eligibility_summary
Adults (≥18) of any gender with ER/PR‑negative or ≤10% positive, HER2‑negative primary invasive breast cancer, unilateral target lesion, stage I (cT1a‑cN0) or select stage II not fit for neoadjuvant polychemo, M0, ECOG 0–1/KI≥80, normal LVEF/ECG, adequate labs, tumor block, consent/contraception. Exclude: hypersensitivity, recent malignancy, prior invasive breast Ca, prior cytotoxics/other trials, pregnancy/breastfeeding, noncompliance, neuropathy≥2, major comorbidity/infection/pneumonitis, active HBV/HCV/HIV.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Sacituzumab govitecan (SG, Trodelvy) vs SG + pembrolizumab (Keytruda). Drug types and mechanisms: • SG is an antibody–drug conjugate (ADC) that targets Trop-2 on tumor cells and delivers SN-38 (active metabolite of irinotecan), a topoisomerase I inhibitor. Binding/internalization leads to SN-38 release, DNA damage, and tumor cell death, cleavable linker allows a bystander effect. • Pembrolizumab is a monoclonal antibody immune checkpoint inhibitor that blocks PD-1 on T cells, reversing PD-1/PD-L1–mediated T-cell inhibition and enhancing antitumor immunity. Cells/pathways targeted: • Trop-2–expressing triple-negative breast cancer cells, topoisomerase I/DNA replication machinery. • PD-1/PD-L1 checkpoint in the tumor microenvironment, restoring CD8+ effector T-cell function. Setting: neoadjuvant therapy for low-risk early TNBC.