Clinical Trial SWOG 1207
- SWOG 1207: Phase-III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer. e3 Breast Cancer Study - evaluating everolimus with endocrine therapy
- Principal Investigator
- Sarika Jain
- Status: Accepting New Patients
- Study Type: Therapeutic, Treatment
- Protocol No:.SWOG 1207
- The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without your cancer returning.
- The current standard treatment after chemotherapy is hormone treatment alone for early stage (stage 1-3) hormone receptor-positive breast cancer. Everolimus is a drug recently approved for the treatment of patients with advanced or metastatic (cancer that has spread to other parts of the body) hormone receptor-positive breast cancer in combination with hormone therapy. It is considered investigational for early stage breast cancer patients. Investigational or experimental means that the study drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA). In this study you will get hormone treatment with either everolimus or with placebo (a pill with no medication). Because the combination of hormone therapy and everolimus was effective in patients with advanced breast cancer, we are looking to see if this combination is effective in patients with early stage breast cancer.
Some of the eligibility criteria include:
- Participants must have breast cancer that is estrogen receptor positive (ER+) and/or progesterone receptor (PR+) and is HER-2 negative.
- Participants must be scheduled to receive adjuvant endocrine therapy.
- Participants must have completed either breast-conserving surgery or total mastectomy.
- Description of Treatment
- Participants in this study will be randomized to either hormone treatment plus placebo or hormone treatment plus everolimus. The hormone therapy given is one of the standard types of endocrine treatment (either tamoxifen, goserelin acetate, leuprolide acetate, or an aromatase inhibitor, or both- given over a period of 5-10 years). The decision on which of these to take will be made by the participants and their doctor. Everolimus/placebo is a pill that is taken daily, by mouth. Participants will be asked to take the study drug for 54 weeks, or until their side effects become too great, or until their cancer returns.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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Other Clinical Trials by Sarika Jain
- A Randomized Phase II Trial of Tamoxifen Versus Z-Endoxifen HCL in Postmenopausal Women with Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer
- A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Patients with Hormone Receptor-Positive Advanced Breast Cancer
- A Phase I Study of BYL719 and Trastuzumab-MCC-DM1 in HER2-Positive Metastatic Breast Cancer Patients with Progression on Prior Trastuzumab and Taxane-Based Therapy
last updated: 08-Feb-16 09:11 PM
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