Invasive Breast Cancer Clinical Trial
Official title:
Phase II Trial of Primary Systemic Therapy for Locally Advanced Breast Cancer Using Sequential Doxil, Paclitaxel, and Cyclophosphamide With Concurrent Avastin
This study will evaluate the rate of response to the sequential therapy of Doxil,
paclitaxel, and cyclophosphamide with concurrent Avastin for patients with locally advanced
invasive (T2,T3, Nany, M0) breast carcinoma. Also, the study will evaluate the clinical and
subclinical cardiotoxic effect(s) of this regimen, assess how feasible and safe the study
is. Survival without any progression of disease will also be calculated.
A regimen of chemotherapy will be given to replicate the high rate of response in patients
with locally advanced breast cancer. Doxil will substitute the normally given doxorubicin.
It is expected that the low effect or minimal effect of Doxil on cardiac function will
minimize any additional risk of cardiotoxicity from Avastin. It is expected that clinical
and subclinical rates of cardiotoxicity will be very low at the total doses to be given in
this clinical trial.
In this trial, an attempt will be made to replicate the high rate of complete pathological
response in patients with locally advanced breast cancer with a regimen in which Doxil is
substituted for conventional doxorubicin. We expect that the low or minimal effect on
cardiac function produced by Doxil will minimize any additional risk of cardiotoxicity from
Avastin. We will also measure left ventricular ejection fractions before and after treatment
to see if the substantial rate of subclinical cardiotoxicity reported by Swain et al5 and
Perez et al7 can be avoided. The reported rates of cardiotoxicity after treatment with
relatively high doses of Doxil are substantially lower than those of doxorubicin; few data
are available to estimate the rate of cardiotoxicity of Doxil in patients treated with only
about 100 mg/m2 total accumulated dose, the dose to be utilized here. The drug has been used
in a few patients in the primary systemic therapy setting, with no reported clinical
cardiotoxicity.
The expectation is that clinical and subclinical rates of cardiotoxicity will be very low or
negligible at the total doses to be used here.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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