Metastases Directed Therapy for Oligometastatic Breast Cancer
NCT06144346 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2023-11-22
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
Conditions
Interventions
- RADIATION
-
Stereotactic Ablative Radiation Therapy
SABR to all metastatic lesions
- PROCEDURE
-
Locoregional treatment
mastectomy or BCS for the primary tumor
- OTHER
-
Standard of Care
Systemic treatment and palliative treatment
Sponsors & Collaborators
-
National Cancer Institute, Egypt
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-20
- Primary Completion
- 2025-08-19
- Completion
- 2028-09-20
Countries
- Egypt
Study Locations
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