MO39196 - Atezolizumab In Previously Untreated Breast Cancer
Research type
Research Study
Full title
MO39196 - A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH PACLITAXEL COMPARED WITH PLACEBO WITH PACLITAXEL FOR PATIENTS WITH PREVIOUSLY UNTREATED INOPERABLE LOCALLY ADVANCED OR METASTATIC TRIPLE NEGATIVE BREAST CANCER
IRAS ID
225621
Contact name
David Miles
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2016-004024-29
Duration of Study in the UK
4 years, 6 months, 31 days
Research summary
Breast cancer (BC) is the second most common cancer in the world, and by far the most frequent cancer among women both in more and less developed regions. It is ranked as the fifth cause of death from cancer overall in the world and is the leading cause of cancer-related deaths in women.
Overall, approximately 15%–20% of breast cancers are classified as Triple-negative breast cancers (TNBC) which are more likely to be aggressive and have a high proliferative rate. Patients with metastatic TNBC exhibit a poor clinical outcome with a median overall survival (OS) of less than 1 year.
Although TNBC may respond to chemotherapy, there are currently no approved targeted therapies for patients with this subtype cancer. In general, anthracycline-based combination therapy and taxanes such as paclitaxel are believed to show the greatest activity in metastatic breast cancer. Taxanes are now the most commonly used agent, particularly in the front-line setting.
Atezolizumab, an experimental Ig G1 monoclonal antibody, is an immunotherapy drug with anti-tumour activity in a number of solid tumours including TNBC.This study is designed to evaluate the efficacy and safety of atezolizumab administered in combination with paclitaxel, compared with placebo in combination with paclitaxel in patients with previously untreated, inoperable locally advanced or metastatic, centrally confirmed TNBC.
A total of approximately 495 patients are planned to be randomised at approximately 200 sites globally.
Patients will be randomised to receive atezolizumab or placebo IV infusions on Days 1 and 15 of every 28-day cycle, plus paclitaxel administered via IV infusion on Days 1, 8, and 15 of every 28-day cycle.
In the absence of disease progression or unacceptable toxicity, study treatment will be administered for a target of at least 6 cycles, with no maximum and will continue until the end of the study (EOS; defined as last patient last visit, or LPLV). In the absence of disease progression, paclitaxel and atezolizumab/placebo may be discontinued for toxicity independently of each other, with the other treatment being continued.There will be approximately 19 patients recruited at 5 UK sites
The study is sponsored by F. Hoffman La Roche
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
17/EM/0238
Date of REC Opinion
15 Aug 2017
REC opinion
Further Information Favourable Opinion