A Study of Herceptin (Trastuzumab)and Biomarkers in Patients With HER2-Positive Metastatic Breast Cancer
Status:
Completed
Trial end date:
2013-02-18
Target enrollment:
Participant gender:
Summary
This single arm study will evaluate alterations in molecular marker expression in
HER2-positive targeted therapy, and will evaluate the effect of continued treatment with
Herceptin and Xeloda beyond progression following initial Herceptin-taxane chemotherapy.
Patients who develop progressive disease will receive first-line Herceptin (8mg/kg iv loading
dose and 6mg/kg iv every 3 weeks) + taxane therapy. patients who develop progressive disease
within 9 weeks of treatment will continue treatment with Herceptin in combination with Xeloda
(1000mg/m2 po bid on days 1-14 of each 3-week cycle).Biopsies of tumor tissue will be taken
for biomarker and gene profiling evaluation. The anticipated time on study treatment is until
disease progression, intolerable side effects or patient choice, and the target sample size
is 100 individuals.