Conditions: Breast Neoplasms
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: no

Brief summary:
To assess progression-free survival at the combination dose determined in the Phase 1 portion of the study, and safety of sunitinib combined with exemestane in patients with metastatic or locally-recurrent, unresectable breast cancer.

Detailed description:
The trial was terminated prematurely on August 28, 2008 due to the inability to recruit the planned number of subjects in order to provide meaningful efficacy data. There were no safety concerns regarding the study in the decision to terminate the trial.

Arms:
arm 1: sunitinib + exemestane

Interventions: intervention 1: exemestane intervention 2: sunitinib malate
Intervention descriptions: intervention 1: 25 mg, oral, daily dosing intervention 2: 37.5 mg, oral, continuous dosing, daily

Protocol document: