CO41012 IPATASERTIB with PALBOCICLIB and Fulvestrant
Research type
Research Study
Full title
A PHASE IB/III STUDY OF IPATASERTIB PLUS PALBOCICLIB AND FULVESTRANT VERSUS PLACEBO PLUS PALBOCICLIB AND FULVESTRANT IN HORMONE RECEPTOR POSITIVE AND HER2 NEGATIVE LOCALLY ADVANCED UNRESECTABLE OR METASTATIC BREAST CANCER
IRAS ID
266953
Contact name
Nicholas Turner
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Eudract number
2019-001072-11
Duration of Study in the UK
1 years, 8 months, 10 days
Research summary
Globally, breast cancer is the second most common invasive malignancy and the most common cause of cancer-related mortality in women.
Breast cancer accounts for approximately 7% of all cancer deaths. Hormone receptor positive (HR+) human epidermal growth factor receptor 2 negative (HER2-) breast cancer accounts for approximately 70% of all breast cancer subtypes.
Despite the benefits from approved therapies, HR+ metastatic breast cancer remains an incurable disease. Given the remaining unmet clinical need, this population is considered appropriate for trials of novel therapeutic candidates to identify therapies that could further enhance treatment regimens.
As a novel target along the validated PI3K/AKT/mTOR pathway, ipatasertib has shown promising clinical activity in multiple clinical trials. The clinical safety profile of Ipatasertib has been evaluated in multiple clinical trials, both as a single agent and in combination with paclitaxel. Ipatasertib is a potent, highly selective, small-molecule inhibitor of all three isoforms of the serine/threonine kinase AKT.
Palbociclib is a CDK4/6 inhibitor indicated for the treatment of HR+ HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women; or in combination with fulvestrant in women with disease progression following endocrine therapy.
Fulvestrant is a selective estrogen receptor down-regulator indicated for the treatment of postmenopausal women with advanced/metastatic breast cancer not previously treated with endocrine therapy, or with disease progression on antiestrogen therapy. Fulvestrant has been successfully combined with CDK4/6 inhibitors, such as palbociclib.
This study will evaluate the efficacy, safety and pharmacokinetics of ipatasertib in combination with palbociclib and fulvestrant compared with a control arm.
370 patients will be recruited globally with approximately 20 patients recruited at 10 UK sites. The study will last approximately 1.5 - 2 years from first patient screened to last patient last visit.
The study is sponsored by F. Hoffman La Roche
Research Summary; Version 1, dated 20June2019
REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/1065
Date of REC Opinion
14 Aug 2019
REC opinion
Further Information Favourable Opinion