eligibility_summary
Eligible: women 18–70, ECOG 0–1, life ≥3 mo, disease‑free >6 mo, tumor tissue <3 mo old, LAR‑subtype TNBC (FUSCC), measurable recurrent/metastatic or unresectable local disease, adequate hematologic/organ function, no anticancer therapy within 3 wks and recovered, neuropathy ≤G1, contraception, consent. Exclude: recent RT/chemo/IO/major surgery (except palliative RT), cardiac disease, residual AEs, pregnancy/lactation, other recent cancers (except cured BCC/CIS), uncontrolled effusions, ILD/pneumonitis, active HBV/HCV, allergy to study drugs/monoclonals, immunodeficiency/HIV/transplant/syphilis+, or other safety concerns.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Open-label, single-arm phase II first-line therapy for locally advanced/metastatic triple‑negative breast cancer, luminal androgen receptor (LAR) subtype with HER2‑low expression. Intervention and mechanism: Trastuzumab deruxtecan (T‑DXd), an antibody‑drug conjugate (biologic anti‑HER2 IgG1 trastuzumab linked to a small‑molecule topoisomerase‑I inhibitor, DXd). It binds HER2 on tumor cells (even at low levels), is internalized, and releases DXd to inhibit TOP1, causing DNA damage and apoptosis, the membrane‑permeable payload enables bystander killing. The trastuzumab component may inhibit HER2 signaling and mediate ADCC. Targets: HER2 on TNBC‑LAR tumor cells, HER2 signaling, DNA replication/repair via TOP1, immune effector engagement through Fcγ receptors. Location: China.