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Clinical Trial DRUG CRAD001Y24135

Title
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
Principal Investigator
William Gradishar
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.DRUG CRAD001Y24135
Purpose
The purpose of this study is to find out if combining everolimus with letrozole is safe and has beneficial effects in postmenopausal women who have estrogen positive HER2 negative locally advanced or metastatic breast cancer. Additionally, this study aims to find out if everolimus plus exemestane is safe and has beneficial effects in women with estrogen positive locally advanced or metastatic breast cancer after treatment with everolimus plus letrozole. This study will also aim to find out if a mouth rinse can help reduce the severity of oral stomatitis, a common side effect of everolimus. This part of the study will be conducted where an alcohol free 0.5mg/5ml dexamethasone oral solution is commercially available.
Overview
Enrolled patients will receive everolimus in combination with letrozole in the first line setting until disease progression, unacceptable toxicity or withdrawal of consent. Following disease progression in the first line setting, patients will be offered everolimus in combination with exemestane. Patients who discontinue treatment in the first line setting due to unacceptable toxicity or due to withdrawal of consent will not be offered everolimus plus exemestane. Those patients treated in the second line setting will continue treatment until disease progression, unacceptable toxicity or withdrawal of consent.
Eligibility
Some of the eligibility criteria include:
  • Participants must be women who have estrogen receptor positive HER2 negative metastatic or locally advanced breast cancer (the cancer has spread beyond the breast).
  • Participants must be 18 or older.
  • Participants may not have had prior treatment for metastatic breast cancer.
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
Study participants will begin by taking everolimus and letrozole every day, by mouth. If the participant's disease progresses (or gets worse) while taking everolimus and letrozole she may be offered everolimus together with exemestane, taken every day, 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: 22-Jul-14 10:42 PM

 

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