Status:
NOT_YET_RECRUITING
Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy
Lead Sponsor:
British Columbia Cancer Agency
Conditions:
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Eligibility:
FEMALE
40+ years
Phase:
NA
Brief 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 near...
Detailed Description
Radiation can be delivered in multiple fractions, or doses, and can take up to several weeks or months of treatment depending on the type of cancer. Radiation can also be offered in a single fraction....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06885671
Start Date
January 1 2026
End Date
December 31 2029
Last Update
November 17 2025
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