Trial Information
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Acute toxicity
Outcome Description:
Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.
Outcome Time Frame:
6 months
Safety Issue:
Yes
Principal Investigator
Michael Yassa, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Maisonneuve-Rosemon Hospital
Authority:
Canada: Institutional Review Board
Study ID:
12030
NCT ID:
NCT01717261
Start Date:
August 2012
Completion Date:
May 2019
Related Keywords:
- Breast Cancer
- breast cancer
- early breast cancer
- partial breast irradiation
- preoperative radiation
- Breast Neoplasms