Randomised Trial Testing Intensity Modulated and Partial Organ Radiotherapy After Breast Conservation Surgery for Early Breast Cancer
- To test partial breast radiotherapy using intensity-modulated techniques following
complete local tumor excision in women with low-risk, early stage breast cancer.
OUTLINE: This is a multicenter study.
Patients are stratified according to center (not participating in sub-studies vs
participating in sub-studies). Patients are randomized to 1 of 3 treatment arms.
- Arm I (control): Patients undergo standard whole breast radiotherapy once daily on days
1-5 (15 fractions) for 3 weeks.
- Arm II: Patients undergo reduced whole breast radiotherapy (15 fractions) and standard
partial breast radiotherapy (15 fractions) once daily on days 1-5 for 3 weeks.
- Arm III: Patients undergo standard partial breast radiotherapy once daily on days 1-5
(15 fractions) for 3 weeks.
All patients complete a family history questionnaire at baseline. Patients also undergo
blood sample collection at baseline and paraffin-embedded tissue collection at follow-up for
molecular studies analyzing inter-patient variation by microarrays.
Patients in centers participating in sub-studies undergo quality of life and health economic
assessment at baseline, 6 months, and 1, 2, and 5 years. These patients also undergo
photographic assessment at baseline, 2 years, and 5 years.
After completion of study treatment, patients are followed for 10 years.
Allocation: Randomized, Primary Purpose: Treatment
Local tumor control in the ipsilateral breast (i.e., true recurrence plus new primary tumor) as confirmed by cytological or histological assessment
John R. Yarnold, MD, FRCR
Royal Marsden NHS Foundation Trust