GO28888 Neoadjuvant Letrozole and GDC-0032 in ER+/HER2- Breast Cancer
Research type
Research Study
Full title
A PHASE II RANDOMIZED, DOUBLE-BLIND STUDY OF NEOADJUVANT LETROZOLE PLUS GDC-0032 VERSUS LETROZOLE PLUS PLACEBO IN POSTMENOPAUSAL WOMEN WITH ER POSITIVE/HER2-NEGATIVE, EARLY STAGE BREAST CANCER
IRAS ID
137300
Contact name
Andrew Wardley
Contact email
Sponsor organisation
Genentech, Inc.
Eudract number
2013-000568-28
Clinicaltrials.gov Identifier
GO28888/BIG-3-13/SOLTI 1205/ABCSG 38, Sponsor's / Partners' reference numbers
Research summary
Breast cancer is the most frequently diagnosed cancer worldwide and the leading cause of cancer death among females, accounting for 23% of the total cancer cases and 14% of total cancer deaths. As a large proportion of breast cancer cases in developed countries are now diagnosed in the early stages, they are amenable to cure with an appropriate combination of surgery, chemotherapy and/or hormonal therapy, and radiotherapy.
Estrogen receptor-positive (ER+) / human epidermal growth factor receptor 2-negative (HER2-) breast cancer accounts for the majority (about 60-70%) of all breast cancers. However, not all ER+ breast cancers respond optimally to endocrine therapy. There are several mechanisms that can lead to hormonal resistance in ER+ breast cancer and a cell pathway known as the PI3K/AKT/mTOR pathway plays an important role.
This study will test whether a new drug, GDC-0032, in combination with letrozole will improve the response to treatment in patients with early stage breast cancer given hormonal treatment prior to surgery. GDC-0032 inhibits a lipid kinase (PI3K) involved in tumour cell proliferation, survival and migration. Non-clinical studies demonstrate that GDC-0032 inhibits proliferation of breast cell lines and tumour growth. Available clinical data also include confirmed, partial responses in some patients treated with GDC-0032.
Post-menopausal women, with ER+ / HER2- early stage breast cancer may be eligible for inclusion in this study. The study is being conducted at specialist cancer centres in the UK (and internationally). Patients will be randomized to receive GDC-0032 or placebo, in combination with letrozole. During the study, patients will be seen frequently at clinic visits and will undergo tests (e.g. MRI scans, mammograms, breast ultrasound, core biopsies, blood tests, heart tests and questionnaires) to monitor the disease and safety of the study treatment. A pharmaceutical company, Genentech which is member of the Roche group, sponsors the study.
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REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
14/NW/1068
Date of REC Opinion
28 Jul 2014
REC opinion
Favourable Opinion