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

Phase 1

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01717261
• Lead Sponsor: Maisonneuve-Rosemont Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-10-22
• Study First Submitted QC: 2012-10-26
• Study First Posted: 2012-10-30
• Primary Completion: 2018-12
• Status Verified: 2023-10
• Study Completion: 2023-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Acute toxicity	6 months	Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Maisonneuve-Rosemont Hospital; 🇨🇦 Montreal, Quebec, Canada