A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation Using Three-dimensional Conformal Radiation Therapy for Early Breast Cancer.
This is a TROG multicentre feasibility study of APBI using 3D CRT in selected women with
node-negative breast cancer treated by breast conserving surgery with negative margins.
This is a one-arm feasibility study in which the primary endpoint is the feasibility rate
for APBI using 3D CRT. This is defined as the proportion of eligible patients treated
without a major protocol deviation. Secondary endpoints include radiation toxicity, cosmetic
outcome, quality of life, time to ipsilateral breast recurrence, disease-free survival, and
Primary objectives: To evaluate the technical feasibility and reproducibility of APBI
limited to the region of the tumour bed using 3D CRT following breast conserving surgery.
- To assess the acute and long term toxicity of APBI using 3D CRT.
- To examine the cosmetic outcome of women with breast cancer treated by breast
conserving surgery and APBI using 3D CRT.
- To determine the time to ipsilateral breast recurrence, disease free survival and
overall survival of women with node-negative breast cancer completely resected by
breast conserving surgery followed by APBI using 3D CRT.
- To assess the quality of life of women with node-negative breast cancer treated by
breast conserving surgery and APBI using 3D CRT.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility rate of APBI using 3D conformal radiation therapy
First analysis will occur 6 months after accrual of all patients (approximately 1.5 years after start of trial)
Peter MacCallum Cancer Centre, Australia
Australia: Human Research Ethics Committee