To evaluate biomarkers in HER2 positive MBC with trastuzumab use
Research type
Research Study
Full title
A prospective Phase II study to evaluate alterations in molecular biomarkers in HER2-positive metastatic breast cancer together with assessment of trastuzumab use beyond progression after initial exposure to trastuzumab-taxane based treatment
IRAS ID
32499
Contact name
Stephen Chan
Sponsor organisation
Roche Products Limited
Eudract number
2008-004013-94
Clinicaltrials.gov Identifier
Research summary
Despite efforts at early diagnosis, and improvements in the treatment of early breast cancer, a significant percentage of women relapse and develop breast cancer that has spread to other parts of the body [metastases]. Additionally, women with HER2 positive breast cancer have a large amount of a protein called HER2 and have a relatively poor outlook.This study will consist of two different combinations of HER2 targeted therapy and a chemotherapy in patients with metastatic breast cancer (MBC). These are trastuzumab plus a taxane (either paclitaxel or docetaxel) and then if a patient??s cancer continues to grow/spread, their chemotherapy will be changed and the patient will receive trastuzumab and capecitabine. The aim of this study is to explore and potentially define changes in cancer cell biomarkers during HER2 targeted treatment and predict whether the cancer is either increasing or decreasing in sensitivity to treatment with trastuzumab. In order to explore these changes, patients will be asked to undergo biopsies of their metastases (removal of small tissue samples) and scans so that the doctor can assess these biomarkers on the cancer cells in relation to the growth or shrinkage of the patient??s cancer. There are a minimum of 3 and a maximum of 5 biopsies during the whole study.The possible benefit of this study could be a decrease in growth of the breast cancer and improvements in the symptoms of the breast cancer. Participation may help others by providing information about predicting which patients will respond well to the combination of a taxane chemotherapy and trastuzumab; and which patients will not.This research study is taking place in UK, Sweden and Australia. Approximately 50 adult female patients with HER2 positive MBC will be enrolled, with 12 patients expected across UK study centres.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
09/H0408/109
Date of REC Opinion
10 Dec 2009
REC opinion
Favourable Opinion