ctDNA-guided Treatment Decision-making
Study on ctDNA-guided Treatment Decision-making for HER2-negative Metastatic Breast Cancer
Sponsor: Fudan University
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Progression-Free Survival (PFS) in TNBC (Group A vs Group B)
Time frame: From randomization until progression or death (up to 36 months)
Secondary Endpoints
ORR (RECIST v1.1)，DoR，CBR，OS，Safety (CTCAE v5.0)
Eligibility Criteria
Inclusion Criteria: * Age 18-75 years；ECOG performance status 0-1； Histologically or cytologically confirmed HER2-negative metastatic breast cancer； At least one measurable lesion per RECIST v1.1； Eligible for ADC therapy； Adequate organ and bone marrow function； Life expectancy ≥3 months； Willingness to provide tumor tissue and blood samples； Signed informed consent Exclusion Criteria: * Prior treatment with ADC targeting the same antigen and payload；History of grade ≥3 immune-related adverse events； Active or untreated CNS metastases； Active autoimmune disease requiring systemic therapy； Clinically significant cardiovascular disease； Active interstitial lung disease； Active infection including tuberculosis, HIV, hepatitis B or C； Pregnancy or breastfeeding；Investigator-determined conditions that may interfere with study participation
✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
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