Therapeutic Response

HER2-positive status confers therapeutic sensitivity to Cyclophosphamide in combination with Doxorubicin, Paclitaxel, Pertuzumab, and Trastuzumab in patients with Invasive Breast Carcinoma.

Statements

Source and description
Perjeta (pertuzumab) [product information]. EMA. The European Medicines Agency (EMA) has authorized pertuzumab in combination with trastuzumab and 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.
Phesgo (pertuzumab / trastuzumab) [product information]. EMA. 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.
Perjeta (pertuzumab) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to pertuzumab in combination with trastuzumab and chemotherapy for the neoadjuvant treatment patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. This indication is based on Berenice (NCT02132949), a two-arm randomized study where HER2-positive was defined as a score of 3+ IHC or ISH amplification ratio of 2.0 or greater, as determined by a central laboratory. Patients received two potential chemotherapy regimens as part of the combination therapy: cyclophosphamide, doxorubicin, and paclitaxel; or cyclophosphamide, docetaxel, epirubicin, and 5-fu.
Perjeta (pertuzumab) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to pertuzumab in combination with trastuzumab and chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. This indication is based on Aphinity (NCT01358877) a multicenter, randomized, double-blind, placebo-controlled study where patients received one of the following anthracycline-based or non-anthracycline-based chemotherapy regimens: (1) cyclophosphamide, epirubicin, docetaxel, 5-fu; (2) cyclophosphamide, epirubicin, paclitaxel, 5-fu; (3) cyclophosphamide, doxorubicin, docetaxel, 5-fu; (4) cyclophosphamide, doxorubicin, paclitaxel, 5-fu; (5) doxorubicin, cyclophosphamide, docetaxel; (6) epirubicin, cyclophosphamide, docetaxel; (7) doxorubicin, cyclophosphamide, paclitaxel; (8) epirubicin, cyclophosphamide, paclitaxel; (9) carboplatin, docetaxel.
Phesgo (pertuzumab and trastuzumab) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to Phesgo (pertuzumab and trastuzumab) in combination with chemotherapy for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer. This indication is based on Berenice (NCT02132949), a two-arm randomized study where HER2-positive was defined as a score of 3+ IHC or ISH amplification ratio of 2.0 or greater, as determined by a central laboratory. Patients received two potential chemotherapy regimens as part of the combination therapy: cyclophosphamide, doxorubicin, and paclitaxel; or cyclophosphamide, docetaxel, epirubicin, and 5-fu. The FeDeriCa study (NCT03493854) demonstrated comparable pharmacokinetics and safety profiles between Phesgo and intravenous pertuzumab and intravenous trastuzumab.
Phesgo (pertuzumab and trastuzumab) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to Phesgo (pertuzumab and trastuzumab) in combination with chemotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. This indication is based on Aphinity (NCT01358877) a multicenter, randomized, double-blind, placebo-controlled study where patients received one of the following anthracycline-based or non-anthracycline-based chemotherapy regimens: (1) cyclophosphamide, epirubicin, docetaxel, 5-fu; (2) cyclophosphamide, epirubicin, paclitaxel, 5-fu; (3) cyclophosphamide, doxorubicin, docetaxel, 5-fu; (4) cyclophosphamide, doxorubicin, paclitaxel, 5-fu; (5) doxorubicin, cyclophosphamide, docetaxel; (6) epirubicin, cyclophosphamide, docetaxel; (7) doxorubicin, cyclophosphamide, paclitaxel; (8) epirubicin, cyclophosphamide, paclitaxel; (9) carboplatin, docetaxel. The FeDeriCa study (NCT03493854) demonstrated comparable pharmacokinetics and safety profiles between Phesgo and intravenous pertuzumab and intravenous trastuzumab.
Pertuzumab and Trastuzumab and Chemotherapy Therapy - 21 day cycle. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved pertuzumab in combination with trastuzumab and chemotherapy for the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. According to the EMA product information for this indication, 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.