Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Conditions
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.
Interventions
RADIATIONMultiple Fraction PBI
Participants randomized to Arm 1 will receive PBI with a dose of 26 Gy in 5 daily fractions.
RADIATIONSingle Fraction PBI
Participants randomized to Arm 2 will receive PBI in a single fraction with a dose of 13 Gy.
Sponsors
British Columbia Cancer Agency
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants accrued | 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
| Measure | Time frame | Description |
|---|---|---|
| Time from CT simulation to plan approval | Baseline | Measured as the time from the day of CT simulation to the date of plan approval. |
| 2-Year Local Control Rates | 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 |
| Quality of life assessed using the POSI-Breast questionnaire | 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. |
| 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 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. |
| Participant-reported toxicities | Baseline, 6 weeks, 6 months, 12, months, 18 months, and 24 months post-treatment | Occurrences of adverse events as measured by PRO-CTCAE |
| Overall Survival (OS) | Approximately at the end of year 2 (study completion) | Time from randomization to death from any cause, or last follow-up, whichever occurs first. |
| Progression-Free Survival (PFS) | 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. |
Countries
Canada
Contacts
CONTACTRobert Olson, MD, MSC, FRCPC
CONTACTLindsay Mathews
PRINCIPAL_INVESTIGATORRobert Olson, MD, MSc, FRCPC
BC Cancer - Prince George
Outcome results
None listed