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Radiation Therapy
Pre-Operative Radiotherapy for Breast Cancer (SPORT-DNS Trial)
N/A
Recruiting
Research Sponsored by Maisonneuve-Rosemont Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Planned surgery is a partial mastectomy with sentinel lymph node biopsy
Female aged 50 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-5 years
Awards & highlights
SPORT-DNS Trial Summary
This trial is testing whether giving radiotherapy before surgery to women with early stage breast cancer will improve outcomes.
Who is the study for?
This trial is for women aged 50 or older with early-stage breast cancer (tumors ≤2cm, ER positive ≥80%, PR positive ≥20%, Her2 negative) who are postmenopausal and have no nodal disease. It's not for those with BRCA mutations, premenopausal women, multiple tumors in one breast, prior cancers within 5 years (except certain skin cancers), or serious non-malignant diseases.Check my eligibility
What is being tested?
The SPORT-DNS trial tests a single pre-operative radiation therapy followed by surgery after one year in eligible women. The aim is to see how effective this approach is compared to traditional methods where surgery occurs sooner after radiation.See study design
What are the potential side effects?
Potential side effects of the radiation may include skin changes like redness and irritation at the treatment site, fatigue, swelling in the treated area (lymphedema), and rarely more serious complications such as heart or lung issues.
SPORT-DNS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a partial breast removal and sentinel lymph node biopsy.
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I am a woman aged 50 or older.
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My tumor is 2cm or smaller, confirmed by physical exam and ultrasound.
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My cancer has a low risk of coming back according to the Oncotype DX test.
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I am postmenopausal based on age, surgery, or not having periods for over a year.
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My biopsy shows I am progesterone receptor positive.
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My biopsy shows I am HER2 negative.
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My biopsy shows my cancer is mostly estrogen receptor positive.
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I can perform daily activities with little to no assistance.
SPORT-DNS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of pathological complete response
Secondary outcome measures
Incidence of grade 3 or greater radiation toxicity
SPORT-DNS Trial Design
1Treatment groups
Experimental Treatment
Group I: Preoperative radiotherapy for early breast cancerExperimental Treatment1 Intervention
Radiation: Single Pre-Operative Radiation Therapy
Find a Location
Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreOTHER
446 Previous Clinical Trials
159,646 Total Patients Enrolled
3 Trials studying Breast Cancer
550 Patients Enrolled for Breast Cancer
Maisonneuve-Rosemont HospitalLead Sponsor
99 Previous Clinical Trials
36,243 Total Patients Enrolled
1 Trials studying Breast Cancer
10 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Paget's disease of the nipple.You live too far away to come for check-ups and follow-up visits.You have a breast implant or a pacemaker on the same side as the affected breast.My scans show a single area of cancer, and these were done within the last 12 weeks.I am a woman aged 50 or older.You haven't had a breast and armpit ultrasound before surgery.My tumor is 2cm or smaller, confirmed by physical exam and ultrasound.I have had breast cancer before.My cancer is specifically lobular carcinoma.My cancer has a low risk of coming back according to the Oncotype DX test.Small calcium deposits are seen throughout the breast on a mammogram.My tumor is larger than 2 cm according to an ultrasound.I have had radiation therapy on the same side breast before.I am scheduled for a partial breast removal and sentinel lymph node biopsy.I do not have a serious illness like heart or lung disease that would prevent me from receiving radiation therapy.I am postmenopausal based on age, surgery, or not having periods for over a year.I cannot be properly planned for the experimental treatment.Your biopsy results show no signs of cancer spreading through the lymph or blood vessels.My biopsy shows I am progesterone receptor positive.My biopsy shows I am HER2 negative.I have a harmful BRCA1 or BRCA2 gene mutation.The biopsy shows a large amount of abnormal tissue inside the ducts.I am under 50 years old.I have received hormone therapy or chemotherapy before surgery.My exams show no signs of cancer in my lymph nodes.I am premenopausal or unsure about my menopausal status.There are signs that the cancer has spread into the blood or lymph vessels in the biopsy.My biopsy shows I have a non-invasive type of breast cancer.I have multiple tumors in different areas of the same breast.I have had skin cancer other than basal or squamous cell in the last 5 years.My underarm lymph nodes are affected by cancer.My estrogen receptor status is unknown.My biopsy shows my cancer is mostly estrogen receptor positive.I can perform daily activities with little to no assistance.My breast cancer was confirmed by a biopsy within the last 12 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Preoperative radiotherapy for early breast cancer
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it reasonable to assume that Radiation: Single Pre-Operative Radiation Therapy has no long-term consequences for those who undergo the treatment?
"Radiation: Single Pre-Operative Radiation Therapy has been assigned a safety rating of 2, since there is evidence to support its efficacy but not its effectiveness."
Answered by AI
What is the current enrollment count for this clinical investigation?
"Affirmative. The clinicaltrials.gov database affirms that this investigation is actively seeking participants, with the trial originally posted on October 8th 2021 and most recently updated on January 31st 2022. 80 people are being recruited from a single site for enrolment in this study."
Answered by AI
Are there any opportunities for people to participate in this trial currently?
"Clinicaltrials.gov confirms that this medical trial, which was initially launched on October 8th 2021, is actively recruiting participants. The information has been recently updated as of January 31st 2022."
Answered by AI
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