Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-positive status confers therapeutic sensitivity to Cyclophosphamide, Doxorubicin, Fluorouracil, Paclitaxel, Pertuzumab, Trastuzumab in patients with Invasive Breast Carcinoma.
The European Medicines Agency (EMA) has authorized pertuzumab in combination with trastuzumab and chemotherapy for the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. This indication is based on APHINITY (BO25126), a multicenter, randomized, double-blind, placebo-controlled phase 3 trial. Investigators selected one of the following chemotherapy regimes: (i) 3 or 4 cycles of FEC or 5-fluorouracil, doxorubicin and cyclophosphamide (FAC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel; (ii) 4 cycles of AC or epirubicin and cyclophosphamide (EC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel; or (iii) 6 cycles of docetaxel in combination with carboplatin.
This statement is based on a regulatory approval from the European Medicines Agency:
Perjeta is indicated for use in combination with trastuzumab and chemotherapy in the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence.