MO39193 - Atezolizumab + Chemotherapy in early relapsing TNBC
Research type
Research Study
Full title
A PHASE III, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTRE STUDY OF THE EFFICACY AND SAFETY OF ATEZOLIZUMAB PLUS CHEMOTHERAPY FOR PATIENTS WITH EARLY RELAPSING RECURRENT (INOPERABLE LOCALLY ADVANCED OR METASTATIC) TRIPLE-NEGATIVE BREAST CANCER
IRAS ID
236716
Contact name
Peter Schmid
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2016-005119-42
Duration of Study in the UK
3 years, 2 months, 26 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.
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 (mTNBC) exhibit a poor clinical outcome with a median overall survival (OS) of between 13 months and 17.5 months in patients treated with various chemotherapy agents.
Although TNBC may respond to chemotherapy, including taxanes, relatively few new agents have been approved for the subset of patients with mTNBC and there are no targeted therapies with widespread global approval available for patients with this specific subtype of breast cancer. Despite striking discoveries and a broad therapeutic armamentarium, mBC remains incurable. The goal of treatment of mBC is to prolong survival and to improve quality of life by mitigating cancer-related symptoms without increasing toxicity. Therefore, there is a pressing need for clinically active agents for mTNBC.Immune checkpoint inhibitors have demonstrated promising early activity as single agent therapy and in combination with chemotherapy in mTNBC. The aim of this study is to evaluate the efficacy and safety of the immune checkpoint inhibitor atezolizumab plus chemotherapy compared with placebo plus chemotherapy in patients with inoperable recurrent TNBC.
It is planned that approximately 350 patients will be randomised to this study globally. There will be approximately 19 patients recruited at 9 UK sites
Patients with early relapsing recurrent (inoperable locally advanced or metastatic) triple-negative breast cancer who meet the inclusion/exclusion criteria will be eligible to take part in this study.
Eligible patients will be randomised to receive atezolizumab with chemotherapy (Arm A) or placebo with chemotherapy (Arm B). For each patient, chemotherapy (carboplatin/gemcitabine or capecitabine) will be selected by the investigator prior to randomisation; however, capecitabine will be mandatory for patients who have received prior platinum therapy for the treatment of their early BC.
Study treatment will be delivered as follows:
Arm A
Atezolizumab by IV infusion on day 1 of each 3-week treatment cycle with either:
Gemcitabine followed by carboplatin, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle.
Or
Capecitabine twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle.
Arm B
Placebo by IV infusion on day 1 of each 3-week treatment cycle with either:
Gemcitabine followed by carboplatin, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle.
Or
Capecitabine twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle.
Study treatment will continue until disease progression, unacceptable toxicity, or patient or investigator decision to discontinue treatment.This is an event driven study. Study recruitment is expected to occur over approximately 17.5 months. The actual length of the study will depend on the actual recruitment rate and the number of events that occur.
The study is sponsored by F. Hoffmann-La Roche
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/0149
Date of REC Opinion
15 Feb 2018
REC opinion
Favourable Opinion