A Clinical Trial Assessing Efficacy and Safety of Sunitinib and Exemestane in Patients With ER [Estrogen Receptor] + and/or PgR [Progesterone Receptor] + Breast Cancer

Phase 1/2 Open-Label Trial Of Sutent (Sunitinib Malate) And Aromasin(Exemestane) In The First-Line Treatment Of Hormone Receptor-Positive Metastatic Breast Cancer

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.

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.

Inclusion Criteria:

• At least 18 years of age
• Estrogen and/or progesterone receptor positive adenocarcinoma of the breast with evidence of 1) unresectable 2)locally recurrent, or 3) metastatic disease
• Postmenopausal
• ECOG [Eastern Cooperative Oncology Group] </=1
• Evaluable(e.g bone only disease allowed) and Measurable disease [RECIST (Response Evaluation Criterion in Solid Tumors)]

Exclusion Criteria:

• HER2 [Human Epidermal Growth factor Receptor 2] positive disease not previously treated with herceptin
• Any prior anti-angiogenic therapy, endocrine or cytotoxic anti-cancer therapy in the metastatic disease setting
• Radiation therapy within 2 weeks of first study treatment