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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.
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. Both techniques have evidence for use in clinical care. Multiple fraction is offered to reduce the amount of radiation given at a single time that could reduce late toxicities. However, single fraction radiotherapy is more cost-effective and saves patient time. With this trial, we will compare single fraction vs. multiple fraction PBI in regards to their impact on quality of life, rates of provider and participant reported toxicities, and local control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multiple Fraction PBI (Arm 1) | Active Comparator | For participants randomized to Arm 1, PBI will be delivered with a dose of 26 Gy in 5 daily fractions. |
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| Single Fraction PBI (Arm 2) | Experimental | For participants randomized to Arm 2, PBI will be delivered in a single fraction with a dose of 13 Gy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple Fraction PBI | Radiation | Participants randomized to Arm 1 will receive PBI with a dose of 26 Gy in 5 daily fractions. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants accrued | Number of participants who sign consent to be randomized to 1 vs 5 fractions of radiotherapy for PBI over a 2 year period | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time from CT simulation to plan approval | Measured as the time from the day of CT simulation to the date of plan approval. | Baseline |
| 2-Year Local Control Rates | Absence of ipsilateral in-breast recurrence, defined as histologic evidence of invasive or in situ breast cancer in the ipsilateral breast 2 years post-treatment |
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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:
Negative pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of RT start date
Exclusion Criteria:
Eligible participants must be biologically female.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert Olson, MD, MSC, FRCPC | Contact | 250-645-7300 | rolson2@bccancer.bc.ca | |
| Lindsay Mathews | Contact | 250-645-7300 | lindsay.mathews@bccancer.bc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Robert Olson, MD, MSc, FRCPC | BC Cancer - Prince George | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Cancer - Prince George | Recruiting | Prince George | British Columbia | V2M 7E9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40781619 | Derived | Olson R, Cua M, Matthews Q, Laing J, Narinesingh D, Nichol A, Berrang T, Koulis T, Karan T, Chng N. Phase II single vs hypofractionated irradiation for timely access to partial breast radiotherapy (SHIFT-PB). BMC Cancer. 2025 Aug 8;25(1):1285. doi: 10.1186/s12885-025-14720-w. |
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This is a phase II randomized controlled trial, with the primary objective of testing feasibility of accruing 60 participants with early stage, node negative, breast cancer at 4 of the 6 BC Cancer centres and randomizing them to single vs. multiple fraction partial breast irradiation (PBI). Participants will be randomized 1:1 to 13Gy in 1 fraction vs 26 Gy in 5 fractions.
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This will is an open-label randomized controlled study design, however, outcome assessors and data analysts will be blinded to the identity of each treatment arm.
| Single Fraction PBI | Radiation | Participants randomized to Arm 2 will receive PBI in a single fraction with a dose of 13 Gy. |
|
| 6 weeks, 6 months, 12, months, 18 months, and 24 months post-treatment |
| Quality of life assessed using the POSI-Breast questionnaire | Prospective Outcomes and Support Initiative (POSI) for Breast Data will be used to measure and compare the quality of life of participants in both arms. | Baseline, 6 weeks, 6 months, 12 months, 18 months, and 24 months post treatment |
| Rates of provider-rated toxicities: Occurrences of adverse events as measured by CTCAE | Participant-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Data will be used to measure and compare participant-reported toxicities in both arms. | Baseline, 6 weeks, 6 months, 12 months, 18 months, and 24 months post treatment |
| Participant-reported toxicities | Occurrences of adverse events as measured by PRO-CTCAE | Baseline, 6 weeks, 6 months, 12, months, 18 months, and 24 months post-treatment |
| Overall Survival (OS) | Time from randomization to death from any cause, or last follow-up, whichever occurs first. | Approximately at the end of year 2 (study completion) |
| Progression-Free Survival (PFS) | Time from randomization to disease progression at any site, death, or last follow-up, whichever occurs first. | 6 weeks, 6 months, 12 months, 18 months, and approximately at the end of 24 months |