The HERA Trial: Final Analysis Results

Overview

The HERceptin Adjuvant (HERA) trial is an adjuvant trial comparing observation vs one year of Herceptin® vs two years of Herceptin® in women with early stage HER2-positive breast cancer. The study was sponsored by Roche. FSS has worked with the Breast International Group (BIG) and the Coordinating Group, BrEAST, on many aspects of trial management for HERA including data quality control and the statistical analysis of the data.

Results from the HERA Trial showed that 1 year of adjuvant trastuzumab after chemotherapy for patients with HER2-positive early breast cancer significantly improves long-term disease-free survival, compared with observation.

Title of Publication

11 years’ follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial.

Authors

David Cameron, Martine J Piccart-Gebhart, Richard D Gelber, Marion Procter, Aron Goldhirsch, Evandro de Azambuja, Gilberto Castro Jr, Michael Untch, Ian Smith, Luca Gianni, Jose Baselga, Nedal Al-Sakaff, Sabine Lauer, Eleanor McFadden, Brian Leyland-Jones, Richard Bell, Mitch Dowsett, and Christian Jackisch for the Herceptin Adjuvant (HERA) Trial Study Team

Publication Reference

The Lancet | Volume 389 | Issue Number 10075 | Pages 1195-1205 | 16 February 2017

APHINITY | European Journal of Cancer (EJC)

Mar 18, 2022

Six-year absolute invasive disease-free survival benefit of adding adjuvant pertuzumab to trastuzumab and chemotherapy for patients with early HER2-positive breast cancer: A Subpopulation Treatment Effect Pattern Plot (STEPP) analysis of the APHINITY (BIG 4-11) trial

APHINITY | AACR Cancer Research

Feb 15, 2022

Effect of young age at diagnosis on clinical outcomes and efficacy of anti-HER2 targeted therapy in patients with HER2-positive early breast cancer: Results from the APHINITY trial.

The ALTTO Trial: Updated Results from the international phase III ALTTO trial (BIG2-06/Alliance N063D)

May 1, 2021

Presentation of the pre-specified analyses of >5-years follow-up of the Phase III ALTTO trial as shown at the 2017 annual meeting of the American Society of Clinical Oncology and published in the European Journal of Cancer in 2021.

The APHINITY Trial: Results of the Interim Overall Survival Analysis at 6 years’ follow-up

May 1, 2021

The JCO confirms the invasive disease-free survival benefit from adding pertuzumab to standard adjuvant therapy for patients with node-positive HER2-positive early breast cancer.

A pooled analysis of the Cardiac Events in three adjuvant trials: HERA, NSBAP B-31, and NCCTG 9831 (Alliance Trials)

Jan 1, 2020

Breast Cancer Research and Treatment published that Adjuvant trastuzumab should be considered a safe treatment from a cardiac standpoint for most patients. Further research is needed to individualize prevention and management of trastuzumab-associated cardiotoxicity.

The APHINITY Trial: Results of the Primary Analysis

Jul 13, 2017

An article published in the New England Journal of Medicine (NEJM) reports that pertuzumab, when added to chemotherapy and trastuzumab, significantly improved the rates of invasive-disease–free survival among patients with HER2-positive early breast cancer.