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A randomised 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

Disease site: Breast cancer

Treatment modality: Combination therapy

Status: In active follow-up  

Trial details

APHINITY is coordinated by the Breast International Group (BIG) with the ICR-CTSU providing collaborative support in the UK.

Primary objectives:

To compare invasive disease-free survival (IDFS) in patients with HER2-positive breast cancer randomized to chemotherapy plus one year of trastuzumab plus placebo or chemotherapy plus one year of trastuzumab plus pertuzumab.

Secondary objectives:

To compare invasive disease-free survival including second non-breast cancers, disease-free survival (DFS), overall survival (OS), recurrence-free interval (RFI), distant recurrence-free interval (DRFI), cardiac safety, overall safety and health-related quality of life (HRQL) in the two treatment arms.

Chief Investigator: Professor David Cameron, Edinburgh University (UK CI)

ICR-CTSU Scientific Lead: Professor Judith Bliss


Sponsor: F. Hoffman-La Roche Ltd and Genentech, Inc.

Funder: F. Hoffman-La Roche Ltd

Further information

Further information, including contact details for the trial may be found on the BIG website.

Monthly accrual figures are available from the UKCRN Portfolio

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.