Clinical Trial DRUG CRAD001Y24135
- 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
- Status: COMPLETED
- Study Type: Therapeutic, Treatment
- Protocol No:.DRUG CRAD001Y24135
- 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.
- 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.
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.
- 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.
- Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
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last updated: 11-Feb-16 06:57 AM
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