A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age50-120
SponsorOntario Clinical Oncology Group (OCOG)
About this trial
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.
Eligibility criteria
Qualifiers
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).
Treated by BCS with microscopically clear resection margins >= 1mm for invasive and non-invasive disease or no residual disease on re-excision.
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
Disqualifiers
Age less than 50 years.
Known to be BRCA 1 and/or BRCA 2 positive.
Tumour size >3cm in greatest diameter on pathological examination.
Evidence of extensive intraductal component (EIC) (defined as an invasive tumour with a ductal carcinoma in situ (DCIS) component comprising at least 25% and extending beyond the invasive component to surrounding normal breast tissue) with the following exception: smaller tumours with EIC where the combined size (of the invasive and DCIS components) are <= 3cm remain eligible
Trial design
Treatments tested in this trial
- Whole Breast Irradiation (WBI)
- Partial Breast Irradiation (PBI)
Treatment groups
910 Participants
are divided into 2 treatment groupsSponsors and collaborators
Ontario Clinical Oncology Group (OCOG)
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov