Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
breast cancer, early breast cancer, partial breast irradiation, preoperative radiation
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Single Pre-Operative Radiation Therapy
Type: Radiation
Overall Status
Recruiting
Summary
The purpose of this study is to determine if partial breast irradiation administered in a single preoperative fraction is tolerable.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 60 Years
Gender: Female
Criteria: 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.
Location
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Status: Recruiting
Contact: Linda Roy-Huneault - 5142523425 - lroyhuneault.hmr@ssss.gouv.qc.ca
Start Date
August 2012
Completion Date
May 2019
Sponsors
Maisonneuve-Rosemont Hospital
Source
Maisonneuve-Rosemont Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page