SBRT for Breast Cancer Oligometastases

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasm Malignant Female
• Intervention / Treatment: Radiation: Stereotactic Body Radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abdulmajeed H Dayyat, MD; Phone Number: 1860 0096265300460; Email: adayyat@khcc.jo

Study Locations

• Jordan
  • Amman, Jordan, 11941
    • Recruiting
    • King Hussein Cancer Center
    • Contact: Farah Zahran; Phone Number: 1346 0096265300460; Email: FZahran@KHCC.JO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

OTHER: Stereotactic Body Radiotherapy for Breast Bony oligometastases; 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.

Radiation: Stereotactic 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: King Hussein Cancer Center
• Investigators: Principal Investigator: Abdulmajeed Dayyat, MD, King Hussein Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): June 1, 2026

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (ACTUAL): June 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Stereotactic Body Radiotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Site; Breast Diseases; Neoplasms; Breast Neoplasms
• Other Study ID Numbers: 20 KHCC 91

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No