Spots Global Cancer Trial Database for Saracatinib in Treating Patients With Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed By Surgery

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Trial Identification

Brief Title: Saracatinib in Treating Patients With Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed By Surgery

Official Title: A Phase II Study of AZD0530 in Hormone Receptor-Negative, Metastatic or Unresectable, Locally Advanced Breast Cancer

Study ID: NCT00559507

Conditions

Estrogen Receptor-negative Breast Cancer

Male Breast Cancer

Progesterone Receptor-negative Breast Cancer

Recurrent Breast Cancer

Stage IIIB Breast Cancer

Stage IIIC Breast Cancer

Stage IV Breast Cancer

Interventions

saracatinib

laboratory biomarker analysis

Study Description

Brief Summary: This phase II trial is studying saracatinib to see how well it works in treating patients with metastatic or locally advanced breast cancer that cannot be removed by surgery. Saracatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth

Detailed Description: PRIMARY OBJECTIVES: I. To estimate the disease control rate of AZD0530 (saracatinib) in patients with metastatic breast cancer. SECONDARY OBJECTIVES: I. To estimate the efficacy of AZD0530 in terms of overall response rate (complete and partial response) and progression free survival. II. To describe the toxicity profile of AZD0530 in this patient population. III. To prospectively explore changes in circulating tumor cells from pre-treatment levels in patients receiving AZD0530. OUTLINE: Patients receive saracatinib orally (PO) on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 4 weeks.