Trail Assigning Individualized
Options for Treatment
| Time frame of study: | Ongoing |
| Location of Study: | Beth Israel Medical Center |
| Contact: | Continuum Cancer Research Program |
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 and Treatment Plan:
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.
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