Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy (NCT06885671) | Clinical Trial Compass
RecruitingNot Applicable
Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy
Canada60 participantsStarted 2026-06-08
Plain-language summary
Partial Breast Irradiation (PBI) is a targeted radiation approach commonly administered post-lumpectomy, specifically targeting the tumour bed. This targeted therapy reduces the exposure to other nearby tissues such as lungs, heart, and chest wall. However, traditional PBI treatment involves lengthy multiple fraction courses which presents a burden to patients from rural and remote communities, who must travel long distances to receive high quality cancer care. The purpose of this study is to compare single fraction (SF) PBI vs. multiple fraction (MF) PBI.
Who can participate
Age range
40 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 participants age 40 or older
* Able to provide informed consent
* pTis-2 pN0 cM0 breast cancer, with tumor size \<3 cm as per provincial guidelines
* Able to complete electronic or paper entry of participant reported outcomes independently or with assistance from caregiver/family/friend/research staff
* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
* A history and physical (clinical breast) examination, including ECOG performance status, performed within 8 weeks prior to enrollment.
* Participant is judged able to:
* Maintain a stable position during therapy
* Tolerate immobilization device(s) that may be required to deliver PBI safely
* Negative pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of RT start date
Exclusion Criteria:
* History of non-breast malignancies except adequately treated non-melanoma skin cancers, in situ cancers treated by local excision or other cancers curatively treated with no evidence of disease for ≥ 5 years.
* Uncontrolled concurrent malignant cancer
* Seroma not visible
* Ipsilateral implanted cardiac device
* Prior radiotherapy requiring summation for planning.
* Requirement for a radiation boost (as determined by the treating investigator)
* Positive surgical margins
* Surgical cavities lacking clear delineation (surgical clips are not required but may assist in target delineation)
* Known germline BRCA1/2 mutation.
* Serious medical comorbidities precluding r…
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.