Trial details
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A Phase I-II Study of Stereotactic Body Radiation Therapy for Breast Cancer
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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
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