IPATASERTIB & ATEZOLIZUMAB AS ADJUNCT THERAPY FOR BREAST CANCER STUDY
Research type
Research Study
Full title
A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY AND EFFICACY OF IPATASERTIB IN COMBINATION WITH ATEZOLIZUMAB AND PACLITAXEL OR NAB-PACLITAXEL IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC TRIPLE- NEGATIVE BREAST CANCER
IRAS ID
234268
Contact name
Peter Schmid
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2017-001957-15
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
This research study will involve focusing on 2 drugs called ipatasertib and atezolizumab in combination with other study drugs (paclitaxel & nab-paclitaxel)as a possible first-line treatment option in patients with a tumour that does not depend on HER2 and hormone (oestrogen and progesterone) receptors, also known as 'triple-negative breast cancer' (TNBC).
Patients with TNBC that has spread to the rest of the body have a particularly poor clinical outcome. The overall survival rate is approximately 16 months. There are no approved first-line regiments or targeted therapies for patients with TNBC.
The drug Ipatasertib targets a cancer causing signalling pathway in tumour cells called phosphoinositide 3-kinase/protein kinase B (PI3K/Akt), specifically protein kinase B (AKT). Once AKT is inhibited, the cancer cell is prevented from proliferating further and/or apoptosis (cell suicide) occurs.
The drug Atezolizumab consists of humanized large Y-shaped proteins that help boost part of the immune system that deals with anti-tumour activity. Atezolizumab shows anti-tumour activity in cell based/laboratory models and cancer patients. Overall Atezolizumab is known to be safe and well tolerated in patients.
All patients in this study will continue to be treated until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent. Approximately 10−15 sites in North America, Europe, and the Asian Pacific will enrol approximately 40−54 patients.
First the drugs will be tested for safety in patients, if all goes well then an expansion in the study will occur involving more patients to see if their TNBC responds to drug treatment. If the overall response in patients is meaningful, then the sponsor will open up a separate enrolment of patients where a biopsy will be mandatory to help understand how the drug is benefiting the patients at a molecular level.
REC name
London - Fulham Research Ethics Committee
REC reference
17/LO/1682
Date of REC Opinion
17 Nov 2017
REC opinion
Further Information Favourable Opinion