Stereotactic Body Radiotherapy for Breast Cancer with Bone Metastases
Stereotactic Body Radiotherapy for Bone Only Oligometastatic Breast Cancer: A Prospective Study
This study is testing if a special type of radiation therapy can help women with breast cancer that has spread to a few bones feel better and respond well to treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | King Hussein Cancer Center Academic / other |
| Locations | 1 site (Amman) |
| Trial ID | NCT04424732 on ClinicalTrials.gov |
What this trial studies
This study focuses on women over 18 years old who have been diagnosed with breast cancer that has spread to 1-3 bone metastases. Participants will receive stereotactic body radiotherapy (SBRT) along with standard systemic treatments as per clinical guidelines. The effectiveness of the treatment will be monitored through regular clinical and radiologic assessments, utilizing imaging methods that initially detected the metastases. The study aims to evaluate treatment outcomes and tumor response using established criteria.
Who should consider this trial
Good fit: Ideal candidates are women over 18 with pathologically confirmed breast cancer and 1-3 bone metastases.
Not a fit: Patients with non-bone metastatic breast cancer or those with contraindications to radiotherapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for women with oligometastatic breast cancer.
How similar studies have performed: Previous studies have shown promising results with stereotactic body radiotherapy in similar patient populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women \>18 years old with a pathologically proven breast cancer who present with 1-3 bone metastases will be included. * Metastases need to be confirmed pathologically if possible, otherwise two different imaging modalities (CTor MRI and bone scan or PET) are needed to confirm metastases. * Patients should be able to receive the recommended local and systemic treatment and the primary tumor must be controlled at time of SBRT. * Maximum diameter of individual metastasis metastasis in any dimension ≤ 5 cm; and must be \>5 cm away from each other (defined as Edge to Edge of tumor). Exclusion Criteria: * Non bone metastatic breast cancers * Prior history of radiotherapy to same sites of SBRT * Pathologic fractures of involved bones * Contraindications to radiotherapy including pregnancy and connective tissue disease. * Patients with impaired cognitive functions.
Where this trial is running
Amman
- King Hussein Cancer Center — Amman, Jordan (Recruiting)
Study contacts
- Principal investigator: Abdulmajeed Dayyat, MD — King Hussein Cancer Center
- Study coordinator: Abdulmajeed H Dayyat, MD
- Email: adayyat@khcc.jo
- Phone: 0096265300460
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.