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Recruiting

NCT Number: NCT06885671

Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy

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.

Recruiting

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Key information

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

BC Cancer - Prince George

Prince George, British Columbia, V2M 7E9, Canada

Location status: Recruiting

Location contact

Kaitlin Earl, BHSc

CONTACT

[email protected]

250-645-7300 ext. 687427

Robert A Olson, MD FRCPC MSc

PRINCIPAL_INVESTIGATOR

Robert Olson A Radiation Oncologist, MD FRCPC MSc

CONTACT

[email protected]

250-645-7300

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multiple Fraction PBI

Radiation

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

Single Fraction PBI

Radiation

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

Primary outcomes

  1. Number of participants accrued

    Time frame: 2 years

    Number of participants who sign consent to be randomized to 1 vs 5 fractions of radiotherapy for PBI over a 2 year period

Secondary outcomes

  1. Time from CT simulation to plan approval

    Time frame: Baseline

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

  2. 2-Year Local Control Rates

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

    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

  3. Quality of life assessed using the POSI-Breast questionnaire

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

    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.

  4. Rates of provider-rated toxicities: Occurrences of adverse events as measured by CTCAE

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

    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.

  5. Participant-reported toxicities

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

    Occurrences of adverse events as measured by PRO-CTCAE

  6. Overall Survival (OS)

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

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

  7. Progression-Free Survival (PFS)

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lindsay Mathews

CONTACT

[email protected]

250-645-7300

Robert Olson, MD, MSC, FRCPC

CONTACT

[email protected]

250-645-7300

Sponsors and collaborators

Lead sponsor

British Columbia Cancer Agency

Other

Registry information

Official study title

Phase II Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy: SHIFT-PB

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 20, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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