Actively Recruiting
Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS)
Led by Maisonneuve-Rosemont Hospital · Updated on 2024-11-19
80
Participants Needed
2
Research Sites
481 weeks
Total Duration
On this page
Sponsors
M
Maisonneuve-Rosemont Hospital
Lead Sponsor
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborating Sponsor
AI-Summary
What this Trial Is About
Eligible women will receive neoadjuvant single fraction radiotherapy followed by surgery performed after one year
CONDITIONS
Official Title
Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 50 years or older
- Postmenopausal status defined as age 60 or older, bilateral ovariectomy, or amenorrhea for more than 12 months before breast cancer diagnosis without hormone therapy
- WHO performance status 0 to 2
- Invasive ductal carcinoma confirmed by biopsy within 12 weeks before treatment
- Unifocal disease shown on ultrasound or MRI within 12 weeks before treatment
- Tumors 2 cm or smaller by physical exam and breast ultrasound
- No clinical signs of lymph node involvement (cN0) by exam and ultrasound within 12 weeks before treatment
- Estrogen receptor positive on biopsy (80% or higher)
- Progesterone receptor positive on biopsy (20% or higher)
- HER2 negative on biopsy
- No lymphovascular invasion on biopsy
- Low Oncotype DX recurrence score (18 or less) on biopsy
- Planned partial mastectomy with sentinel lymph node biopsy
You will not qualify if you...
- Age less than 50 years
- Premenopausal or uncertain menopausal status
- Known harmful mutation in BRCA 1 or BRCA 2 genes
- Tumor larger than 2.0 cm on ultrasound staging
- Tumor type limited to lobular carcinoma only
- Clinically positive axillary lymph nodes (cN+)
- Lymphovascular invasion present on biopsy
- Ductal or lobular carcinoma in situ only on biopsy
- Extensive intraductal component on biopsy
- Prior neoadjuvant hormonal therapy or chemotherapy
- Non basal or squamous cell skin cancer in last 5 years
- More than one primary tumor in different breast quadrants
- Diffuse microcalcifications on mammogram
- Paget's disease of the nipple
- Previous radiation to the same breast
- Ipsilateral breast implant or pacemaker present
- Serious non-cancer diseases preventing radiation treatment
- Unknown estrogen receptor status
- Currently pregnant or breastfeeding
- Psychiatric or addiction disorders affecting consent or adherence
- Unable to access follow-up locations
- No preoperative breast and axillary ultrasound staging
- Unable to plan for experimental radiation technique
- Prior breast cancer history
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Actively Recruiting
2
McGill University Health Center
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
Research Team
M
Michael Yassa
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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