Trial details
A Phase I-II Study of Stereotactic Body Radiation Therapy for Breast Cancer
To find out more about this trial and your cancer treatment options, please speak with your doctor.
Trial short name: SBRT BREAST
Official title: A Phase I-II Study of Stereotactic Body Radiation Therapy for Breast Cancer
Principal Investigator: Dr. Danny Vesprini
Cancer type: Breast
Cancer location: Breast
Disease stage: Advanced Cancer
Trial phase: Phase 1
Intervention: Radiation: SBRT
Registration #:
NCT03585621 
Contact name: Tammy Taite
Contact phone: (416) 480-5000 x7934
Trial description:
This is a study of stereotactic body radiotherapy (SBRT) for unresected breast cancer. Twenty-four patients with advanced breast cancer who are not candidates for surgery or who 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.
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: o distant metastatic disease o unresectable T4 disease and/or o medically inoperable and/or o 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
