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Clinical Trial SWOG 1007

Title
A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes,Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less
Principal Investigator
Virginia Kaklamani
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.SWOG 1007
Purpose
The purpose of this study is to find out if the Oncotype DX Recurrence Score can help decide whether patients should receive chemotherapy or not.
Overview
Participants in this study are women with hormone-responsive breast cancer with 1-3 positive lymph nodes and have a Recurrence Score of 25 or less. This study uses the Oncotype Dx Recurrence Score, which is a test that looks at multiple genes related to breast cancer. The combination of the test results produces a score that is useful in guiding treatment choices for patients with node-negative breast cancer. The higher the score is, the more likely that the patient’s breast cancer will come back after surgery. Currently most women who have this kind of breast are treated with endocrine therapy (treatment that works with hormones). Many women also receive chemotherapy. Some women may be getting chemotherapy who do not need it. These women may be exposed to side effects of their treatment that are not a necessary risk in relation to the benefit they receive.
Eligibility
Some of the eligibility criteria include:
  • Participant must be a female at least 18 years of age.
  • Participants must be diagnosed with breast cancer that is not inflammatory or metastatic.
  • Participants must not have begun chemotherapy or endocrine therapy for breast cancer prior to registration.
  • Participants must have breast cancer that is estrogen and/or progesterone receptor positive and HER-2 negative.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
Participants in group one will receive chemotherapy through the vein (IV) and also one of the standard types of endocrine therapy, which is a pill taken by mouth. Participants in group two will get one of the standard types of endocrine therapy alone and this pill is taken by mouth.
Contact
Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 30-Aug-14 09:14 PM

 

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