Clinical trial NCT06885671: Phase II Single Vs Hypofractionated Irradiation for Timely Access to Partial Breast Radiotherapy
Official title: Phase II Single Vs Hypofractionated Irradiation for Timely Access to Partial Breast Radiotherapy: SHIFT-PB
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Lead sponsor: British Columbia Cancer Agency
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 60
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a phase II randomized controlled trial, with the primary objective of testing the feasibility of randomizing participants to single vs multiple fraction partial breast irradiation (PBI) for early stage, node negative, breast cancer. Participants will be randomized 1:1 to 13Gy in 1 fraction vs 26 Gy in 5 fractions.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* Female participants age 40 or older
* Able to provide informed consent
* pTis-2 pN0 cM0 breast cancer less than 3 cm in maximum size
* 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

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.
* 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 lymph nodes \> 3 cm
* Positive surgical margins
* Surgical cavities lacking clear delineation
* Known germline BRCA1/2 mutation.
* Serious medical comorbidities precluding radiotherapy (e.g., connective tissue disorders such as lupus or scleroderma)
* Pregnant or breastfeeding

Primary outcomes:
measure: Number of participants accrued
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life assessed using the POSI-Breast questionnaire
timeFrame: Baseline, 2 weeks, 2 months, 6 months, 12 months, 18 months, and 24 months post treatment
measure: Rates of provider-rated toxicities: Occurrences of adverse events as measured by CTCAE
timeFrame: Baseline, 2 weeks, 2 months, 6 months, 12 months, 18 months, and 24 months post treatment
Other outcomes:
Locations:
Study officials:
affiliation: BC Cancer - Prince George
name: Robert Olson, MD, MSc, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: