Efficacy and Safety of ABP980 Compared to Trastuzumab in Breast Cancer
Research type
Research Study
Full title
A Randomized, Double-Blind, Phase 3 Study Evaluating the Efficacy and Safety of ABP 980 Compared with Trastuzumab in Subjects with HER2 Positive Early Breast Cancer
IRAS ID
121971
Contact name
Karen McAdam
Contact email
Sponsor organisation
Amgen Inc
Eudract number
2012-004319-29
ISRCTN Number
n.a
Clinicaltrials.gov Identifier
n.a
Research summary
The present study is a multicentre, multinational, randomised, double-blind, study to compare the treatment effects of ABP 980 with Trastuzumab in patients with HER2 positive early breast cancer.
Breast cancer is the most common malignancy in women and is the leading cause of cancer-related death in European women. In 2010, breast cancer was responsible for 11,633 deaths in the UK. HER2-positive breast cancer tests positive for a protein called human epidermal growth factor receptor 2 (HER2), which promotes the growth of cancer cells. HER2-positive breast cancers tend to be more aggressive than other types of breast cancer.There is an ongoing need for new and improved treatment options for patients.
The purpose of the study is to compare the safety and efficacy of ABP 980 with trastuzumab (Herceptin®) in women with early breast cancer as a therapy in combination with chemotherapy. ABP 980 has been developed as a biosimilar to Herceptin® (trastuzumab) meaning the medications are nearly identical. The main objective of this trial is to demonstrate biosimilarity of ABP 980 to trastuzumab. Subjects will be randomised in a 1:1 ratio to receive either ABP 980 or trastuzumab plus paclitaxel during what is called the neoadjuvant treatment phase, or pre-treatment phase.Eligible patients will receive a run-in (pre-treatment) chemotherapy consisting of epirubicin and cyclophosphamide every 3 weeks followed by the randomisation into treatment with either ABP 980 or trastuzumab. Surgery will be completed 3 to 7 weeks after the last dose of study medication and disease status will be analysed. Following surgery, subjects will receive ABP 980 or trastuzumab for up to one year. This is called the Adjuvant Treatment Phase.
This study will be carried out at approximately 120 hospitals with approximately 588 patients that will be invited to participate.
The study is scheduled to last up to 34 months with approximately 16 months for treatment and consists of the Neoadjuvant Phase, Surgery, and the Adjuvant Treatment Phase.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
13/EE/0069
Date of REC Opinion
3 May 2013
REC opinion
Further Information Favourable Opinion