Neoadjuvant Doxorubicin, Polyglutamate Paclitaxel, Capecitabine and Metronomic Chemotherapy in Breast Cancer
Status:
Withdrawn
Trial end date:
2011-02-01
Target enrollment:
Participant gender:
Summary
The investigators propose to conduct a clinical trial of neoadjuvant treatment utilizing
chemotherapy formulations with favorable toxicity profiles: weekly doxorubicin, PPX and
capecitabine. It is expected this combination will at least maintain the efficacy of a
traditional chemotherapy regimen but will be associated with less toxicity, particularly
nausea, vomiting and alopecia. In order to accomplish this the investigators have designed a
chemotherapy regimen whose components (or administration schedule) are associated with
minimal or no alopecia and are also considered to have low emetogenic potential.
In an attempt to improve the efficacy of the regimen the investigators plan to study an
alternate schedule of cyclophosphamide and methotrexate administration (metronomic
chemotherapy) which appears to inhibit angiogenesis and therefore enhance the activity of
conventional cytotoxic chemotherapy administered concurrently.
In this trial the investigators aim to determine the clinical and pathologic response rate of
12 weeks of doxorubicin followed by 4 cycles of PPX and capecitabine. Metronomic chemotherapy
with cyclophosphamide and methotrexate will be administered during the 24 weeks of
chemotherapy.