IBCSG 37-07/BIG 1-06 (Neo-ALTTO) 

DESIGN

This three-arm trial is comparing the efficacy and tolerability of neo-adjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus the combination of lapatinib plus trastuzumab plus paclitaxel given as neo-adjuvant treatment in HER2/ErbB2 over-expressing and/or amplified primary breast cancer.

Patients will be randomized to receive either:
- oral lapatinib (1500 mg daily) for 6 weeks
- trastuzumab (4 mg/kg iv load followed by 2 mg/kg iv weekly) for 6 weeks
- oral lapatinib (1000 mg daily) with trastuzumab (4 mg/kg iv load followed by 2 mg/kg weekly) for 6 weeks

After this "biological window", patients will continue on the same targeted therapy plus weekly paclitaxel 80 mg/m2 for a further 12 weeks, up to definitive surgery. After surgery, patients will receive three courses of adjuvant chemotherapy with FEC followed by the same targeted therapy as in the neo-adjuvant setting for a further 34 weeks. The planned total duration of the anti-HER2 therapy will be one year.