Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy
Phase II Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy: SHIFT-PB
British Columbia Cancer Agency
60 participants
Jun 8, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria10
- 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 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 Criteria12
- 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.
- Inability to meet mandatory planning constraints.
- 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 radiotherapy (e.g., connective tissue disorders such as lupus or scleroderma)
- Pregnant or breastfeeding
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Participants randomized to Arm 1 will receive PBI with a dose of 26 Gy in 5 daily fractions.
Participants randomized to Arm 2 will receive PBI in a single fraction with a dose of 13 Gy.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06885671