Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-positive status confers therapeutic sensitivity to Cyclophosphamide, Epirubicin, Fluorouracil, Paclitaxel, Pertuzumab, Trastuzumab in patients with Invasive Breast Carcinoma.
The European Medicines Agency (EMA) has authorized Phesgo (pertuzumab / trastuzumab) in combination with chemotherapy in 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, and placebo-cotrolled phase 3 trial conducted in 4804 patients with HER2-positive early breast cancer. Within this trial, investigators had the choice of one of the following chemotherapy regimens: 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 paclitaxell; 4 cycles of AC or epirubicin and cyclophosphamide (EC), followed by 3 or 4 cycles of docetaxel or 12 cycles of weekly paclitaxel; or 6 cycles of docetaxel in combination with carboplatin.
This statement is based on a regulatory approval from the European Medicines Agency:
Phesgo is indicated for use in combination with chemotherapy in the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence.