Metastasis-directed Therapy for Oligometastases of Breast Cancer

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-negat

Trial Details

NCT ID
NCT06135714
Phase
PHASE3
Sponsor
Tokyo Medical and Dental University
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Systemic therapy for 12 weeks after primary registration
  • Radiation therapy (SBRT/conventional RT)
  • Surgery
  • Same systemic therapy after secondary registration
Locations (sample)
  • Tokyo, Tokyo, Japan|35.6895,139.69171

Key Eligibility Criteria

  • Primary Registration Eligibility Criteria:
  • Histologically diagnosed as invasive breast cancer. Biopsy from oligometastasis is desirable but not required.
  • Histologically proven positive/negative for ER, PgR, and HER2, and classified as luminal, HER2-positive, or TN breast cancer.
  • One of the following \<1\> to \<4\>; \<1\>In case of no history of breast cancer in the past, either (i) or (ii) below.

For full eligibility, visit ClinicalTrials.gov.

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