BIG4-11 APHINITY

A randomised, multicentre, 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+ primary breast cancer.

Disease site: Breast cancer

Status: Closed

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

ISRCTN: N/A

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

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