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Life sciences · Phase 3 Trial
ClinicalTrials.gov · October 7, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT06135714). This is a study registration, not published results. Lead sponsor: Tokyo Medical and Dental University. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 146 participants (ESTIMATED). Conditions: Breast Cancer, Oligometastasis, Metastatic Breast Cancer. Interventions: DRUG: Systemic therapy for 12 weeks after primary registration; PROCEDURE: Radiation therapy (SBRT/conventional RT); PROCEDURE: Surgery; DRUG: Same systemic therapy after secondary registration. Primary outcome measures: Overall survival after second registration , 5 years. Brief summary: OLIGAMI trial is a multi-institutional, two-arm, open-label, randomized controlled phase III trial being conducted with the participation of 50 hospitals belonging to Japan Clinical Oncology Group. After the first registration, all patients will be performed in a 12-week, subtype-specific, systemic therapy consisting of CDK4/6 inhibitors with hormonal therapy for luminal BC, docetaxel with trastuzumab and pertuzumab for HER2-positive BC, chemotherapy with immune checkpoint inhibitors for triple-negativeBC expressing PD-L1, and olaparib for cases harboring BRCA mutations. For other triple-negative BC, chemotherapy will be administered. If this 12-week systemic therapy does not cause any progression or complete response, patients proceed to second registration for randomization; arm A continues same systemic therapy alone, and arm B performs MDT followed by same systemic therapy. The MDT will involve either RT or surgery, and RT will involve mainly SBRT and partly conventional RT.