eligibility_summary
Eligible: adults ≥18 with invasive breast cancer (T1c–T3, cN0–2, M0), low HER2 (IHC1+ or 2+/ISH–), ER/PgR ≥1%, grade G3 or G2, planned curative surgery, no prior systemic therapy, measurable disease, ECOG 0–1, adequate cardiac (NYHA<3, LVEF≥50) and organ function, contraception per protocol. Exclude: bilateral/prior BC, CIS+recent endocrine tx, recent surgery/IND/live vaccines, prior IO/ADC, transplant, serious CVD/ILD/TB/infection/autoimmune, neuro/psych, ≥G2 neuropathy, HIV/HBV/HCV/COVID, hypersensitivity, other cancer <5y.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Single-arm phase II neoadjuvant study in HR-positive, HER2-low breast cancer testing: 1) Disitamab vedotin (RC48), a HER2-directed antibody-drug conjugate delivering MMAE, binds HER2 on tumor cells, is internalized, releases MMAE to disrupt microtubules and induce apoptosis. 2) Toripalimab (JS001), an anti-PD-1 IgG4 monoclonal antibody checkpoint inhibitor that restores T-cell antitumor activity. 3) Sequential chemotherapy with epirubicin (anthracycline DNA intercalator/topoisomerase II inhibitor) and cyclophosphamide (alkylating agent causing DNA crosslinks). Target cells/pathways: HER2-expressing breast cancer cells (low HER2), microtubule polymerization, PD-1/PD-L1 immune checkpoint on T cells/tumor microenvironment, and DNA replication/repair via topo II inhibition and alkylation.