Breast Cancer Clinical Trial
Official title:
A Phase II Study Of The Weekly Administration Of Docetaxel In Combination With The Epidermal Growth Factor Receptor Inhibitor OSI-774 In Recurrent And/Or Metastatic Breast Cancer
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary
for tumor cell growth. Drugs used in chemotherapy use different ways to stop tumor cells
from dividing so they stop growing or die. Combining erlotinib with docetaxel may kill more
tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining erlotinib with docetaxel in
treating patients who have stage IV or recurrent breast cancer.
OBJECTIVES:
- Determine the antitumor effects of erlotinib and docetaxel, in terms of objective
response, stabilization of disease, and progression-free survival, in patients with
stage IV or recurrent breast cancer.
- Determine time to tumor progression in patients treated with this regimen.
- Compare time to tumor progression in patients who achieve disease stabilization or
response after treatment with this regimen and continue to receive erlotinib versus
patients who do not receive additional erlotinib.
OUTLINE: Patients receive docetaxel IV over 1 hour once weekly for 3 weeks and oral
erlotinib once daily beginning on day 1. Treatment repeats every 4 weeks for a minimum of 6
courses in the absence of unacceptable toxicity or disease progression. Patients achieving
maximal tumor response or stabilization of disease after 6 courses may continue to receive
erlotinib alone until disease progression.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 12-14
months.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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