CO40016 - A study of Ipatasertib with Paclitaxel in Breast Cancer
Research type
Research Study
Full title
A DOUBLE-BLIND, PLACEBO-CONTROLLED,RANDOMIZED PHASE III STUDY OF IPATASERTIB IN COMBINATION WITH PACLITAXEL AS A TREATMENT FOR PATIENTS WITH PIK3CA/AKT1/PTEN-ALTERED, LOCALLY ADVANCED OR METASTATIC, TRIPLE-NEGATIVE BREAST CANCER OR HORMONE RECEPTOR–POSITIVE, HER2-NEGATIVE BREAST CANCER
IRAS ID
232925
Contact name
Sarah Slater
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2017-001548-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 3 months, 13 days
Research summary
Ipatasertib is an experimental drug, which means health authorities have not approved it, alone or in combination with paclitaxel to treat breast cancer.
Paclitaxel is a chemotherapy drug that is already approved in some countries, including the UK for the treatment of breast cancer. Paclitaxel will be an investigational drug for this study.
Currently ipatasertib is being tested in patients with triple-negative breast cancer (hormone receptor-negative/HER2-negative breast cancer; known as TNBC) and hormone receptor-positive/HER2-negative breast cancer (known as HR+ /HER2- breast cancer) and other types of cancer.
Ipatasertib is designed to block a protein that is known to promote the growth of cancer cells. In animal studies and laboratory experiments ipatasertib has been shown to prevent or slow the growth of many different types of cancer cells, including breast cancer cells.
Paclitaxel is a type of chemotherapy that kills or stops the growth of cancer cells. Preliminary studies have shown that the combination of ipatasertib and chemotherapy (paclitaxel) were even more effective at slowing tumour growth than when given alone.
For this study patients with locally advanced or metastatic, triple-negative breast cancer or hormone receptor–positive, her2-negative breast cancer will be invited to take part. The study aims to compare the effects, good or bad, of ipatasertib in combination with paclitaxel versus placebo (a substance that looks like ipatasertib but does not contain any drug) plus paclitaxel to find out which works better.
The total length of the study, from screening of the first patient to the end of the study, is expected to be approximately 53 months.
A total of 450 participants will take part in this global study which is designed to evaluate the efficacy, safety, and the body’s use of ipatasertib given with chemotherapy (paclitaxel). It is anticipated that in the UK approximately 23 patients over 6 UK sites will be recruited.
The study is sponsored by F. Hoffman La Roche.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0375
Date of REC Opinion
19 Jan 2018
REC opinion
Further Information Favourable Opinion