Protocol Title

A Phase II Study of Sunitinib Malate Single Agent for the Treatment of Women with Advanced Breast Cancer

Description

Isolated recurrence of disease in the chest wall or regional lymph nodes (loco-regional recurrence) affects 10% to 35% of women with operable breast cancer after their primary treatment. Loco-regional recurrences are associated with an increased risk of distant disease and death. Sunitinib malate is an orally administered inhibitor of several other receptor tyrosine kinases (growth-factor proteins) involved in tumor cell growth and survival. Sunitinib has shown anti-tumor efficacy in a variety of rodent breast cancer models. Single- and multiple-dose clinical pharmacokinetic studies of Sunitinib have been performed. The drug has been FDA approved for the treatment of renal cell cancer and gastrointestinal stromal cancers.

Treatment on this study is Sunitinib taken by mouth every day without a rest period in 4-week cycles. The dose is to be taken once daily in the morning, without regard to meals. Treatment will continue until disease progression, unacceptable side effects, or a decision to stop treatment.

Objectives

To evaluate overall tumor response rate of single agent sunitinib given orally once daily.

To evaluate anti-tumor activity and the side effects of subjects treated with regimen.

To explore patient-reported outcomes of health-related quality of life.

Eligibility

Patient is a female at least 18 years of age who is able to swallow capsules.

Patient has a histological diagnosis of metastatic breast cancer and has disease that can be measured on their imaging studies (CT scan, MRI, bone scan).

Patients of childbearing potential must have a negative pregnancy test and agree to use an accepted method of non-hormonal contraception.

Patient does not have brain metastases.

Patient must have adequate organ function and meet other guidelines for eligibility as specified by the protocol.

Contact

For the current eligibility status of and additional information about this clinical study, please contact Breastlink Clinical Research Group at 1-562-981-6101.

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