Metastatic Breast Cancer Clinical Trial
Official title:
A Pilot Study of Taxotere (Docetaxel) Combined With Xeloda (Capecitabine) in the Treatment of Metastatic Breast Cancer
The purpose of this study is to attempt to find better tolerated doses and schedules of this highly effective combination chemotherapy regimen.
Combination chemotherapy has advantages over monochemotherapy due to the higher response
rates that can often be obtained; by using agents with non-overlapping toxicity profiles,
these responses can be achieved with less toxicity than maximally tolerated doses of single
agents. One significant advantage of capecitabine/weekly docetaxel combination chemotherapy
is that both agents appear to have a toxicity profile appropriate for palliative therapy of
advanced breast cancer. This trial will utilize the usual schedule of capecitabine used in
the USA, which is two times per day oral dosing for 14 days but at a reduced dose in hopes
of decreasing toxicities. Docetaxel will be given weekly at a dose of 35 mg/m2 X 2 with a
one-week rest to coincide with the 14-day schedule of capecitabine.
The primary objective is to evaluate the overall response rate (complete and partial
responses) according to the RECIST criteria of the combination of capecitabine and docetaxel
with the selected schedule in patients with advanced and/or metastatic breast cancer. The
secondary objectives are to evaluate tolerability, time to tumor progression, and time to
treatment failure of the combination of capecitabine and docetaxel.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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