Accelerated Partial Breast Irradiation for Early Breast Cancer

Breast Cancer Clinical Trial

Official title: A Multicentre Feasibility Study of Accelerated Partial Breast Irradiation Using Three-dimensional Conformal Radiation Therapy for Early Breast Cancer.

Status Completed

Clinical Trial Summary

Hypothesis:

In selected women with node-negative invasive breast cancer treated with breast conserving surgery, postoperative accelerated partial breast irradiation (APBI) limited to the region of the tumour bed delivered by 3-dimensional conformal radiation therapy (3D CRT) is technically feasible and reproducible with acceptable treatment toxicity, cosmetic outcome, and local control rate in a multicentre trial.

Clinical Trial Description

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 overall survival.

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.

Secondary objectives:

• 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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00418210
• Study type: Interventional
• Source: Trans-Tasman Radiation Oncology Group (TROG)
• Status: Completed
• Phase: N/A
• Start date: August 2007
• Completion date: August 20, 2018