Metastasis-directed Therapy for Oligometastases of Breast Cancer
Status:
Recruiting
Trial end date:
2032-10-31
Target enrollment:
Participant gender:
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.