Weekly Vinorelbine and Oral Capecitabine as Treatment for Stage IV Breast Cancer
Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
Summary
The primary purpose of the study is to examine the safety and effectiveness of combination
therapy consisting of daily oral capecitabine and weekly intravenous vinorelbine in stage IV
breast cancer subjects. The study is designed to assess the safety and effectiveness of this
combination therapy. Safety will be assessed by analyzing the types of toxicity, the severity
of toxicity and the need for dose modification or delay due to toxicity. Effectiveness will
be assessed by analyzing response rates, time to treatment failure, time to progression and
overall survival. Our hypothesis is that the regimen will be more effective than standard
historic regimens for this type and stage of cancer.