Metastases Directed Therapy for Oligometastatic Breast Cancer
Role of Metastases Directed Radiotherapy in Addition to Standard of Care Systemic Treatment in the Management of Extracranial Oligometastatic Breast Cancer
National Cancer Institute, Egypt
150 participants
Sep 20, 2023
INTERVENTIONAL
Conditions
Summary
This is a phase III randomized study evaluating the benefit from adding metastases directed therapy and locoregional treatment of the primary in breast cancer patients diagnosed with de novo oligometastatic disease patients will be randomized to receive the standard of care (SOC) treatment vs. systemic treatment + Stereotactic Ablative Radiation Therapy. Responders will be randomized to either undergo loco-regional management of the primary tumor or not
Eligibility
Inclusion Criteria5
- Female patients aged 18 to 70 years.
- Pathological evidence of breast cancer, any grade, any T stage.
- Radiological (at least) evidence of metastatic activity with maximum number of 5 extracranial lesions.
- Performance status ≤ 2
- No pre-existing conditions that may prohibit radiotherapy.
Exclusion Criteria5
- •.Pregnant and lactating women.
- Prior radiotherapy to affected site(s) in less than a year.
- Active Connective tissue diseases (e.g Rheumatoid Arthritis).
- Progression to widespread metastatic disease
- Cases with brain metastasis
Interventions
SABR to all metastatic lesions
mastectomy or BCS for the primary tumor
Systemic treatment and palliative treatment
Locations(1)
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NCT06144346