Center for Global Research Data

Meta-analysis of the adverse effects of trastuzumab in women with breast cancer

Lead Investigator: Alexandra Freeman, University of Cambridge
Title of Proposal Research: Meta-analysis of the adverse effects of trastuzumab in women with breast cancer
Vivli Data Request: 5869
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

The benefits of drugs for women with breast cancer are very well quantified, and are used to help decide which treatments might be of benefit to a particular woman. However, in order to make an informed choice, patients also need a similar quantification of the potential adverse effects of each drug. Currently there is no systematic review and meta-analysis of the results of drug trials in the major treatments for women with breast cancer (such as trastuzumab).

We are carrying out a series of analyses of data from trials that have been carried out using the drug trastuzumab (also known as Herceptin), which is used in women with breast cancer, to identify how many women suffer side effects and of what kind and severity.

To do this we are carrying out a number of analyses, one of which aims to identify whether there might be different side-effects in different kinds of women (for example, those who are pre- menopausal as opposed to post-menopausal) or whether there might be interactions between different drug regimes that could affect the side effects that women suffer (eg. do those taking certain chemotherapy drugs alongside trastuzumab suffer different side effects from those not taking them?).

For these two kinds of analysis, we need data for individual patients – not identifiable data, but data that tells us characteristics of each patient and what other drugs they were taking, alongside the data about the side effects that they suffered.

Requested Studies:

A Randomized Three-Arm, Multicenter Comparison of 1 Year and 2 Years of Herceptin Versus No Herceptin in Women With HER2-Positive Primary Breast Cancer Who Have Completed Adjuvant Chemotherapy (HERA)
Sponsor: Roche
Study ID: NCT00045032
Sponsor ID: BO16348