A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients

• Status: Terminated
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to determine the effects of Plavix and aspirin in women with metastatic breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Washington University School of Medicine
• Collaborator: Barnes-Jewish Hospital
• Treatments: Aspirin; Clopidogrel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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