WO29522 - A Study of MPDL3280A and Nab-paclitaxel in Breast Cancer
Research type
Research Study
Full title
A PHASE III, MULTICENTER, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF MPDL3280A (ANTI−PD-L1 ANTIBODY) IN COMBINATION WITH NAB-PACLITAXEL COMPARED WITH PLACEBO WITH NAB-PACLITAXEL FOR PATIENTS WITH PREVIOUSLY UNTREATED METASTATIC TRIPLE-NEGATIVE BREAST CANCER
IRAS ID
172183
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division, PDR
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2014-005490-37
Duration of Study in the UK
4 years, 1 months, 18 days
Research summary
Summary of Research
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 nab-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.
MPDL3280A, an experimental Ig G1 monoclonal antibody, is an immunotherapy drug with anti-tumour activity in a number of solid tumours including TNBC.
The primary aim of the study is to look at whether combining MPDL3280A with nab-paclitaxel offers a greater clinical benefit to patients with locally advanced or metastatic TNBC than treatment with nab-paclitaxel alone.
A total of 350 patients will take part in this study globally.
Patients will be randomly allocated to receive MPDL3280A or placebo plus nab-paclitaxel every 28-day cycle. In the absence of disease progression or unacceptable toxicity, nab-paclitaxel will be administered for a target of at least 6 cycles, with no maximum. Patients who receive immunotherapy drugs sometimes experience an increase in the size or number of their tumours before their disease starts to shrink. Therefore, upon initial apparent disease progression, patients who were receiving MPDL3280A + nab-paclitaxel arm may continue to receive open-label MPDL3280A with or without nab-paclitaxel until unacceptable toxicity or loss of clinical benefit, provided they meet certain conditions. Patients receiving placebo + nab-paclitaxel must discontinue study treatment upon determination of progressive disease.
There will be approximately 25 patients recruited at 5 UK sites
The study is sponsored by F. Hoffman La Roche
Summary of Results
Once the last participant has completed the clinical trial, Roche will analyze the combined results of the trial and create a report summarizing the results. The analysis of the data takes time; however Roche aims to make the summary of the outcome of the clinical trial available within 12 months after the last clinical trial participant has completed the trial. Roche may also provide a summary of trial outcome prior to the end of the clinical trial.
Below you can find the available results of the IMpassion130 clinical trial.https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbSgv9uUS1wsd00iFWSZyptH89w1tcscJeKmImtXTgMdp8hKctbjUfO5qj6yzVRx8pDD2zeGUgXkvtCf-2Byeu8oH0UUhpcvmB6-2FAgZ6lqdmKJzcdU4JT004hOcLMORbzbWUZscuAtqNw8-2FlMepUqPm9CHmbsZ7GDtB0JWm-2Fq-2BxBWEr67OU_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YJkrN7rZVySoXtKuBiUcAQFSEvwgPkfL80bGwjKNN9AG-2B94RlwiUJo-2FRuJhObMZ3NJuQZMKwaufnm-2BkEDT-2BFGZfEgHSWNTgJUAgxcHOcylkCgSaVVs9Y4xlBO8afe6-2FekW1yHZ4uq7zFxlpSBRSe9J8SWWGiitzx5Qe8SuzW3i-2B8w-3D-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7C5b1ff0a3ae8f4d3017d308da8b4fb7a6%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637975471740812506%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=A7sJ%2BSsXZEtjnNqCIg9jkvWAPMutgecVOodJ5hLi3eI%3D&reserved=0
REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/0834
Date of REC Opinion
18 May 2015
REC opinion
Favourable Opinion