Carcinoma, Ductal, Breast Clinical Trial
Official title:
A Randomised Phase III Study of Radiation Doses and Fractionation Schedules in Non-low Risk Ductal Carcinoma In Situ (DCIS) of the Breast
Hypotheses: 1. The addition of tumour bed boost after BCS in women with non-low risk DCIS reduces the risk of local recurrence (invasive or intraductal recurrence in the ipsilateral breast). 2. The risk of local recurrence in the shorter fractionation arm is not worse than that for the standard fractionation arm. 3. A molecular signature predictive of invasive recurrence of DCIS will be detectable and the molecular signature may eventually have clinical utility for therapy individualization. Overall Objectives: 1. To improve the outcome of women with non-low risk DCIS treated with breast conserving therapy. 2. To individualize treatment selection for women with DCIS to achieve long term disease control with minimal toxicity.
Specific objectives: 1. To evaluate time to local recurrence in women with DCIS treated with breast conserving surgery followed by: - whole breast RT alone versus whole breast RT plus tumour bed boost; - RT using the standard fractionation schedule versus the shorter schedule. 2. To evaluate time to disease recurrence and overall survival in women with DCIS treated with breast conserving surgery followed by: - whole breast RT alone versus whole breast RT plus tumour bed boost; - RT using the standard fractionation schedule versus the shorter schedule. 3. To compare the toxicity of: - whole breast RT alone versus whole breast RT plus tumour bed boost; - RT using the standard fractionation schedule versus the shorter schedule. 4. To compare the cosmetic outcome of: - whole breast RT alone versus whole breast RT plus tumour bed boost; - RT using the standard fractionation schedule versus the shorter schedule. 5. To identify a molecular signature predictive of invasive recurrence of DCIS to facilitate therapy individualization. 6. To assess inter-relationship of biomarkers and relationship between biomarker expression and specific histopathologic features of DCIS. 7. To evaluate the quality of life of women treated with: - whole breast RT alone versus whole breast RT plus tumour bed boost; - RT using the standard fractionation schedule versus the shorter schedule. ;
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