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Program for the Assessment of Clinical Cancer Tests (PACCT-1):
Trial Assigning IndividuaLized Options for Treatment:

Time frame of study:		Ongoing
Location of Study:		Beth Israel Medical Center
Contact:		Continuum Cancer Center Research Program (212) 844-6286

Summary:
The following study uses the Oncotype Dx system to examine a patient’s tumor cell genetics. Oncotype Dx assesses the expression profile of 21 different genes in a given patient’s tumor and assigns a recurrence score to each patient. The recurrence score quantifies the patient’s risk of developing metastatic disease at 10 years after diagnosis. Currently, tumor size and age are the major factors in assigning chemotherapy treatment. Using information from Oncotype Dx, this study will evaluate the best treatment plan for patients based upon the genetics of their particular tumor. Subjects will be divided into three different groups based on their recurrence score, and those in the middle group will be randomly assigned to either hormonal therapy alone, or hormonal therapy plus chemotherapy. Data from this approach will allow physicians to “tailor” therapy regimens to individual patients in the future, separating the patients who need chemotherapy from those who do not.

Eligibility:
Patients with the following clinical criteria are eligible for this study. Non-pregnant women with early stage, ER or PR positive, axillary lymph node negative Breast Cancer who meet criteria for adjuvant chemotherapy. Please call for more information.

Benefits and/or Compensation:
There is no monetary compensation for participation on this study; however, information from this study may help doctors learn more about how to better select patients for treatment with chemotherapy.