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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT to the Primary Breast Tumour | Experimental | SBRT to the breast using 4 sequentially escalating dose levels from 9Gy to 12 Gy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT | Radiation | Each radiation treatment plan will be customized to the patient and tumour in order to deliver highly conformal, conebeam CT guided SBRT radiotherapy in 4 fractions delivered over 2-4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | Incidence of side effects /toxicity associated with SBRT to the breast, during and in the three months following treatment using CTCAE v4.0 | 12 weeks post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Breast Symptom Scores | Patient reported breast symptom scores for bleeding, discharge and odour measured on a scale from 1 (no symptoms) to 10 (worst possible/continuous symptoms) using the Visual Analogue Scale tool | 2 years post treatment |
| Patient Reported Quality of Life |
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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:
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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| Name | Affiliation | Role |
|---|---|---|
| Danny Vesprini, MD, FRCPC | Sunnybrook Health Sciences Centre, University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Odette Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Sequential dose escalation design
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|
Patient reported quality of life measured using the combined EORTC QLQ-C30 and QLQ-BR23 questionnaires |
| 2 years post treatment |
| Patient Reported Quality of Life | Patient reported quality of life measured using the VES13 questionnaire. | 2 years post treatment |
| Patient Reported Pain Level | Patient reported pain levels measured on a scale from 1 (no pain) to 10 (maximum pain tolerable) using the Visual Analogue Scale for Pain | 2 years post treatment |
| Tumour Response Rate | Measured on follow-up MRI or CT imaging using RECIST criteria | 2 years post treatment |
| D017437 |
| Skin and Connective Tissue Diseases |