Breast Cancer Clinical Trial
Official title:
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. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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