Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/13/2018 |
| Start Date: | March 7, 2013 |
| End Date: | June 4, 2020 |
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
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 only
in countries where an alcohol free 0.5mg/5ml dexamethasone oral solution is commercially
available.
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 only
in countries where an alcohol free 0.5mg/5ml dexamethasone oral solution is commercially
available.
Inclusion Criteria:
- Patients 18 years old or greater
- Patients with metastatic or locally advanced, unresectable breast cancer not amenable
to curative treatment by surgery or radiotherapy
- Histological or cytological confirmation of estrogen-receptor positive (ER+) human
epidermal growth factor receptor 2 negative (HER2-) breast cancer
- Postmenopausal women
- No prior treatment for metastatic breast cancer
Exclusion Criteria:
- Patients with only non-measurable lesions other than bone metastases (e.g., pleural
effusion, ascites, etc)
- Patients who have received prior hormonal or any other systemic therapy for metastatic
breast cancer.
- Patients may have received prior neoadjuvant or adjuvant endocrine therapy. In the
case of neoadjuvant or adjuvant NSAI (letrozole/anastrozole) therapy patients must
have completed therapy at least 1 year prior to study enrollment.
- Previous treatment with mTOR inhibitors.
- Known hypersensitivity to mTOR inhibitors, e.g., sirolimus (rapamycin).
- Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
19
sites
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Cone Health Cancer Center Located adjacent to Wesley Long Hospital, our Cone Health Cancer Center...
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