Recruiting

SF PBI vs. MF PBI

Sponsor:

British Columbia Cancer Agency

Code:

NCT06885671

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Multiple Fraction PBI

Single Fraction PBI

Study Details

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 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.

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Study ID

NCT06885671

Start date

Jun 8, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Not accepted

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 radiotherapy (e.g., connective tissue disorders such as lupus or scleroderma)
  • Pregnant or breastfeeding

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Multiple Fraction PBI (Arm 1)

For participants randomized to Arm 1, PBI will be delivered with a dose of 26 Gy in 5 daily fractions.

experimental: Single Fraction PBI (Arm 2)

For participants randomized to Arm 2, PBI will be delivered in a single fraction with a dose of 13 Gy.

Interventions

Multiple Fraction PBI

Participants randomized to Arm 1 will receive PBI with a dose of 26 Gy in 5 daily fractions.

Single Fraction PBI

Participants randomized to Arm 2 will receive PBI in a single fraction with a dose of 13 Gy.

Primary outcome measure

  • Number of participants accrued [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Robert Olson, MD, MSC, FRCPC

250-645-7300rolson2@bccancer.bc.ca

Lindsay Mathews

250-645-7300lindsay.mathews@bccancer.bc.ca

Locations

BC Cancer - Prince George

Recruiting

Prince George, British Columbia, Canada, V2M 7E9

Contacts

Robert Olson A Radiation Oncologist, MD FRCPC MSc

250-645-7300rolson2@bccancer.bc.ca

Kaitlin Earl, BHSc

250-645-7300Kaitlin.Earl@bccancer.bc.ca

Principal Investigator:

Robert A Olson, MD FRCPC MSc

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Aug 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2026-08-26.