Breast Neoplasm Female, Cosmetic Outcome, Radiotherapy
Conditions
Brief summary
The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.
Detailed description
This is a randomized, two-arm, single blinded trial comparing two radiation treatment modalities, PBI and WBI. Following BCS or on the completion of additional adjuvant chemotherapy, eligible and consenting patients with newly diagnosed and histologically confirmed invasive carcinoma of the breast (without evidence of metastatic disease); with microscopically clear resection margins of 1mm (or no residual disease on re-excision) and negative axillary node involvement will be randomized in a 1:1 fashion to receive either PBI (experimental group) or WBI (control group). Study participants will receive 26Gy in 5 fractions in both treatment arms, treated once per day, for a period of 5-7 days. Study participants will not be made aware of treatment allocation to prevent any potential bias in their assessment of cosmesis. Stratification factors include tumour size, estrogen receptor (ER) status, and clinical centre.
Interventions
RADIATIONWhole Breast Irradiation (WBI)
The dose fractionation and prescription is 26Gy in 5 fractions to the PTV once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).
RADIATIONPartial Breast Irradiation (PBI)
The dose fractionation and prescription is 26Gy in 5 fractions to the PTV prescribed at the isocentre of the treatment fields treated once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).
Sponsors
Ontario Clinical Oncology Group (OCOG)
Canadian Institutes of Health Research (CIHR)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Study participants will be made unaware of treatment allocation to prevent any potential bias in their assessment of cosmesis.
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
For inclusion in this study, patients must fulfill all of the following criteria: 1. Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease (see AJCC TNM Cancer Staging, Appendix II). 2. Treated by BCS with microscopically clear resection margins \>= 1mm for invasive and non-invasive disease or no residual disease on re-excision. 3. Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection or clinical assessment with a negative axillary ultrasound and/or biopsy, for women with unifocal tumours \<= 2cm, histologic grade 1 or 2, ER or PR+ and HER2-ve that are being planned for endocrine therapy
Exclusion criteria
Patients who satisfy any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local Recurrence | Annually for 5 years post-randomization | Time from randomization to any evidence of tumour recurrence (invasive and non-invasive) in the treated breast. |
| Patient Assessment Cosmesis at 3 years | 3 and 5 years post-randomization | Cosmesis will be assessed by the patient using the Breast Cosmesis Questionnaire which incorporates the Modified EORTC Breast Cosmetic Rating System and the UK Patient Reported Outcomes Questions following BCS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distant Disease Free Survival (DDSF) | Annually for 5 years post-randomization. | Time from randomization to evidence of metastasis involving distant sites (e.g. bone, liver, lung, or brain). |
| Disease Free Survival (DFS) | Annually for 5 years post-randomization. | Time from randomization to local recurrence, regional or distant recurrence, contralateral breast cancer, other second cancer, or death. |
| Overall Survival | 3 years post-randomizaton. | Time from randomization to death of any cause. |
| Radiation Toxicity | 2 weeks and 3 months post-radiation treatment, then annually for 5 years post-randomization. | Acute (2 weeks and up to 3 months after completing RT) and late toxicity (beyond the 3 months after completing RT) will be assessed by clinical centre personnel using the NCI CTCAE version 5.0. |
| Nurse/Clinical Research Associate assessed cosmesis at 3 and 5 years. | 3 and 5 years post-randomization. | A nurse/Clinical Research Associate (CRA) assessment of cosmesis using the EORTC Breast Cosmetic Rating System. Nurses and CRAs will be training in assessing cosmesis using training slides and guide previously developed for other trials. |
| Patient Assessed Cosmesis at 5 years. | 5 years post-randomization. | Cosmesis will be assessed by the patient using the Breast Cosmesis Questionnaire which incorporates the Modified EORTC Breast Cosmetic Rating System13,27,42 and the UK Patient Reported Outcomes Questions following BCS. |
| Patient Reported Quality of Life | 2 weeks post-radiation treatment, then at 3 and 5 years post-randomization. | Patients will complete the EORTC Breast Cancer Quality of life questionnaire |
Countries
Australia, Canada
Contacts
CONTACTShelley Chambers, MA
CONTACTErin McGean
PRINCIPAL_INVESTIGATORTimothy Whelan, M.D.
Juravinski Cancer Centre and McMaster University
Outcome results
None listed