Treatment 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
This study is testing whether adding a special type of radiation therapy to standard treatment can help women with a few metastatic breast cancer spots live longer and feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | National Cancer Institute, Egypt Academic / other |
| Drugs / interventions | Radiation |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06144346 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of adding metastases directed therapy, specifically Stereotactic Ablative Radiation Therapy (SABR), to standard systemic treatment in women with oligometastatic breast cancer. Participants will be randomly assigned to receive either standard care alone or standard care plus SABR, with the aim of assessing progression-free survival and quality of life. The study also investigates the safety profile of the combined treatment approach. The trial is conducted at the National Cancer Institute in Cairo, Egypt, focusing on adult female patients with a limited number of metastatic lesions.
Who should consider this trial
Good fit: Ideal candidates are adult female patients aged 18 to 70 with oligometastatic breast cancer and a maximum of 5 extracranial metastatic lesions.
Not a fit: Patients with widespread metastatic disease or those with brain metastases will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve progression-free survival and quality of life for patients with oligometastatic breast cancer.
How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cairo
- National Cancer Institute — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Rimoun R Boutrus, M.D.
- Email: rimoun.boutrus@nci.cu.edu.eg
- Phone: +201061056900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.