Open-label, Phase II, Study of Everolimus Plus Letrozole in Postmenopausal Women With ER+, HER2- Metastatic or Locally Advanced Breast Cancer
Condition: Hormone Receptor Positive Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Everolimus; Letrozole; Exemestane; Alcohol-free dexamethasone mouth rinse (Stomatitis sub-study); Standard of care to treat stomatitis (Stomatitis sub-study)
Intervention description: Everolimus was self-administered as a daily dose of 10mg (two 5mg tablets) taken orally continuously until progression of disease, unacceptable toxicity or withdrawal of consent.; 1st line study treatment: Letrozole was self administered as a daily dose of 2.5mg continuously until disease progression or any other reason for which the patient might be discontinued; 2nd Line Study Treatment: Exemestane was self administered as a daily dose of 25mg taken orally continuously until disease progression or any other reason for which the patient might be discontinued; Alcohol-free 0.5mg/5ml dexamethasone oral solution was self-administered at a daily dose of 10ml 3 times per day (participants with confirmed stomatitis who entered the stomatitis sub-study).; Standard of care used to treat stomatitis at the patient's center (participants with confirmed stomatitis who entered the stomatitis sub-study).
Intervention MeSH terms: Dexamethasone; Everolimus; Letrozole; Exemestane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: The main study was an open-label single-arm study. The stomatitis sub-study was a randomized open-label study with two arms: dexamethasone and standard of care.
Masking: None (Open Label)
Enrollment: 202.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic breast cancer; Locally advanced breast cancer; HER2-; ER+; Everolimus; Afinitor

Summary:

      The purpose of this study was to assess the efficacy and safety of first-line treatment with
      everolimus plus letrozole in postmenopausal women with estrogen receptor-positive (ER+),
      human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic
      breast cancer.

      Moreover, the study also aimed to investigate the efficacy and safety of second line
      treatment with everolumus plus examestane in participants whose disease progressed during
      everolimus plus letrozole therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with metastatic or locally advanced, unresectable breast cancer not amenable
             to curative treatment by surgery or radiotherapy

          -  Histological or cytological confirmation of ER+/ 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 had received prior hormonal or any other systemic therapy for metastatic
             breast cancer. Patients might 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 might apply