eligibility_summary
Adults ≥18, ECOG 0–1, life ≥12 w, LA/metastatic breast cancer post-taxane with 1–2 prior regimens. TNBC (ER/PR<1%, HER2–) or HR+/HER2– (ER/PR≥1%) with prior endocrine and CDK4/6 inhibitor, measurable/evaluable disease, stable treated brain mets, adequate labs/organ function, AEs ≤G1, contraception, washout ≥2–3 w. Exclude prior topo I, leptomeningeal disease, Gilbert’s, HIV/HBV/HCV, recent major cardiac/resp/GI issues, IBD, recent infection, pregnancy/lactation, other interventional trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: PRIMED (NCT05520723), phase II, single-arm, in unresectable/metastatic TNBC. Interventions/mechanisms: • Sacituzumab govitecan (Trodelvy) – antibody–drug conjugate (ADC). Targets Trop-2 on tumor cells, internalization releases SN-38 (topoisomerase I inhibitor), causing DNA damage and tumor cell death (and bystander effect). • Loperamide – antidiarrheal, peripherally acting µ-opioid receptor agonist that reduces intestinal motility/secretion to prevent SG-induced diarrhea. • G-CSF (filgrastim) – hematopoietic growth factor binding CSF3R on myeloid progenitors to stimulate neutrophil proliferation/mobilization, preventing SG-induced neutropenia. Targets/cells: Trop-2–expressing breast cancer cells, topoisomerase I in tumor cells, enteric neurons/µ-opioid receptors (gut), bone marrow myeloid progenitors/neutrophils via CSF3R/JAK-STAT. Aim: reduce diarrhea/neutropenia to improve SG tolerance.