RecruitingNot ApplicableNCT04424732

SBRT for Breast Cancer Oligometastases

Stereotactic Body Radiotherapy for Bone Only Oligometastatic Breast Cancer: A Prospective Study


Sponsor

King Hussein Cancer Center

Enrollment

50 participants

Start Date

Jun 1, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective data collection of treatment outcome for newly diagnosed oligometastatic breast cancers with 1-3 bone metastases. Eligible patients will be identified from the weekly Breast MDC. Patients will receive the recommended systemic and local treatment (including metastases directed SBRT) according to our clinical practice guidelines.Patients will be followed according to our routine with clinical and radiologic assessment. It is preferred that the same imaging method that was used to originally detect the metastases be used in follow-up assessments. The first imaging for SBRT sites will be three months post SBRT and every three months for the first year, every 6 months for the second year, then annually. Response and progression for these metastases will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions is used in the RECIST criteria. If functional imaging (bone scan, PET) were used at staging, changes in the uptake will be used in follow up scans to determine response to treatment and progression. As for SBRT related morbidities, we will use the Common Terminology Criteria for Adverse Events (CTCAE v5) for toxicity reporting and scoring.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a precise form of radiation called stereotactic body radiotherapy (SBRT) — which delivers high-dose, focused radiation in just a few sessions — for women with breast cancer that has spread to 1–3 bones (bone-only oligometastases), to see if it can control the cancer longer and reduce pain. **You may be eligible if...** - You are a woman over 18 with confirmed breast cancer - Your cancer has spread to 1 to 3 bones only - Each metastasis is 5cm or smaller and the spots are at least 5cm apart - Your primary breast tumor is under control - You are able to receive the recommended treatments **You may NOT be eligible if...** - Your cancer has spread to organs other than bone - You have already received radiation to the same bone sites - You have a broken or fractured bone at a metastatic site - You are pregnant or have a connective tissue disease that contraindicates radiation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONStereotactic Body Radiotherapy

This is a prospective study of breast bone only oligometastases (up to three sites). Following systemic treatment and primary tumor control, patients will receive SBRT to all metastatic sites. Data on toxicities and oncological outcomes will be collected for future analysis. There will be no change in the standard systemic therapy nor the local therapy of the primary tumor.


Locations(1)

King Hussein Cancer Center

Amman, Jordan

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NCT04424732


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