A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients
NCT ID: NCT00263211
Last Updated: 2017-03-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
48 participants
INTERVENTIONAL
2006-01-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Plavix and Aspirin
Patients will receive a 300 mg loading dose of Plavix on day 1, followed by 75 mg/day, and aspirin 81 mg per day starting day 1. Treatment will be continued until the treating physician elects to resume systemic therapy for the treatment of breast cancer or until unacceptable toxicity is observed. A pill diary will be collected monthly to monitor patients' compliance with the medication regimen.
Plavix
Aspirin
Observation only
Observation by treating physician
No interventions assigned to this group
Interventions
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Plavix
Aspirin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
FEMALE
No
Sponsors
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Barnes-Jewish Hospital
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Katherine N Weilbaecher, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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05-0427 / 201107340
Identifier Type: -
Identifier Source: org_study_id
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