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

Arms (1)

1. type

   EXPERIMENTAL

   label

   Everolimus+letrozole/exemestane (first line and second line treatment)

   description

   Participants received everolimus in combination with letrozole as first-line treatment. Only participants who had disease progression in the first line setting (core phase) were offered second-line treatment (everolimus in combination with exemestane)

   interventionNames

   1. Drug: Everolimus
   2. Drug: Letrozole
   3. Drug: Exemestane
   4. Drug: Alcohol-free dexamethasone mouth rinse (Stomatitis sub-study)
   5. Drug: Standard of care to treat stomatitis (Stomatitis sub-study)

Primary outcomes (1)

1. measure

   First-line Treatment: Progression-free Survival (PFS)

   timeFrame

   From the date of enrollment to the date of first documented progression or deaths, assessed up to approximately 2.8 years

   description

   PFS in the first line setting is defined as the time from the date of enrollment to the date of first documented progression based on local radiology review or death due to any cause. If a participant did not progress or was not known to have died at the date of the analysis cut-off or start of another antineoplastic therapy, the PFS date was censored to the date of last adequate tumor assessment prior to cut-off date or start of antineoplastic therapy. The median PFS was estimated and presented along with 95% confidence intervals. The primary analysis of PFS for first line was performed 12 months after the last patient's recruitment.