Conditions: Breast Cancer
Keywords: Breast Cancer Estrogen Receptor positive ER+ exemestane mTOR everolimus refractory NSAI
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 724
Healthy volunteers: no

Brief summary:
There are no treatments specifically approved after recurrence or progression on a non steroidal aromatase inhibitors (NSAI). In light of the need for new treatment options for postmenopausal women after failure of prior NSAI therapy, the purpose of this Phase III study is to compare efficacy and safety of a treatment with exemestane + everolimus to exemestane + placebo in postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer refractory to NSAI.

Detailed description:

Arms:
arm 1: Everolimus 10 mg daily in combination with exemestane 25 mg daily arm 2: Placebo of everolimus in combination with exemestane 25 mg daily

Interventions: intervention 1: Everolimus intervention 2: Exemestane intervention 3: Everolimus Placebo
Intervention descriptions: intervention 1: Everolimus was formulated as tablets of 5-mg strength and was packaged into blister packs . Everolimus (two 5 mg tablets daily) were administered in a blinded manner on their respective treatment arms by continuous oral daily dosing. intervention 2: Exemestane 25 mg orally daily. intervention 3: Placebo was formulated to be indistinguishable from the everolimus tablets. Matching placebo (two tablets daily) were administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.

Protocol document: