COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01717261
Recruitment Status : Recruiting
First Posted : October 30, 2012
Last Update Posted : April 12, 2019
Information provided by (Responsible Party):
Michael Yassa, 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Single Pre-Operative Radiation Therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : August 2012
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Single Pre-Operative Radiation Therapy 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.

Primary Outcome Measures :
  1. Acute toxicity [ Time Frame: 6 months ]
    Assess acute toxicity and wound healing complications from the preoperative radiation treatment as per NCI CTCAE Common Toxicity Scale.

Secondary Outcome Measures :
  1. Chronic toxicity [ Time Frame: 2 years ]
    Assess late-onset toxicity associated with a single fraction radiation treatement as per RTOG/EORTC Late Radiation Toxicity Scale

  2. Cosmetic outcome [ Time Frame: 5 years ]
    Cosmesis will be evaluated as per the EORTC Breast Cancer Cosmetic Rating scale.

Other Outcome Measures:
  1. Ipsilateral breast cancer recurrence [ Time Frame: 5 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01717261

Layout table for location contacts
Contact: Michael Yassa, MD 15142523425

Layout table for location information
Canada, Quebec
Maisonneuve-Rosemont Hospital Recruiting
Montreal, Quebec, Canada, H1T 2M4
Contact: Linda Roy-Huneault    5142523425   
Principal Investigator: Michael Yassa, MD         
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Layout table for investigator information
Study Chair: Michael Yassa, MD Maisonneuve-Rosemon Hospital
Layout table for additonal information
Responsible Party: Michael Yassa, Radiation Oncologist, Maisonneuve-Rosemont Hospital Identifier: NCT01717261    
Other Study ID Numbers: 12030
First Posted: October 30, 2012    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Keywords provided by Michael Yassa, Maisonneuve-Rosemont Hospital:
breast cancer
early breast cancer
partial breast irradiation
preoperative radiation
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases