Cyclophosphamide and Docetaxel Every 3 Weeks as Neoadjuvant Therapy in Locally Advanced Breast Cancer



Status:Archived
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:October 2010
End Date:October 2013

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Cyclophosphamide and Docetaxel Every 3 Weeks as Neoadjuvant Therapy in Locally Advanced Breast Cancer, A Collaborative Trial


The standard therapy for patients who have locally advanced breast cancer is to receive
chemotherapy before surgical removal of tumor. This is called neoadjuvant chemotherapy
(NAC). Chemotherapy is used to shrink the tumor before surgery, which sometimes may allow
for a smaller portion of the breast to be removed. Receiving chemotherapy before surgery
may sometimes also allow for smaller portions of the breast to be removed. Getting
chemotherapy prior to surgery may also control any hidden metastatic disease and thereby
decrease the risk of cancer relapse. Pre-surgery chemotherapy is a standard management
approach for locally advanced breast cancer.

Different combinations of drugs can be used as part of the pre-surgery chemotherapy. The
purpose of this study is to determine if using a chemotherapy regimen of TC is effective way
to manage locally advanced breast cancer (Stage IIA- IIIB) when the TC is given before
surgery. The investigators also hope this study will help us to better understand how the
tumor tissue is affected by this combination of chemotherapy drugs.

The TC drug combination is FDA approved for use in treating breast cancer, and it has been
shown to be equally effective as other commonly used chemotherapy regimens when used after
surgery; but, the TC drug combination has not yet been studied in conjunction with NAC for
use before surgery. The investigators will be studying the combination of TC used before
surgery as a means of possibly shrinking the tumor.


This is a single-arm, open-label phase II study of cyclophosphamide and docetaxel/taxotere
(TC) every 3 weeks in Her2 (-) subjects with locally advanced breast cancer. It is designed
to assess (1) the clinical and pathologic response rates to this regimen, as well as its
tolerability in this subject population, and (2) the expression of Tiam1 in tumor-associated
fibroblasts pre and post treatment.


We found this trial at
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Boston, Massachusetts 02111
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Boston, MA
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