SBRT for Breast Cancer Oligometastases

Not Applicable

Recruiting

• Conditions: Breast Neoplasm Malignant Female
• Interventions: Radiation: Stereotactic Body Radiotherapy

• Registration Number: NCT04424732
• Lead Sponsor: King Hussein Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-06
• Study Start: 2020-06-01
• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-05
• Last Update Submitted: 2020-06-05
• Study First Posted: 2020-06-11
• Last Update Posted: 2020-06-11
• Primary Completion: 2023-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stereotactic Body Radiotherapy for Breast Bony oligometastases	Stereotactic Body Radiotherapy	Newly diagnosed bone only oligometastatic breast cancers with 1-3 bone metastases will be enrolled in this protocol. Patients will receive SBRT to all metastatic sites.

Primary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	5 years	the interval from diagnosis until disease progression
Overall survival (OS)	5 years	time from diagnosis to death from any cause or last follow-up

Secondary Outcome Measures

Name	Time	Method
Existing metastasis control	3 years	the interval from diagnosis until local progression of the treated metastases
Appearance of new metastases	3 years	the interval from diagnosis until appearance of new metastases
Adverse Events	3 years	CTCAE v5. for acute and chronic toxicity reporting and scoring

Trial Locations

Locations (1)

King Hussein Cancer Center; 🇯🇴 Amman, Jordan