Clinical trial NCT04424732: SBRT for Breast Cancer Oligometastases
Official title: Stereotactic Body Radiotherapy for Bone Only Oligometastatic Breast Cancer: A Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Neoplasm Malignant Female
Keywords: Stereotactic Body Radiotherapy
Lead sponsor: King Hussein Cancer Center
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: 5 years
measure: Overall survival (OS)
timeFrame: 5 years
Secondary outcomes:
measure: Existing metastasis control
timeFrame: 3 years
measure: Appearance of new metastases
timeFrame: 3 years
measure: Adverse Events
timeFrame: 3 years
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: King Hussein Cancer Center
Study officials:
affiliation: King Hussein Cancer Center
name: Abdulmajeed Dayyat, MD
role: PRINCIPAL_INVESTIGATOR
References: