eligibility_summary
Patients with confirmed TNBC (ER/PR <1%, HER2−), prior taxane, eligible for ICC chemo (eribulin/capecitabine/gemcitabine/vinorelbine), measurable disease (not skin/bone‑only), ECOG 0–1, ≥3‑mo survival, adequate organs, prior toxicities ≤1, tissue available, contraception. Exclude other malignancy <5y, symptomatic CNS mets, significant pulmonary/IBD/GI issues, Gilbert/UGT1A128, HIV/HBV/HCV, prior TROP‑2/topo‑I, recent therapy/vaccine/surgery/steroids, substance abuse, pregnancy, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 TNBC trial comparing FDA018-ADC (antibody–drug conjugate) vs single-agent chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine). FDA018-ADC: an ADC that binds a tumor cell-surface antigen and, after internalization, releases a cytotoxic payload, based on exclusions (no prior TROP-2–targeted or topoisomerase I–containing therapy), it is likely a TROP-2–directed, topo I–payload ADC. Targets/pathways: TROP-2–expressing TNBC cells, DNA damage via topoisomerase I inhibition. Comparators: eribulin (halichondrin analog, microtubule dynamics/mitotic spindle), capecitabine (oral 5-FU prodrug, thymidylate synthase/DNA synthesis), gemcitabine (deoxycytidine analog, ribonucleotide reductase and DNA replication), vinorelbine (vinca alkaloid, microtubule polymerization).