Clinical Trials Directory

Trials / Completed

CompletedNCT00559507

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

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
12 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGsaracatinib
OTHERlaboratory biomarker analysisCorrelative studies

Timeline

Start date
2007-10-01
Primary completion
2011-02-01
Completion
2011-02-01
First posted
2007-11-16
Last updated
2014-04-30
Results posted
2014-01-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00559507. Inclusion in this directory is not an endorsement.