Status:
TERMINATED
A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Barnes-Jewish Hospital
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effects of Plavix and aspirin in women with metastatic breast cancer.
Eligibility Criteria
Inclusion
- Women with metastatic breast cancer who are completing planned course of chemotherapy with planned treatment break
- On stable hormone therapy for at least 2 months are also eligible for the study
- Estimated survival of at least 3 months
- No platelet inhibitor therapy within 1 month of study entry
- Platelets ≥ 100,000
- Coagulation screening tests within normal range (INR between 0.81 and 1.20)
- Normal kidney and liver function as defined by:
- Aspartate aminotransferase(AST)/serum glutamic oxaloacetic transaminase (SGOT))/alanine aminotransferase(ALT) ≤ 2 x Institutional Normal
- Creatinine ≤ 2 x Institutional Normal
- Able to provide signed, informed consent.
Exclusion
- Patients going on to surgery
- Patients with a serious bleeding disorder that make them inappropriate candidates for NSAID therapy
- Patients with history of significant bleeding related to peptic ulcer disease
- Patients on standing doses of NSAIDS or platelet function inhibitors
- Patients on standing doses of anti-coagulants
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00263211
Start Date
January 1 2006
End Date
September 1 2009
Last Update
March 15 2017
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110