Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy

NCT06885671 | Not Yet Recruiting DMC

• 1 other identifier: SHIFT-PB
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Outcome Measures

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

  2 years

Secondary Outcomes (7)

• Time from CT simulation to plan approval

  Baseline

• 2-Year Local Control Rates

  6 weeks, 6 months, 12, months, 18 months, and 24 months post-treatment

• Quality of life assessed using the POSI-Breast questionnaire

  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

  Baseline, 6 weeks, 6 months, 12 months, 18 months, and 24 months post treatment

• Participant-reported toxicities

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

Study Arms (2)

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.

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.

Radiation: Single Fraction PBI

Interventions

Multiple Fraction PBI RADIATION

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

Multiple Fraction PBI (Arm 1)

Single Fraction PBI RADIATION

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

Single Fraction PBI (Arm 2)

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Eligible participants must be biologically female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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.
• Inability to meet mandatory planning constraints.
• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Related Publications (1)

• 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 DERIVED

Study Officials

• Robert Olson, MD, MSc, FRCPC

  BC Cancer - Prince George

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Olson, MD, MSC, FRCPC

CONTACT

250-645-7300; rolson2@bccancer.bc.ca

Lindsay Mathews

CONTACT

250-645-7300; lindsay.mathews@bccancer.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 17, 2025

Record last verified: 2025-11