Role of Metastases Directed Radiotherapy in Addition to Standard of Care Systemic Treatment in the Management of Extracranial Oligometastatic Breast Cancer
Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other, Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Egypt
National Cancer Institute
RECRUITING
Cairo
Contact Information
Primary
Rimoun R Boutrus, M.D.
rimoun.boutrus@nci.cu.edu.eg
+201061056900
Backup
Joseph S Nayrouz, M.D.
j_nayrouz@yahoo.com
+201272148324
Time Frame
Start Date: 2023-09-20
Estimated Completion Date: 2028-09-20
Participants
Target number of participants: 150
Treatments
Active_comparator: Standard of Care
systemic and palliative treatment according to physician discretion
Experimental: Metastases Directed Therapy
SABR for all metastatic sites followed by systemic treatment for 6 months
Experimental: Locoregional Treatment of the Primary
patients who respond to MDT and ST will be randomized to undergo loco-regional treatment or not
Related Therapeutic Areas
Sponsors
Leads: National Cancer Institute, Egypt