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

PhaseTypeStatusAgeTrial IDs
Phase IITreatmentActive18 and overCRAD001Y24135
NCI-2012-02282, 2012-003065-17, NCT01698918

Trial Description

Summary

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 / 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.