Breast Cancer
Conditions
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.
Interventions
RADIATIONSBRT
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.
Sponsors
Toronto Sunnybrook Regional Cancer Centre
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Sequential dose escalation design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicity | 12 weeks post treatment | Incidence of side effects /toxicity associated with SBRT to the breast, during and in the three months following treatment using CTCAE v4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Breast Symptom Scores | 2 years post treatment | 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 |
| Patient Reported Quality of Life | 2 years post treatment | Patient reported quality of life measured using the combined EORTC QLQ-C30 and QLQ-BR23 questionnaires |
| Patient Reported Pain Level | 2 years post treatment | Patient reported pain levels measured on a scale from 1 (no pain) to 10 (maximum pain tolerable) using the Visual Analogue Scale for Pain |
| Tumour Response Rate | 2 years post treatment | Measured on follow-up MRI or CT imaging using RECIST criteria |
Countries
Canada
Outcome results
None listed