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
Treatment Modality:
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
Neoadjuvant radiotherapy provides unique insights into breast tumour immune microenvironment
