Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-positive status confers therapeutic sensitivity to Docetaxel, Pertuzumab, Trastuzumab in patients with Invasive Breast Carcinoma.
The European Medicines Agency (EMA) has authorized Phesgo (pertuzumab / trastuzumab) in combination with chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. This indication is based on BERENICE (WO29217), a nonrandomized, open-label, multicenter, multinational, phase 2 clinical study where the treatment regimes were either (i) doxoruicin and cyclophosphamide followed by pertuzumab in combination with trastuzumab and paclitaxel or (ii) pertuzumab in combination with trastuzumab and docetaxel.
This statement is based on a regulatory approval from the European Medicines Agency:
Phesgo is indicated for use in combination with chemotherapy in the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence.