Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer
Basic Trial Information
|Phase II||Treatment||Active||18 and over||CRAD001Y24135|
NCI-2012-02282, 2012-003065-17, NCT01698918
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.
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
No prior treatment for metastatic breast cancer
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
Trial Contact Information
Trial Lead Organizations / Sponsors / Collaborators
Novartis Pharmaceuticals Corporation
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01698918
Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the ClinicalTrials.gov record via the link above for more information about participating sites.