Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that HER2-positive status confers therapeutic sensitivity to Cyclophosphamide, Docetaxel, Doxorubicin, Fluorouracil, Pertuzumab, Trastuzumab in patients with Invasive Breast Carcinoma.

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.

This statement is based on a regulatory approval from the Food and Drug Administration:

PERJETA is a HER2/neu receptor antagonist indicated for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.

Citation

Genentech, Inc. Perjeta (pertuzumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125409s124lbl.pdf. Revised January 2020. Accessed October 30, 2024. Genentech, Inc. Perjeta (pertuzumab) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf. Revised December 2017. Accessed October 6, 2026.

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Contributions

Date Contributor Description
2024-10-30 Van Allen lab Initial access of FDA approvals
2017-12-20 Food and Drug Administration Indication received traditional approval.