A Randomized Multicenter, Double-Blind, Placebo-Controlled Comparison of Chemotherapy Plus Trastuzumab Plus Placebo Versus Chemotherapy Plus Trastuzumab Plus Pertuzumab as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 29 Sep 2017
At a glance
- Drugs Pertuzumab (Primary) ; Carboplatin; Cyclophosphamide; Docetaxel; Doxorubicin; Epirubicin; Fluorouracil; Paclitaxel; Trastuzumab
- Indications Early breast cancer
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms APHINITY
- Sponsors Roche
- 29 Sep 2017 According to a Genentech media release, sBLA seeks to convert the current accelerated approval to full approval.
- 29 Sep 2017 According to a Genentech media release, based on the results of this trial, the US FDA has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review for Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer (EBC). The FDA is expected to make a decision on approval by January 28, 2018.
- 05 Jun 2017 Results published a Genentech media release.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History