NEO-HYPORT: does neoadjuvant radiotherapy improve breast cancer outcomes? An open label, randomised, parallel group, superiority trial to compare the disease-free survival following neoadjuvant versus adjuvant hypofractionated radiotherapy in breast cancer (NEO-HYPORT)

In the setting of curative treatment of breast carcinoma, radiotherapy is usually administered after surgery (adjuvant radiotherapy). We intend to evaluate the impact of delivering radiation therapy prior to surgical intervention in the treatment of these patients. The NEO-HYPORT trial is designed as a randomised, controlled, parallel group, open-label, single-centre, superiority trial comparing neoadjuvant and adjuvant radiotherapy after neoadjuvant chemotherapy. The primary endpoint is 3-year disease-free survival. A secondary randomisation will evaluate two hypofractionated radiotherapy schedules (40 Gy / 15 fractions / 3 weeks vs 26 Gy / 5 fractions / 1 week) in the two settings. Conventionally radiation therapy is delivered following surgery as adjuvant radiation therapy. The reasons for the same have been manifold including the hypothesis that surgical wound healing following radiation therapy may be delayed. Various biological arguments and outcomes from the utilisation of neoadjuvant radiation in other tumour sites suggest that neoadjuvant radiation may provide superior disease control as compared to adjuvant radiation therapy. Emerging evidence on wound healing safety following radiotherapy to the breast is also reported. The NEO-HYPORT trial will provide high-quality evidence about the efficacy of neoadjuvant radiotherapy and establish the safety of ultra hypofractionated radiotherapy in this setting.