ClinicalTrials.gg
RecruitingNCT06885671Updated Aug 26, 2026

Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy

An interventional study of Multiple Fraction PBI and Single Fraction PBI in Breast Cancer Early Stage Breast Cancer (Stage 1-3), sponsored by British Columbia Cancer Agency. Recruiting at 1 site in Canada. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.

Sponsored by British Columbia Cancer Agency · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
40 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Breast Neoplasms by British Columbia Cancer Agency — 4 open to participants now, 6 under way, none of them phase 3. Breast Neoplasms · British Columbia Cancer Agency.

Planned enrollment
8th of 17
60 · median 50
Started
2026
the only one that year
No phase
10 of 20
2 open now
Registered
19th of 20
by date

Among the 20 studies in Breast Neoplasms by British Columbia Cancer Agency, this one is the 8th largest by planned enrollment of the 17 interventional ones that give a count, is the only one that started in 2026, is one of 10 with no phase, and was the 19th registered.

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

4 of the 20 studies in Breast Neoplasms by British Columbia Cancer Agency are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.

This study: 40 Years and older · female · no healthy volunteers.

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This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 20 studies in Breast Neoplasms by British Columbia Cancer Agency, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

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

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04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Female participants age 40 or older
  • Able to provide
  • 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
  • (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 (POCBP) within 4 weeks of RT start date

Exclusion criteria

Exclusion Criteria:

  • History of non-breast 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
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study 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.

    Radiation: Multiple Fraction PBI

  • 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.

    Radiation: Single Fraction PBI

Interventions

  • RadiationMultiple Fraction PBI

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

  • RadiationSingle Fraction PBI

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 years

Secondary outcomes

  1. Time from CT simulation to plan approval

    Measured as the time from the day of CT simulation to the date of plan approval.

    Time frame: Baseline

  2. 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

    Time frame: 6 weeks, 6 months, 12, months, 18 months, and 24 months post-treatment

  3. 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.

    Time frame: Baseline, 6 weeks, 6 months, 12 months, 18 months, and 24 months post treatment

  4. 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.

    Time frame: Baseline, 6 weeks, 6 months, 12 months, 18 months, and 24 months post treatment

  5. Participant-reported toxicities

    Occurrences of adverse events as measured by PRO-CTCAE

    Time frame: Baseline, 6 weeks, 6 months, 12, months, 18 months, and 24 months post-treatment

  6. Overall Survival (OS)

    Time from randomization to death from any cause, or last follow-up, whichever occurs first.

    Time frame: Approximately at the end of year 2 (study completion)

  7. Progression-Free Survival (PFS)

    Time from randomization to disease progression at any site, death, or last follow-up, whichever occurs first.

    Time frame: 6 weeks, 6 months, 12 months, 18 months, and approximately at the end of 24 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Dec 2029, 42 months after the start.

Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 42 months is above that.

Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 14, 2025
First posted
Mar 20, 2025
StartActual
Jun 8, 2026
Primary completionEst.
Dec 31, 2029
CompletionEst.
Dec 31, 2029
Last update
Aug 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06885671
Responsible party
Sponsor
First posted
Mar 20, 2025
Start date
Jun 8, 2026
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Aug 26, 2026

Study contacts

Robert Olson, MD, MSC, FRCPC
Contact
rolson2@bccancer.bc.ca
250-645-7300
Lindsay Mathews
Contact
lindsay.mathews@bccancer.bc.ca
250-645-7300
Robert Olson, MD, MSc, FRCPC
principal investigator · BC Cancer - Prince George

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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