ABCSG 39 / Aphinity

Status: Treatment Phase & Follow-up

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.

Coordinating Investigator: Günther Steger (Vienna)
Start of study: 10/2011 (global), 05/2012 (national)
Sample size: 4.800
Sponsor: Roche


Description and status:

The APHINITY trial included patients with newly diagnosed primary invasive, HER2-positive breast cancer in order to compare invasive Disease-Free Survival (IDFS) of patients randomized to receive chemotherapy plus one year of trastuzumab plus placebo or chemotherapy plus one year of trastuzumab plus pertuzumab. Study recruitment is closed globally and in Austria, a total of 52 patients could be included in the APHINITY study at 11 sites. The trial is currently in the follow-up phase. The results of the 3rd interim analysis on Overall Survival (OS) were presented at the Annual Meeting of the ”European Society of Medical Oncology”(ESMO) in a virtual plenary session in July 2022.

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