Clinical trial · Interventional
Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy
Phase II Single vs Hypofractionated Irradiation For Timely Access to Partial Breast Radiotherapy: SHIFT-PB
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Early Stage Breast Cancer (Stage 1-3) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Multiple Fraction PBI | Radiation | — | UNRESOLVED |
| Single Fraction PBI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Multiple Fraction PBI (Arm 1)
- description
- For participants randomized to Arm 1, PBI will be delivered with a dose of 26 Gy in 5 daily fractions.
- interventionNames
- Radiation: Multiple Fraction PBI
- type
- EXPERIMENTAL
- label
- Single Fraction PBI (Arm 2)
- description
- For participants randomized to Arm 2, PBI will be delivered in a single fraction with a dose of 13 Gy.
- interventionNames
- Radiation: Single Fraction PBI
Primary outcomes (1)
- measure
- Number of participants accrued
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDOlson 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