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NotablePrimary completion pushed from Nov 8, 2026 to Nov 8, 2029Enrollment reduced: 340 → 146 participants · Completion pushed from Oct 31, 2032 to Oct 31, 2035 · Interventions: Radiation therapy (SBRT/conventional RT) (Procedure), Same systemic therapy after secondary registration (Drug), Surgery (Procedure)… to Radiation therapy (SBRT/conventional RT) (Procedure), Same systemic therapy after secondary registration (Drug), Surgery (Procedure)… · 3 moreShow 6 more changesShow less
Enrollment reduced: 340 → 146 participants
Completion pushed from Oct 31, 2032 to Oct 31, 2035
Interventions: Radiation therapy (SBRT/conventional RT) (Procedure), Same systemic therapy after secondary registration (Drug), Surgery (Procedure)… to Radiation therapy (SBRT/conventional RT) (Procedure), Same systemic therapy after secondary registration (Drug), Surgery (Procedure)…
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.