Conditions: Breast Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 219
Healthy volunteers: no

Brief summary:
To test the efficacy of CP-751,871 combined with exemestane in the treatment of postmenopausal patients with hormone positive advanced breast cancer

Detailed description:

Arms:
arm 1: CP-751,871 + exemestane Treatment until progression or toxicity arm 2: None

Interventions: intervention 1: CP-751,871 intervention 2: exemestane intervention 3: exemestane intervention 4: Fulvestrant
Intervention descriptions: intervention 1: CP-751,871 given at 20 mg/kg IV on day 1 of each 21 day cycle. intervention 2: Exemestane given at 25 mg orally once a day. intervention 3: Exemestane given at 25 mg orally once a day. Treatment until progression or toxicity intervention 4: Used for salvage therapy and administered according to the local label and standard clinical practice.

Protocol document: