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

• Status: Terminated
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Exemestane; Sunitinib

Criteria

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]
• 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