Category: Cancer (Oncology), HIC#12657
Title:
Program for the assessment of clinical cancer tests (PACCT-1): Trial assigning individualized options for treatment: The TAILORx Trial
Contact:Elaine Dube
Phone:(434)924-9199
E-mail:ed7y@Virginia.EDU

UVa Health System, Cancer Center seeks women who have been diagnosed with early stage (I or II) breast cancer for a research study. You might be able to participate if you are a candidate for standard chemotherapy and you are not pregnant and your tumor is:
" HER2 receptor negative
" Estrogen Receptor and/or Progesterone Receptor positive
" has no positive lymph nodes

The purpose of TAILORx is to determine whether hormonal therapy alone is adequate treatment for those who have a tumor with a mid-range Recurrence Score (RS) of 11 to 25. In the TAILORx trial all participants will be assigned to a study group based on their RS on Genomic Health's Oncotype DX Assay. The Assay determines each participants RS by running tests on a sample of your tumor after it has been removed during surgery.

If you qualify and consent to participate in this study, you will be pre-registered and a sample of your tumor will be submitted to Genomic Health for testing with the Oncotype DX Assay. After your doctor receives the results of the test you will proceed to the registration stage and specific treatments based on your RS will be recommended.
" If your RS is 10 or less you will receive hormonal therapy, but no chemotherapy
" If your RS is 26 or more you will receive chemotherapy plus hormonal therapy
" If your RS is 11-25 you will be randomly assigned (by chance, like a coin flip) to treatment with either:
- hormonal therapy alone
- chemotherapy plus hormonal therapy

Contact Information:
For more information please contact:
" Elaine Dube (434)924-9199 or ed7y@virginia.edu
" IRB-HSR #12657

Principal Investigator: Anneke Schroen, MD
Primary Investigator: Brenin Christiana,
Department: Internal Medicine
 Accepts adult enrollment :NO
Accepts minor enrollment :NO