Adjuvant treatment of HER2-positive breast cancer

A method of adjuvant therapy for increasing invasive disease free survival (IDFS) at 3 years in patients with HER2-positive, node positive or hormone receptor negative, early breast cancer, comprising administering to said patients, following surgery:

• (a) anthracycline-based chemotherapy comprising:
• (i) 3 or 4 cycles of 5-fluorouracil+epirubicin+cyclophosphamide (FEC) or 5-fluorouracil+doxorubicin+cyclophosphamide (FAC);
• or
• (ii) 4 cycles of doxorubicin+cyclophosphamide (AC) or epirubicin+cyclophosphamide (EC);
• (b) following said anthracycline-based chemotherapy, pertuzumab, trastuzumab, and taxane-based chemotherapy, wherein:
• (i) pertuzumab and trastuzumab are each administered intravenously starting on Day 1 of a first taxane-containing cycle and administered for 52 weeks;
• (ii) an initial dose of pertuzumab is 840 mg followed every 3 weeks by 420 mg pertuzumab;
• (iii) an initial dose of trastuzumab is 8 mg/kg followed every 3 weeks by 6 mg/kg trastuzumab;
• and
• (iv) said taxane-based chemotherapy comprises 3 or 4 cycles of 75 mg/m2 and/or 100 mg/m2 docetaxel every 3 weeks or 12 cycles of 80 mg/m2 paclitaxel every week;
• and
• wherein said IDFS at 3 years from initial administration in said patients is increased compared to patients to whom anthracycline-based chemotherapy, taxane-based chemotherapy, and trastuzumab without pertuzumab are administered.