Trial Using Docetaxel Cytoxan in Breast Cancers With High Recurrence Scores
Summary
The purpose of this study is to assess if docetaxel and cytoxan can shrink the size of your breast tumor and allow you to preserve your breast or have less extensive surgery on your breast. Additionally, by receiving chemotherapy before surgery, the investigators will be able to determine if your cancer is responsive to chemotherapy.
Description
Previous studies have shown that chemotherapy has the same effect on treating breast cancer whether you receive it before or after surgery. Receiving chemotherapy before surgery, rather than after surgery, may allow you to have less extensive surgery by shrinking the size of your cancer. The purpose of this study is to assess if docetaxel and cytoxan can shrink the size of your breast tumor and allow you to preserve your breast or have less extensive surgery on your breast. Additionally, by receiving chemotherapy before surgery, we will be able to determine if your cancer is responsive to chemotherapy. Prior to entering this study, a special test, called the Oncotype DX assay, will be performed on a small amount of your cancer from the biopsy you had at the time you were diagnosed with breast cancer, to determine the likelihood that your cancer will benefit from and shrink with chemotherapy. You will only be eligible to enter this study if the recurrence score determined using the Oncotype DX assay is 25 or greater. Patients with hormone receptor-positive breast cancers with recurrence scores greater than or equal to 25 have been previously demonstrated to obtain a significant benefit from chemotherapy given after surgery.
In addition, researchers would like to examine proteins present in your blood and proteins present in your breast tissue. These additional parts of the study are voluntary and are NOT required to participate in this study. This consent form will describe these parts of the study later, in Addendums I and II.
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Breast Neoplasms
Intervention
Docetaxel and Cytoxan
Location
Emory University Winship Cancer Institute
Atlanta
Georgia
United States
30322
Status
Recruiting
Source
Emory University
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00832338
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Breast Neoplasms, Male
Any neoplasms of the male breast. These occur infrequently in males in developed countries, the incidence being about 1% of that in females.
Neoplasms, Ductal, Lobular, And Medullary
Neoplasms, usually carcinoma, located within the center of an organ or within small lobes, and in the case of the breast, intraductally. The emphasis of the name is on the location of the neoplastic tissue rather than on its histological type. Most cancers of this type are located in the breast.
Inflammatory Breast Neoplasms
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
Breast Neoplasms
Tumors or cancer of the human BREAST.
Ultrasonography, Mammary
Use of ultrasound for imaging the breast. The most frequent application is the diagnosis of neoplasms of the female breast.
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