eligibility_summary
Eligible: females ≥18 with HR+ HER2- metastatic breast cancer, prior AI or tamoxifen (±CDK4/6), elevated CA15-3/CA27-29/CEA, measurable disease, ECOG 0–1, adequate organ function, negative pregnancy test/contraception, consent/compliance. Exclude: prior fulvestrant, drug allergy, CNS mets, recent investigational therapy, other recent cancers, uncontrolled illness/visceral crisis, HIV, active TB/HBV/HCV, recent immunosuppression, pregnancy/breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 pilot in HR+ HER2− metastatic breast cancer using sequential “first‑strike/second‑strike” therapy. Sequence: 1) Docetaxel (taxane microtubule stabilizer, cytotoxic) + Cyclophosphamide (alkylating agent, DNA crosslinker) ± GM‑CSF (cytokine stimulating granulocyte-macrophage lineage, may enhance antigen presentation). 2) Antibody-drug conjugate: Sacituzumab govitecan (anti–Trop-2 ADC delivering SN-38, topoisomerase I inhibitor) or Trastuzumab deruxtecan (anti-HER2 ADC delivering DXd, topoisomerase I inhibitor). 3) Capecitabine (oral 5-FU prodrug, antimetabolite inhibiting thymidylate synthase). 4) Fulvestrant (SERD, estrogen receptor degrader) + Ribociclib or Abemaciclib (CDK4/6 inhibitors causing G1/S arrest). Targets/pathways: microtubules, DNA damage and pyrimidine synthesis, Trop-2/HER2-expressing tumor cells, estrogen receptor signaling, CDK4/6–Rb cell-cycle axis, myeloid/immune pathways (GM-CSF).