Metastases Directed Therapy for Oligometastatic Breast Cancer
Recruiting · NCT06144346 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Locoregional treatmentStandard of CareStereotactic Ablative Radiation Therapy
What this trial is about
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
Who can take part
Age range
18 Years to 70 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
1 location listed.
- National Cancer Institute - Cairo, Egypt