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

Breast Cancer Clinical Trial

— SPORT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01717261
• Other study ID #: 12030
• Status: Completed
• Phase: Phase 1
• Start date: August 2012
• Est. completion date: October 2023

Study information

• Verified date: October 2023
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2023
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Single Pre-Operative Radiation Therapy
Dose escalation: 3 patients will receive 15 Gy in a single fraction. The following 3 patients will receive 18 Gy. The final 4 patients will receive 20 Gy.

Locations

Country	Name	City	State
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ipsilateral breast cancer recurrence		5 years
Primary	Acute toxicity	Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.	6 months
Secondary	Chronic toxicity	Assess late-onset toxicity associated with a single fraction radiation treatement as per RTOG/EORTC Late Radiation Toxicity Scale	2 years
Secondary	Cosmetic outcome	Cosmesis will be evaluated as per the EORTC Breast Cancer Cosmetic Rating scale.	5 years