Metastasis-directed Therapy for Oligometastases of Breast Cancer

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.

Timeline

Start

2023-11-08

Primary completion

2029-11-08

Completion

2035-10-31

Publications

• Results Sasaki K, Ishiba T, Nishibuchi I, Hara F, Sekino Y, Machida R, Shibata T, Kawahara D, Sagara Y, Naito Y, Terata K, Ozaki Y, Shimomura A, Sakai T, Shigematsu H, Sudo K, Nozawa K, Yoshimura M, Shikama N, Mizowaki T, Shien T. A randomized controlled trial of metastasis-directed therapy for oligometastases in breast cancer: OLIGAMI trial (JCOG2110). Jpn J Clin Oncol. 2026 May 7;56(5):659-665. doi: 10.1093/jjco/hyag019.

Drugs

Indications