Herceptin licensed as neoadjuvant-adjuvant therapy in early breast cancer

The indications for Herceptin (trastuzumab) have been extended to include use in patients 65 years and younger in combination with neoadjuvant chemotherapy followed by adjuvant trastuzumab for HER2 positive early breast cancer, that is locally advanced (including inflammatory) or where tumours are more than 2cm in diameter.

Herceptin (trastuzumab) is also licensed for metastatic breast cancer and certain gastrointestinal tumours
Herceptin (trastuzumab) is also licensed for metastatic breast cancer and certain gastrointestinal tumours

Clinical study

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).

View Herceptin drug record

Further Information: Roche Products Ltd

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