eligibility_summary
Eligible: ≥18, stage I–III breast cancer post neoadjuvant chemo+surgery and post‑neoadjuvant ±RT, non‑pCR (TNBC/HER2+: ≠ypT0/is ypN0, HR+/HER2–: CPS‑EG ≥3 & N0 or ≥2 & N+), ECOG 0–1, adequate organ function, contraception. MTB‑based arms by biomarkers: PD‑L1/MSI/TMB/CD274, PIK3CA, PI3K‑AKT (non‑PIK3CA, HR+), BRCA/PALB2, TROP‑2, HER2 mut/ex20ins. Exclude: recent malignancy, active HBV/HCV/HIV/TB, unresolved ≥G2 tox, recent tx/surgery, pregnancy, GI issues, serious comorbidity, prohibited meds.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
COGNITION-GUIDE (NCT05332561) is a genomics-guided, 7-arm, post‑neoadjuvant umbrella trial in high‑risk early breast cancer. Molecular profiling assigns patients to: 1) Atezolizumab—anti‑PD‑L1 monoclonal antibody checkpoint inhibitor, restores T‑cell antitumor activity by blocking PD‑1/PD‑L1 immune evasion (targets PD‑L1+ tumors, MSI‑H/TMB‑H/CD274 amp). 2) Inavolisib—oral PI3K‑α–selective small‑molecule inhibitor, blocks PIK3CA‑mutant PI3K/AKT signaling. 3) Ipatasertib—oral pan‑AKT small‑molecule inhibitor, suppresses AKT in PI3K‑AKT–activated tumors. 4) Olaparib—oral PARP inhibitor, exploits HRD in BRCA1/2 or PALB2‑mutant cells (DNA‑repair pathway). 5) Sacituzumab govitecan—anti‑TROP‑2 antibody–drug conjugate delivering SN‑38 (topoisomerase I inhibitor) to TROP‑2+ tumor cells. 6) Trastuzumab + pertuzumab—anti‑HER2 monoclonal antibodies, dual ERBB2 blockade/ADCC for activating HER2 mutations/exon‑20 insertions. 7) Observation.