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NCT05417516
A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
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.
Trial Details
NCT ID NCT05417516
Phase PHASE3
Sponsor Ontario Clinical Oncology Group (OCOG)
Status RECRUITING
Cancer Type Breast Cancer
Interventions Whole Breast Irradiation (WBI) Partial Breast Irradiation (PBI)
Locations (sample) Darlinghurst, New South Wales, Australia|-33.87939,151.21925 Hurstville, New South Wales, Australia|-33.9677,151.10149 North Sydney, New South Wales, Australia|-33.839,151.2072 Bundaberg, Queensland, Australia|-24.86621,152.3479 Southport, Queensland, Australia|-27.96724,153.39796
Key Eligibility Criteria
For inclusion in this study, patients must fulfill all of the following criteria: Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease (see AJCC TNM Cancer Staging, A… 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 neg…
For full eligibility, visit ClinicalTrials.gov .
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