This licence extension follows results from the randomised, open-label NOAH trial in patients with newly diagnosed locally advanced or inflammatory early breast cancer. Patients were randomised to receive either neoadjuvant chemotherapy (including both an anthracycline and a taxane) plus trastuzumab followed by adjuvant trastuzumab monotherapy (n=117), or neoadjuvant chemotherapy alone (n=118).
In the study, trastuzumab (8mg/kg loading dose followed by 6mg/kg every 3 weeks) was administered concurrently with 10 cycles of neo-adjuvant chemotherapy, consisting of:
- doxorubicin plus paclitaxel every 3 weeks for 3 cycles then;
- paclitaxel every 3 weeks for 4 cycles then;
- cyclophosphamide plus methotrexate plus 5-fluorouracil every 4 weeks for 3 cycles.
After surgery was completed, patients continued to receive 3-weekly cycles of trastuzumab to complete 1 year of treatment.
After a median follow-up of 3.2 years, the 3-year event-free survival was 71% in the trastuzumab plus chemotherapy group compared with 56% in the chemotherapy-only group.
Investigators observed total pathological complete response, defined as absence of invasive cancer in both breast and axillary nodes, in 38% of patients who received neoadjuvant chemotherapy plus trastuzumab compared with 19% of patients who received neoadjuvant chemotherapy alone (p=0.001).
Further Information: Roche Products Ltd