Metastases Directed Therapy for Oligometastatic Breast Cancer

Recruiting now · Not applicable

Conditions studied: Breast Cancer, Metastatic Cancer, Metastatic Breast Cancer

In brief

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

Key facts

Study ID

NCT06144346

Run by

National Cancer Institute, Egypt

People needed

150

Starts

2023-09-20

Expected to finish

2028-09-20

Last updated by the study team

2023-11-22

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• .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

Where it is running

• National Cancer Institute — Cairo, Egypt (enrolling)

Full record on ClinicalTrials.gov

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