RESULTS
NB
RECRUITMENT
From the 1229 participants screened in the BEA study, 414 developed a 4–9% RAVI within 9 months of ANC, of which 125 (Median Age 55 years) were recruited and randomised into the PLACE Trial (see Figure With continued low rate per month recruitment, the Independent Data Monitoring Committee (IDMC) advised that, even if recuitment of 200 patients was achieved, the outcome of the study was unlikely to alter and accordingly the trial was closed to new participants. Follow‐up of patients in the trial continued until at least 2 years after trial entry (August 2018). Median follow‐up was 43 months for patients in the intervention group, and 41 months in the control group.Both groups were well matched for Body Mass Index (BMI), age, dominant arm, side of operation, smoking history, type of surgery and radiotherapy treatments. All patients underwent axillary clearance, 73 patients underwent mastectomy as surgical treatment and 70 patients breast conservation. Radiotherapy was given to Regional Nodes in 28 patients randomised to no sleeve and 27 to the sleeve application arm. Median follow‐up is 42 months (range 27.2–53.8) (see Table Demographics of PLACE patientsN = 7227.8 (17.2, 45.3)N = 6728.7 (16.9, 60.9)N = 7241 (27.2, 53.8)N = 6943 (35, 53)N = 644005 (3960, 5605)N = 604005 (1068, 6010)N = 6415 (15, 25)N = 6015 (4, 30)
SCF radiotherapy to supraclavicular fossa nodal area.WLE (Wide Local excision).ANC (Axillary Node Clearance). NB not all patients underwent radiotherapy or adjuvant chemotherapy. Numbers (percentages undergoing treatment).