Breast Cancer
Conditions
Keywords
breast cancer, early breast cancer, partial breast irradiation, preoperative radiation
Brief summary
The purpose of this study is to determine if partial breast irradiation administered in a single preoperative fraction is tolerable.
Interventions
RADIATIONSingle Pre-Operative Radiation Therapy
Dose escalation: 3 patients will receive 15 Gy in a single fraction. The following 3 patients will receive 18 Gy. The final 4 patients will receive 20 Gy.
Sponsors
Maisonneuve-Rosemont Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female aged 60 years or older. * Invasive ductal carcinoma. * Unifocal disease. * Tumors less than 2cm. * No clinical evidence of nodal disease. * Estrogen receptor status (ER) positive. * Her2 negative.
Exclusion criteria
* Age less than 60 years. * BRCA 1 and/or BRCA 2 mutation. * Tumour histology limited to lobular carcinoma only. * Neoadjuvant hormonal manipulation or chemotherapy. * More than one primary tumour in different quadrants of the same breast. * Inability to view tumor on imaging.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicity | 6 months | Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic toxicity | 2 years | Assess late-onset toxicity associated with a single fraction radiation treatement as per RTOG/EORTC Late Radiation Toxicity Scale |
| Cosmetic outcome | 5 years | Cosmesis will be evaluated as per the EORTC Breast Cancer Cosmetic Rating scale. |
Other
| Measure | Time frame |
|---|---|
| Ipsilateral breast cancer recurrence | 5 years |
Countries
Canada
Outcome results
None listed