A Multicentre Registry Study of Permanent Breast Seed Implant (PBSI) for Early Stage Breast Cancers.
For early stage breast cancer, accelerated partial breast irradiation is an alternative
treatment option to whole breast irradiation after breast conserving surgery. Our group has
previously reported results of a Phase I/II study of permanent breast seed implant (PBSI)
using palladium-103 seeds as an alternative to whole breast radiotherapy for well selected
breast cancer patients. The procedure is realised in a single session under light sedation
and local freezing. After a median FU of 54 months no patients has recurred on a cohort of
67 patients, and acute of delayed side effect compared favourably to external beam
Yet this study was a single centre study and the sample size did not allow evaluating
appropriately the risk of serious adverse events (SAE). The current study propose evaluating
SAE on a multicentre and larger cohort of 420 patients.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Serious Adverse Events
Serious Adverse Events (SAE) is an unintended sign, symptom, or syndrome illness that occurs during the period of observation in the clinical study and that is life threatening or result in death. SAE will be coded using the NCI CTC V3.0 scale and corresponds to grade 4 or 5 signs or symptoms.
Initial and then yearly up to 5 years
Jean-Philippe Pignol, MD, PhD
Sunnybrook Health Sciences Centre
Canada: Health Canada