OncoMatch/Clinical Trials/NCT06135714
Metastasis-directed Therapy for Oligometastases of Breast Cancer
Is NCT06135714 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Systemic therapy for 12 weeks after primary registration and Same systemic therapy after secondary registration for breast cancer.
Treatment: Systemic therapy for 12 weeks after primary registration · Same systemic therapy after secondary registration — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (ER positive or negative)
Histologically proven positive/negative for ER
Required: PR (PGR) expression (PgR positive or negative)
Histologically proven positive/negative for PgR
Required: HER2 (ERBB2) expression (HER2 positive or negative)
Histologically proven positive/negative for HER2
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: surgery, drug therapy, or radiotherapy for distant metastasis
Exception: Bisphosphonate preparations and RANKL inhibitors before registration, and surgery for the purpose of diagnosing metastasis are permitted.
No history of surgery, drug therapy, or radiotherapy for distant metastasis. Bisphosphonate preparations and RANKL inhibitors before registration, and surgery for the purpose of diagnosing metastasis are permitted.
Cannot have received: radical surgery of the primary tumor or regional lymph nodes between diagnosis of oligometastasis to registration
No radical surgery of the primary tumor or regional lymph nodes between diagnosis of oligometastasis to registration.
Cannot have received: endocrine therapy, chemotherapy, molecular targeted therapy, and immunotherapy against any other malignancies within 5 years
No prior treatment of endocrine therapy, chemotherapy, molecular targeted therapy, and immunotherapy against any other malignancies within 5 years.
Lab requirements
Blood counts
ANC >= 1500 cells/mm3; Hemoglobin >= 9.0 g/dL; Platelet count >= 100,000/mm3
Kidney function
Creatinine <= 1.5 mg/dL (<= 2.3 mg/dL for luminal breast cancer)
Liver function
Serum bilirubin <= 1.5 mg/dL; AST <= 100 U/L; ALT <= 100 U/L
Cardiac function
Ejection fraction of cardiac function is defined over 50%
Adequate organ function within 14 days prior to the first registration. (i) ANC >= 1500 cells/mm3 (ii) Hemoglobin >= 9.0 g/dL (iii) Platelet count >= 100,000/ mm3 (iv) Serum bilirubin <= 1.5 mg/dL (v) AST <= 100 U/L (vi) ALT <= 100 U/L (vii) Creatinine <= 1.5 mg/dL (<= 2.3 mg/dL for luminal breast cancer). Ejection fraction of cardiac function is defined over 50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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