A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2) (NCT05417516) | Clinical Trial Compass
RecruitingPhase 3
A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
Australia910 participantsStarted 2023-11-20
Plain-language 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.
Who can participate
Age range50 Years – 120 Years
SexFEMALE
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
✕. Evidence of a DCIS component \> 3cm
✕. Lobular carcinoma only.
✕. More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).
What they're measuring
1
Local Recurrence
Timeframe: Annually for 5 years post-randomization