Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS) (NCT05217966) | Clinical Trial Compass
RecruitingNot Applicable
Single Pre-Operative Radiation Therapy - With Delayed or No Surgery (SPORT-DNS)
Canada80 participantsStarted 2021-10-08
Plain-language summary
Eligible women will receive neoadjuvant single fraction radiotherapy followed by surgery performed after one year
Who can participate
Age range
50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female aged 50 years or older.
. Postmenopausal status (Defined as: age 60 OR bilateral ovariectomy OR amenorrhea \> 12 months prior to breast cancer diagnosis without using oral contraceptives/hormone replacement therapy) (65).
. World Health Organization (WHO) performance status 0-2.
. Invasive ductal carcinoma proven by biopsy done ≤ 12 weeks from treatment start.
. Unifocal disease on preoperative staging ultrasound or MRI done ≤ 12 weeks from treatment start.
. Tumors less than or equal to 2cm clinically on physical exam, as well as on breast ultrasound.
. No clinical evidence of nodal disease (i.e. cN0), on physical examination done ≤ 12 weeks from treatment start, as well as on breast ultrasound.
. Estrogen receptor status (ER) positive on biopsy ≥ 80%.
Exclusion criteria
. Age less than 50 years.
. Premenopausal or uncertain menopausal status.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.