Clinical Trial SWOG 1007
- 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
- William Gradishar
- Status: CLOSED
- Study Type: Therapeutic, Treatment
- Protocol No:.SWOG 1007
- 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.
- 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.
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.
- 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.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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Other Clinical Trials by William Gradishar
- A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients with HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment
- A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer
last updated: 09-Dec-16 01:43 AM
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