Phase 3Recruiting
Metastasis-directed Therapy for Oligometastases of Breast Cancer (OLIGAMI)
a Randomized Trial for OLIGo Metastases Breast cAncer With or Without Metastasis-dIrected Therapy
- Sponsor
- Tokyo Medical and Dental University (Academic or other)
- Enrolment
- 146 planned
- Conditions
- Breast Cancer; Oligometastasis; Metastatic Breast Cancer
- Interventions
- Systemic therapy for 12 weeks after primary registration; Radiation therapy (SBRT/conventional RT); Surgery; Same systemic therapy after secondary registration
- Ages
- adults, older adults
- Registry
- NCT06135714
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Overall survival after second registration
History
Study completion expected
Primary completion expected
Last registry update
Registered
Started