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BIG 4-11 APHINITY

Comparison of single-versus-dual anti-HER2 therapy (trastuzumab, pertuzumab) for patients with HER2-positive primary breast cancer
 

SCIENTIFIC TITLE

A randomized, 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  

WHAT

APHINITY is testing whether adding a drug called pertuzumab to the standard adjuvant treatment (trastuzumab and chemotherapy) in patients with operable HER2-positive (HER+) primary breast cancer improves the outcome of patients with the disease. 

WHY / OBJECTIVES

Previous studies have shown that the use of the drug trastuzumab (Herceptin®) improves the chances of disease-free survival of patients with HER2+ breast cancer. This drug has been approved and licensed. It is now the standard of care to give trastuzumab along with chemotherapy after surgery for patients with HER2+ breast cancer.

However, up to 40% of patients with HER2+ breast cancer may become resistant to trastuzumab.

The aim of APHINITY is to investigate a new drug called pertuzumab, which also acts on the HER2 marker, but in a different way than trastuzumab, and to combine it with the current standard of care (chemotherapy and trastuzumab). This dual anti-HER2 therapy uses drugs that work in a complementary way and may improve treatment of this specific breast cancer subtype.  The hope is that this strategy can overcome the resistance to treatment that occurs in some patients when a single drug is used. 

WHO

Patients

Patients aged 18 and older, with known hormone receptor status (estrogen receptor [ER] and progesterone receptor [PgR]), and confirmed HER2+ breast cancer. This means that the cells have been tested positive for a protein called HER2.

A total of 4805 patients were recruited. 

WHO

Research Groups

 This study is conducted by BIG Headquarters, in collaboration with the Breast European Adjuvant Study Team (BrEAST) and Frontier Science Scotland (FSS), which serve respectively as independent data and statistical centres.
 

23 research groups from the BIG network are participating in this trial:
 

* Europe

          • ABCSG - Austrian Breast & Colorectal Cancer Study Group
          • AGO-B - Arbeitsgemeinschaft Gynäkologische Onkologie Breast Study Group
          • BOOG - Borstkanker Onderzoek Groep
          • CEEOG - Central and East European Oncology Group
          • DBCG - Danish Breast Cancer Cooperative Group
          • EORTC - European Organisation for Research and Treatment of Cancer
          • GBG - German Breast Group
          • GEICAM - Grupo Español de Investigación en Cáncer de Mama
          • GOIRC - Gruppo Oncologico Italiano di Ricerca Clinica
          • IBCSG - International Breast Cancer Study Group
          • Cancer Trials Ireland
          • ICR-CTSU - Institute of Cancer Research - Clinical Trials & Statistics Unit
          • NCRI-BCSG - National Cancer Research Institute - Breast Cancer Clinical Studies Group
          • SOLTI
          • SUCCESS Study  
          • SweBCG - Swedish Breast Cancer Group
          • UCBG - Unicancer Breast Group
          • WSG - Westdeutsche Studiengruppe

 

* Latin America

          • GAICO - Grupo Argentino de Investigación Clínica en Oncología
          • GECO-PERU - Grupo de Estudios Clinicos Oncologicos Peruano
          • GOCCHI - Chilean Cooperative Group for Oncologic Research

 

* Asia Pacific Region

          • ANZ BCTG - Australia & New Zealand Breast Cancer Trials Group
          • TCOG - Taiwan Cooperative Oncology Group

HOW

 Patients enrolled in APHINITY were randomly assigned to one of the following treatments: 

- Chemotherapy and trastuzumab combined with pertuzumab,

 OR

- Chemotherapy and trastuzumab with placebo.

 

The patients were treated forone year. The study will compare results between the two treatments, looking at the invasive disease free survival, overall survival, and safety.

 APHINITY_Study_Design.png

During the trial, samples (blood and tumour tissue) have been collected from all participating patients and stored in the study bioprepository for future research. This will help us identify biomarkers, which can help to:

- predict response or toxicity (side effects) of the dual anti-HER treatment

- better understand the biology of HER2+ tumours

- develop and validate diagnostic tests

WHEN

The last patient was recruited in August 2013.

All patients have completed their one year of treatment. They will be followed up for 10 years after the date the last patient was enrolled.

The first results of the study are expected to be available in early 2017.

WHERE

The trial is being conducted in 42 countries, with a total of 563 hospitals worldwide. 

290 of the participating hospitals are affiliated with the 23 participating BIG groups.

RELATED PUBLICATIONS


Not at present
 

FUNDING


The trial is fully funded by Roche (sponsor)
 


ClinicalTrials.gov identifier: NCT01358877
 


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