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
APHINITY is coordinated by the Breast International Group (BIG) with the ICR-CTSU providing collaborative support in the UK.
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.
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, including contact details for the trial may be found on the BIG website.
Monthly accrual figures are available from the UKCRN Portfolio