eligibility_summary
Eligibility: ≥18, Stage II/III primary invasive TNBC or HR‑low/HER2‑negative, ECOG 0–1, tumor sample, adequate marrow/organ function, contraception per protocol. Exclude: prior invasive breast cancer, recent other cancer, autoimmune/inflammatory disease, distant disease, corneal disease, active HBV/HCV, uncontrolled HIV, active infections/TB, QTcF>470, significant cardiac/pulmonary disease or ILD, prior therapy for this cancer, pregnancy/breastfeeding, HRT or oral hormonal contraception.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase III neoadjuvant/adjuvant trial in early TNBC or HR-low/HER2− breast cancer. Experimental: datopotamab deruxtecan (Dato‑DXd, anti‑TROP2 antibody–drug conjugate delivering a topoisomerase‑I inhibitor) + durvalumab (anti‑PD‑L1 mAb), adjuvant durvalumab ± chemotherapy. Comparator: pembrolizumab (anti‑PD‑1 mAb) + standard chemotherapy, adjuvant pembrolizumab ± chemotherapy. Optional: olaparib (PARP inhibitor) for gBRCA+ residual disease, capecitabine (oral 5‑FU prodrug), doxorubicin/epirubicin (anthracycline topo‑II inhibitors), cyclophosphamide (alkylator), paclitaxel (microtubule stabilizer), carboplatin (DNA cross‑linking platinum). Targets/pathways: TROP2‑positive tumor cells, DNA damage/repair (Topo‑I/II, PARP, platinum, alkylation), microtubules, PD‑1/PD‑L1 immune checkpoint to activate cytotoxic T‑cell responses.