A Phase I-II Study of Stereotactic Body Radiation Therapy for Breast Cancer (SBRT Breast)

Toronto Sunnybrook Regional Cancer Centre1 site in 1 country24 target enrollmentJuly 17, 2018

ConditionsBreast Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Toronto Sunnybrook Regional Cancer Centre
Enrollment: 24
Locations: 1
Primary Endpoint: Acute toxicity
Status: Active, Not Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, single institution, phase I-II study of stereotactic body radiotherapy (SBRT) for unresected breast cancer. Twenty-four patients with advanced breast cancer who are not candidates for surgery (metastatic disease, unresectable, medically inoperable) or decline surgery will be enrolled in a prospective study using SBRT (4 fractions of radiation therapy over 12-15 days) as the primary treatment modality.

Registry

clinicaltrials.gov

Start Date

July 17, 2018

End Date

July 17, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Toronto Sunnybrook Regional Cancer Centre

Responsible Party

Principal Investigator

Danny Vesprini, MD, MSc, FRCPC

Deputy Chief, Department of Radiation Oncology - Clinical Care

Toronto Sunnybrook Regional Cancer Centre

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed diagnosis of invasive breast carcinoma of non-lobular histology.
•Unifocal tumour Previously assessed by a breast surgeon and medical oncologist, with no surgery being recommended at time of enrollment.
•Primary breast and axillary surgery not recommended/performed due to any of the following:
•distant metastatic disease
•unresectable T4 disease and/or
•medically inoperable and/or
•patient declined breast surgery Stages T1-T4, N1-N2, M0-M1 disease Ability to attend radiation planning and therapy, able to attend for follow-up care Able to provide written informed consent.

Exclusion Criteria

•Received chemotherapy within 3 weeks prior to breast SBRT. (Concurrent endocrine therapy is permitted) Multifocal or multicentric tumours. Ipsilateral supraclavicular or infraclavicular nodal disease \>= 1cm size that is at the level of or superior to the brachial plexus Unable to meet the brachial plexus dose constraints despite compromising coverage of target volumes - as per the discretion of the treating physician Treatment target volume estimated to occupy \> 50% of the ipsilateral whole breast volume.
•Locally recurrent breast cancer, with previous radiotherapy to the breast, or previous lumpectomy or mastectomy. Ipsilateral breast implant. Serious non-malignant disease that precludes definitive surgical or radiation treatment (e.g.
•scleroderma, systemic lupus erythematosus, cardiovascular/pulmonary/renal disease).
•Women who are pregnant or lactating. Psychiatric or addictive disorders that preclude obtaining informed consent or adherence to protocol