Phase 2 study of Cobimetinib in TNBC
Research type
Research Study
Full title
A MULTISTAGE, PHASE II, STUDY EVALUATING THE SAFETY AND EFFICACY OF COBIMETINIB IN COMBINATION WITH PACLITAXEL AS FIRST-LINE TREATMENT FOR PATIENTS WITH METASTATIC TRIPLE-NEGATIVE BREAST CANCER
IRAS ID
162695
Contact name
Tamas Frederick Gordon Hickish
Contact email
Sponsor organisation
F. Hoffman-La Roche Ltd.
Eudract number
2014-002230-32
Duration of Study in the UK
3 years, 1 months, 29 days
Research summary
Research Summary
Breast cancer is the most common invasive malignancy and the most common cause of cancer-related mortality in women. Metastatic triple-negative breast cancer (TNBC) remains an incurable disease for which no targeted therapies are available and chemotherapy is the only active treatment. Most patients develop rapid resistance to chemotherapy, which leads to fast relapse of disease and short overall survival. This is a population with a high unmet need.
The study drug Cobimetinib will be used in combination with Paclitaxel (an approved agent with extensive safety data available and has shown to be a safe and active treatment for metastatic breast cancer). It’s a potent and highly selective inhibitor of the pathway that leads to the generation of tumour cells. It’s also anticipated that it will prevent resistance developing. Studies have demonstrated tumour regression and with over 500 cancer patients treated to date, the safety profile of cobimetinib has been well characterised at the proposed dose and schedule in this study.
Participants who provide written consent and meet eligibility criteria will be randomly assigned in a 1:1 ratio to two treatment arms: cobimetinib & paclitaxel and placebo & paclitaxel.
The study will be conducted in two phases: an initial safety run-in open label stage of approximately 12 patients followed by an expansion stage with approximately 100 patients.
The enrollment period for both stages of the study is estimated to be approximately 14 months. Patients will be monitored for adverse events, changes in laboratory values, and physical examination findings.
The study will end when all patients enrolled have been followed up or the sponsor ends the study. Patients may continue on study treatment until the development of progressive disease, unacceptable toxicity, and/or consent withdrawal.
This study involves procedures including- Physical exams, Ophthalmologic Exams, ECG, Vital signs, Blood/urine tests, CT/MRI scans & ECHO recordings or MUGA scans and questionnaires.
Summary of Results
The summary of results contains graphics so we have been unable to provide this information as part of this submission. ClinicalTrials.gov has been updated with summary of results, and this information is accessible in the public domain. You can learn more about this study on these websites:
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If you want to find out more about the results of this study, the full title of the relevant scientific paper is: “A phase II randomized trial of cobimetinib plus chemotherapy, with or without atezolizumab, as first-line treatment for patients with locally advanced or metastatic triple-negative breast cancer (COLET): primary analysis”. The authors of the scientific paper are: Adam Brufsky, Soo-Bong Kim, Zanete Zvirbule, Alexandru Eniu, Jeroen Mebis, and others. The paper is published in the journal Annals of Oncology, volume number 32, pages 652-660.REC name
North East - York Research Ethics Committee
REC reference
14/NE/1249
Date of REC Opinion
8 Jan 2015
REC opinion
Further Information Favourable Opinion