We at PGIMER have been practicing hypofractionated radiotherapy in breast cancer patients for the last 4 decades. Our standard doses have been 35Gy/15#/3wks to the chest wall after mastectomy and 40Gy/16#/3wks after breast conserving surgery (BCS).It is also a routine practice in the UK and in a few centers in Canada. Hypofractionation reduces treatment time to half while maintaining cosmesis and gives control rates equal to conventional fractionation. As breast cancer is a leading cancer in females and radiation therapy is an important part of its local management, hypofractionation helps radiation centers worldwide to meet the growing need for radiation treatment in breast cancer, particularly in developing countries where resources are limited. It also reduces the financial burden on the patient and family. In this study we want to evaluate the impact of reducing the treatment duration from 3 weeks to 1 week. Eligible patients with breast cancer after mastectomy or BCS will be treated with a radiotherapy dose of 26Gy in 5 fractions over 1 week in the study arm and 40Gy in 15 fractions over 2 weeks in the control arm. The primary endpoint of this noninferiority study will be locoregional tumour control. Secondary endpoints will be early and late radiation toxicities, quality of life, contralateral primary tumours, regional and distant metastases, survival and second cancers. A total of 1018 patients will be randomised (1:1) to receive 1 week or 2 weeks of radiotherapy. An event-driven analysis will be performed after at least 94 patients have documented locoregional recurrences.
Age ≥18 years
Female or male
Invasive carcinoma of the breast
Breast conserving surgery(BCS) with axillary clearance or total mastectomy with axillary clearance(TMAC); (reconstruction allowed but not with implant; tissue expanders with distant metal ports are allowed)
Supraclavicular node or internal mammary node or distant metastasis
Past history of malignancy except (i) basal cell skin cancer and CIN cervix uteri or(ii) non-breast malignancy allowed if treated with curative intent and at least 5 years disease free
Contralateral breast cancer, including DCIS, irrespective of date of diagnosis
Breast reconstruction using implants
Parallel
1 week RT
RadiationRT will be delivered over 1 week
2 week RT
RadiationRT will be delivered over 2 week
Loco-regional recurrence, Change is being assessed
disease recurrence in the ipsilateral chest wall or regional lymph nodes from the time of randomization until the end of follow-up.
Disease-free survival, Change is being assessed
locoregional recurrence, distant metastasis, or death from any cause from the time of randomisation until the end of follow-up.
Overall survival, Change is being assessed
death from any cause from the time of randomisation until the end of follow-up
Acute radiation toxicity
Any loco-regional toxicity assessed and scaled according to the RTOG grading system.
Late adverse events, Change is being assessed
Any adverse event occurring after 6 months of RT
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