Fulvestrant with GDC-0941/ GDC-0980 in Metastatic Breast cancer
Research type
Research Study
Full title
A phase II double-blind placebo-controlled randomized study of GDC-0941 or GDC-0980 with Fulvestrant versus Fulvestrant in advanced or metastatic breast cancer in patients resistant to aromatase inhibitor therapy
IRAS ID
79228
Contact name
Alison Jones
Sponsor organisation
Genentech, Inc.
Eudract number
2010-023763-17
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
The purpose of this study is to find out what effects, good and/or bad, two study drugs called GDC-0941 and GDC-0980 have on patients with metastatic breast cancer when given in combination with another drug, called fulvestrant. The target population for this study have a specific type of breast cancer which is positive for the estrogen receptor (ER) and negative for the human epidermal growth factor receptor 2 (HER2), and has worsened while receiving treatment with an aromatase inhibitor (another type of cancer treatment).GDC-0941 and GDC-0980 are study drugs that inhibit a protein called PI3 kinase that may be involved in the growth and spread of some cancers. In animal studies and laboratory experiments, GDC-0941 and GDC-0980 have been shown to prevent or slow the growth of many different types of human cancer cells. Both study drugs are currently being tested in clinical studies in people with advanced cancer.Fulvestrant is approved by Health Authorities in many countries, including the MHRA for the treatment of this type of breast cancer.The use of GDC-0941 and GDC-0980 in this research study alone or in combination with fulvestrant is experimental, which means that these study drugs are not approved by any regulatory agency for the treatment of breast cancer or for any other disease.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
11/EM/0321
Date of REC Opinion
11 Oct 2011
REC opinion
Further Information Favourable Opinion