Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multiple Fraction PBI, Single Fraction PBI.
- Who it may be relevant to
- Registry conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3). Basic parameters: from 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase II Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy: SHIFT-PB
Overview
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.
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.
Interventions
- Radiation Multiple Fraction PBI
Participants randomized to Arm 1 will receive PBI with a dose of 26 Gy in 5 daily fractions. - Radiation Single Fraction PBI
Participants randomized to Arm 2 will receive PBI in a single fraction with a dose of 13 Gy.
Primary outcome measures
- Number of participants accrued [Time frame: 2 years]
Secondary outcome measures (7)
- Time from CT simulation to plan approval [Time frame: Baseline]
- 2-Year Local Control Rates [Time frame: 6 weeks, 6 months, 12, months, 18 months, and 24 months post-treatment]
- 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]
- 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 toxicities [Time frame: Baseline, 6 weeks, 6 months, 12, months, 18 months, and 24 months post-treatment]
- Overall Survival (OS) [Time frame: Approximately at the end of year 2 (study completion)]
- Progression-Free Survival (PFS) [Time frame: 6 weeks, 6 months, 12 months, 18 months, and approximately at the end of 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- BC Cancer - Prince George — Prince George
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. PMID 40781619
Identifiers
NCT: NCT06885671 · SHIFT-PB