eligibility_summary
Eligible: women ≥18 with histologically confirmed TNBC, unresectable locally advanced or recurrent/metastatic disease, progressed after ≥1 prior line, ≥1 measurable lesion (RECIST 1.1), adequate organ function, ECOG 0–1, life ≥3 mo, no RT/targeted/surgery ≤3 wks, ≤G1 neuropathy, contraception, consent. Exclude: recent chemo/immuno/RT (bisphosphonates allowed), uncontrolled CNS mets, significant cardiac disease, unresolved ≥G1 toxicities (except alopecia), major surgery ≤3 wks, pregnant/lactating, other malignancy ≤5 yrs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, open-label platform trial in refractory metastatic TNBC stratified by molecular subtype (IM, BLIS, LAR, MES) and HER2 status (HER2-low vs HER2-0). Interventions: SHR-A1811 (anti-HER2 antibody–drug conjugate) and a TROP2-targeting ADC, given alone or combined with camrelizumab (anti–PD-1 monoclonal antibody) or BP102 (bevacizumab-biosimilar anti-VEGF mAb). Mechanisms: ADCs bind HER2 or TROP2 on tumor cells to deliver cytotoxic payloads, PD-1 blockade reactivates T-cell antitumor immunity, VEGF inhibition suppresses tumor angiogenesis and may improve drug/immune infiltration. Targets/pathways: HER2 and TROP2 on TNBC cells, PD-1/PD-L1 immune checkpoint on T cells, VEGF/VEGFR signaling in tumor vasculature. Aim: subtype-guided precision therapy.