Therapeutic Response

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

Statements

Source and description
Phesgo (pertuzumab / trastuzumab) [product information]. EMA. 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.
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 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.
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.