Single Pre-Operative Radiation Therapy (SPORT) for Low Risk Breast Cancer
NCT ID: NCT01717261
Last Updated: 2023-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2012-08-31
2023-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Pre-Operative Radiation Therapy
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Invasive ductal carcinoma.
* Unifocal disease.
* Tumors less than 2cm.
* No clinical evidence of nodal disease.
* Estrogen receptor status (ER) positive.
* Her2 negative.
Exclusion Criteria
* 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.
60 Years
FEMALE
No
Sponsors
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Maisonneuve-Rosemont Hospital
OTHER
Responsible Party
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Michael Yassa
Radiation Oncologist
Principal Investigators
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Michael Yassa, MD
Role: STUDY_CHAIR
Maisonneuve-Rosemon Hospital
Locations
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Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada
Countries
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Other Identifiers
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12030
Identifier Type: -
Identifier Source: org_study_id
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