AZD9496 Vs Fulvestrant in Primary Breast Cancer
Research type
Research Study
Full title
A Open Label, Randomised, Pre-surgical, Pharmacodynamics Study to Compare the Biological Effects of AZD9496 versus Fulvestrant in Postmenopausal Women with estrogen receptor positive HER-2 negative Primary Breast Cancer
IRAS ID
172946
Contact name
Hannah Coulter
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2014-005103-24
Duration of Study in the UK
1 years, 9 months, 2 days
Research summary
Approximately 80% of post-menopausal women with breast cancer have estrogen receptor positive (ER+) disease. Endocrine (hormonal) therapies are considered a standard of care in treating the disease however there remains a need for novel therapies.
Before starting large clinical trials with novel drugs, ‘window of opportunity’ studies can help to understand the effect of the drug on the tumour with an acceptable level of intrusion into a woman’s standard care pathway. A sample of tumour is taken at baseline, and then a drug is given for a short period after which a second tumour sample is taken at surgery or by a separate biopsy. Changes in biomarkers can then be studied.
AZD9496 is an investigational oral therapy being developed for patients with ER+ breast cancer. It has not yet been approved for use by regulatory authorities and therefore this study is part of a research project. This study will assess the effects of AZD9496 given at increasing doses on biomarkers in breast cancer in comparison with fulvestrant, a drug which works in a similar way. This study will also assess the tolerability of AZD9496 compared with fulvestrant. Also DNA will be collected for exploratory research.
The study is planned in approximately 16 centres, 8 in the UK, 8 in Germany. Approximately 100 patients with newly diagnosed breast cancer scheduled for curative surgery will be recruited in 3 groups. The first two groups will include approximately 24 patients, randomised to either AZD9496 or fulvestrant. The final group will include approximately 48 patients, randomised in a 3:1 ratio to AZD9496 or fulvestrant. Additional groups may also be included.
Treatment with AZD9496 for 7-14 days or fulvestrant is followed by surgery or biopsy and then follow up for 28 days.
Data from this study will help select doses for future AZD9496 trials.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0453
Date of REC Opinion
27 Jan 2016
REC opinion
Further Information Favourable Opinion