eligibility_summary
Eligible: adults (≥18) with HER2+ unresectable/metastatic breast cancer, measurable disease, prior taxane, trastuzumab, and T-DXd, washouts (≥14 d tx, ≥7 d RT/WBRT/SRS), resolved toxicities, ECOG 0–2, LVEF ≥50%, adequate organ/marrow, treated brain mets off steroids ≥7 d, ER/PR known, consent and tissue/biopsy. Exclude: prior Trop‑2 ADC, allergy to trastuzumab/sacituzumab, UGT1A128 homozygotes, active brain/LM disease, recent major surgery, second malignancy, uncontrolled illness, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
SATEEN (NCT06100874): single-arm phase II in HER2+ metastatic breast cancer after trastuzumab deruxtecan. Interventions: sacituzumab govitecan (Trodelvy), a Trop-2–directed antibody-drug conjugate that delivers SN-38 (topoisomerase I inhibitor), plus trastuzumab (IV or SC Hylecta/biosimilar), a humanized IgG1 monoclonal antibody to HER2. Mechanisms: SG binds Trop-2 on tumor cells → internalization and release of SN-38 causing topo I–mediated DNA damage and bystander effect. Trastuzumab blocks HER2/ERBB2 signaling and dimerization and mediates antibody-dependent cellular cytotoxicity (ADCC) via NK cells. Targets/pathways: Trop-2 on breast cancer cells, HER2-driven MAPK and PI3K–AKT pathways, topoisomerase I in proliferating tumor cells. Hyaluronidase-oysk facilitates SC trastuzumab absorption.