Breast Cancer Early Stage Breast Cancer (Stage 1-3)NCT06885671
Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy
A study testing Multiple Fraction PBI and Single Fraction PBI in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by British Columbia Cancer Agency at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- What is being tested?
- Multiple Fraction PBI and Single Fraction PBI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 8 Jun 2026to 31 Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
BC Cancer - Prince George
Prince George, British Columbia, V2M 7E9
Robert Olson A Radiation Oncologist, MD FRCPC MSc, 250-645-7300, rolson2@bccancer.bc.ca
Kaitlin Earl, BHSc, 250-645-7300 ext. 687427, Kaitlin.Earl@bccancer.bc.ca
About this study
Official title: Phase II Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy: SHIFT-PB
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.
Read the 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. 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.
- Being tested
- Multiple Fraction PBI, Single Fraction PBI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple Fraction PBIRadiation
Participants randomized to Arm 1 will receive PBI with a dose of 26 Gy in 5 daily fractions.
Single Fraction PBIRadiation
Participants randomized to Arm 2 will receive PBI in a single fraction with a dose of 13 Gy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Multiple Fraction PBI |
| 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. Receives: Radiation: Single Fraction PBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (7)
Time from CT simulation to plan approval
Measured as the time from the day of CT simulation to the date of plan approval.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 weeks, 6 months, 12 months, 18 months, and approximately at the end of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start8 Jun 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Olson, MD, MSc, FRCPC, Principal investigator, BC Cancer - Prince George
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885671
- Sponsor's protocol ID
- SHIFT-PB
- Status last verified
- Jun 2026
- First submitted
- 14 Mar 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40781619