eligibility_summary
Eligibility: Female 18–70, ECOG 0–1, path-confirmed stage II–IIIA invasive breast cancer, HR+/HER2+, adequate hematologic/hepatic/renal function, LVEF ≥50%, contraception if childbearing, consent. Exclude: stage IV/inflammatory, prior therapy/radiation (except CIS/basal/squamous) or concurrent trial therapy, significant lung or cardiac disease, uncontrolled HTN, GI malabsorption, drug allergy or immunodeficiency/HIV/transplant, pregnant/lactating, severe comorbidities.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Darsilide (Dalcilib), an oral small-molecule CDK4/6 inhibitor, combined with letrozole (aromatase inhibitor, ± ovarian function suppression) and dual anti-HER2 therapy with trastuzumab and pertuzumab (IV or fixed-dose SC). Mechanisms: CDK4/6 inhibition prevents Rb phosphorylation, arresting G1→S cell-cycle progression, aromatase inhibition reduces estrogen synthesis to suppress ER-driven tumor growth, trastuzumab binds HER2 (domain IV) to inhibit signaling and mediate ADCC, pertuzumab binds HER2 (domain II) to block HER2/HER3 dimerization and downstream PI3K/AKT/MAPK signaling. Targets: HR+/HER2+ breast cancer cells, ER signaling, HER2/HER3 receptor pathways, CDK4/6–Rb axis, engages immune effector cells (e.g., NK cells) via Fcγ receptors for ADCC.