Duration of Trastuzumab with chemotherapy in women with early breast cancer: six months versus twelve

Research Summary

The incidence of breast cancer continues to rise in the Western Europe and US and breast cancer remains a major health problem despite considerable improvements in treatment of the disease both in the adjuvant and in the metastatic setting. Trastuzumab (Herceptin®) treatment in women with early breast cancer and HER2 positivedisease has proved a major advance and has demonstrated incontrovertibly the value of targeted therapy in the adjuvant setting for breast cancer in particular and cancer in general. However the use of 12 months trastuzumab in the majority of studies is not based on evidence. It is reasonable to consider that since the beneficial effect ofadjuvant trastuzumab is detected early in follow-up (median 1 year) that the majority of the adjuvant benefit results from the first 6 months of therapy. This hypothesis is supported by evidence from the FinHer study which with only 9 weeks trastuzumab demonstrates a similar-sized benefit to 12 months treatment when given concurrently withchemotherapy. The Persephone trial will compare 6 months treatment with 12 months in terms of efficacy and safety.

Research Overview
PI Name Rea - DW
Sponsor University of Cambridge
Project Status Open
Proposed End Date 01/06/2011
Study Run through CRF? No
Target number of patients agreed to recruit 4000
Recruitment so far 14