4 weeks prior to enrollment or participating in other interventional drug trials
- Pregnant, lactating, or women of childbearing age not using effective contraception during the study
- Severe cardiac disease or conditions likely to prevent chemotherapy tolerance, including fatal arrhythmia, high-grade atrioventricular block, unstable angina, significant valvular disease, transmural myocardial infarction, or uncontrolled hypertension
- Any other condition or serious medical disorder deemed by the investigator to interfere with study participation or safety, including uncontrolled heart disease, hypertension, active infections, or active hepatitis B infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Breast Tumor Center, Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou, China;
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Z
Zhao JL Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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