Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) in Patients With Hormone Receptor-Positive Cancers With Recurrence Scores ≥ 25
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.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response to pre-operative docetaxel and Cytoxan (TC)
Patients will be assessed for surgery after 6 cycles of TC (18 weeks). The primary method of response determination will be by clinical examination, but mammography, breast ultrasound and breast MRI can be used to confirm response or non-response at the discretion of the investigator.
approximately 18 weeks
Yes
Amelia Zelnak, MD
Principal Investigator
Emory University Winship Cancer Institute
United States: Institutional Review Board
WCI1505-08
NCT00832338
April 2009
October 2014
Name | Location |
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Emory University Winship Cancer Institute | Atlanta, Georgia 30322 |