Actively Recruiting
Metastasis-directed Therapy for Oligometastases of Breast Cancer
Led by Tokyo Medical and Dental University · Updated on 2026-02-11
340
Participants Needed
1
Research Sites
468 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Metastasis-directed Therapy for Oligometastases of Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically diagnosed invasive breast cancer, with biopsy from oligometastases desirable but not required
- Classified as luminal, HER2-positive, or triple-negative breast cancer
- Diagnosed with advanced breast cancer with oligometastases via imaging (CT, PET, MRI)
- Oligometastases defined as maximum tumor diameter of 3 cm or less, total number of 3 or fewer, and brain metastases 2 cm or less and asymptomatic
- No distant metastases other than oligometastases
- Metastasis-directed therapy (radiation or surgery) must be feasible for all oligometastases
- No severe or uncontrolled bone metastasis conditions (e.g., spinal canal invasion, severe pain)
- Age between 18 and 80 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- No prior systemic, surgical, or radiotherapy treatment for distant metastases
- Disease-free interval of 12 months or more if recurrent breast cancer
- Adequate organ function and cardiac ejection fraction over 50%
- Written informed consent
You will not qualify if you...
- Active malignancies treated with no evidence of disease for 5 years or less prior to randomization
- Active infections or fever above 38°C
- Potential for pregnancy, recent delivery, or breastfeeding
- Mental disorders
- Continuous use of steroids or immunosuppressive drugs
- Recent unstable angina or heart attack
- Uncontrolled hypertension or diabetes
- Severe heart failure or cardiomyopathy
- Serious arrhythmia requiring treatment (except some specified types)
- Interstitial lung diseases or severe emphysema
- Positive for hepatitis B surface antigen
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tokyo Medical and Dental Univetsity
Tokyo, Tokyo, Japan, 1138510
Actively Recruiting
Research Team
T
Tohiyuki Ishiba, M.D.Ph.D.
CONTACT
I
Ikuno Nishibuchi, M.D.Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here