Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosed18 and overPharmaceutical / IndustryCRAD001Y24135
2012-003065-17, NCT01698918

Trial Description


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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Novartis Pharmaceuticals Corporation

    Novartis Pharmaceuticals, Study Director

    Link to the current record.
    NLM Identifier NCT01698918 processed this data on May 21, 2015

    Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to