Stage IV Breast Cancer Clinical Trial
Official title:
A Phase II Study of AZD0530 in Hormone Receptor-Negative, Metastatic or Unresectable, Locally Advanced Breast Cancer
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
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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