Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer

Maisonneuve-Rosemont Hospital

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Radiation: Single Pre-Operative Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01717261

12030

Details and patient eligibility

About

The purpose of this study is to determine if partial breast irradiation administered in a single preoperative fraction is tolerable.

Enrollment: 10 estimated patients

Sex: Female

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Single Pre-Operative Radiation Therapy

Experimental group

Treatment:

Radiation: Single Pre-Operative Radiation Therapy