NCT01717261CompletedPhase 1
Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer
Maisonneuve-Rosemont Hospital1 site in 1 country10 target enrollmentStarted: August 1, 2012Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Acute toxicity
Study Overview
Brief Summary
The purpose of this study is to determine if partial breast irradiation administered in a single preoperative fraction is tolerable.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
Single Pre-Operative Radiation Therapy
Experimental
Intervention: Single Pre-Operative Radiation Therapy (Radiation)
Outcomes
Primary Outcomes
Acute toxicity
Time Frame: 6 months
Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.
Secondary Outcomes
- Cosmetic outcome(5 years)
- Chronic toxicity(2 years)
Investigators
Michael Yassa
Radiation Oncologist
Maisonneuve-Rosemont Hospital
Study Sites (1)
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