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

Stopped early · Phase 1/Phase 2

Conditions studied: Breast Neoplasms

In brief

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.

Key facts

Study ID

NCT00417885

Run by

Pfizer

People needed

6

Starts

2007-06-01

Expected to finish

2009-07-01

Last updated by the study team

2010-09-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)]

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Montreal, Quebec, Canada
• Pfizer Investigational Site — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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