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: Accepting New Patients
- 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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- A Phase 2, Randomized, Open-Label, Multicenter, Safety and Efficacy Study of Oral Lucitanib in Patients with FGF Aberrant Metastatic Breast Cancer
- An Open-Label, Phase II, Single-Arm Study of Everolimus in Combination with Letrozole in the Treatment of Postmenopausal Women with Estrogen Receptor Positive HER2 Negative Metastatic or Locally Advanced Breast Cancer
- A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or Veliparib in Combination with Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer That Is Estrogen or Progesterone Receptor-Positive and HER2-Normal
last updated: 24-Nov-14 11:45 AM
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