eligibility_summary
Adults 18–80 with histologically proven invasive breast cancer (luminal/HER2/TN) and oligometastasis (≤3 lesions, each ≤3 cm, brain ≤2 cm, asymptomatic), no other distant mets, all lesions amenable to surgery/radiation, specific bone mets limits. ECOG 0–1, adequate organs, LVEF>50%, consent, no prior metastasis therapy, DFI ≥12 mo if recurrent. Secondary: post-planned systemic therapy, no progression, residual treatable lesion. Exclude active cancer, infection/fever, pregnancy, chronic steroids, major cardiac/pulmonary disease, uncontrolled HTN/DM, HBsAg+.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06135714 (OLIGAMI) tests adding metastasis-directed therapy (MDT: SBRT/conventional RT or surgery) to ongoing systemic therapy vs systemic therapy alone in oligometastatic breast cancer. Interventions and mechanisms: • Luminal: CDK4/6 inhibitors (small-molecule cell-cycle blockers of CDK4/6–Rb) with endocrine therapy—aromatase inhibitors (lower estrogen, small molecules), fulvestrant (SERD, ER degradation), plus LHRH agonists (ovarian suppression). • HER2+: trastuzumab (anti‑HER2 mAb, signaling blockade/ADCC) + pertuzumab (anti‑HER2 mAb, dimerization blockade) + taxane (microtubule stabilizer). • TNBC PD‑L1+: pembrolizumab (anti‑PD‑1 mAb) + gemcitabine (antimetabolite) + carboplatin (DNA crosslinker) or atezolizumab (anti‑PD‑L1 mAb) + nab‑paclitaxel (microtubule). • TNBC PD‑L1−: taxane or S‑1/capecitabine (5‑FU prodrugs, TS inhibition) or eribulin (microtubule dynamics inhibitor). • BRCA+: olaparib (PARP1/2 inhibitor, synthetic lethality). Targets/pathways: ER signaling, CDK4/6‑Rb, HER2/ERBB2→PI3K/AKT/MAPK, microtubules, DNA synthesis/repair (TS, crosslinks, PARP/BER), PD‑1/PD‑L1 on T cells, RT induces DNA DSBs and immunogenic cell death in metastases.