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A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients
This study is currently recruiting participants.
Verified by Washington University School of Medicine, July 2008
Sponsors and Collaborators: Washington University School of Medicine
Barnes-Jewish Hospital Foundation
Information provided by: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00263211
  Purpose

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


Condition Intervention Phase
Breast Neoplasms
Drug: Plavix/Aspirin
Other: No Intervention
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Historical Control, Parallel Assignment, Efficacy Study
Official Title: The Impact Of Platelet Function Inhibition On Circulating Cancer Cells In Metastatic Breast Cancer Patients

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • The primary endpoint of efficacy is the proportion of the patients who have detectable circulating tumor cells (CTC) after completion of study (at the time of either resuming systemic treatment of breast cancer or unacceptable toxicity being observed). [ Time Frame: Approximately 3 years. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 76
Study Start Date: January 2006
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Plavix/Aspirin
Drug: Plavix/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.
2: No Intervention
Observation by treating physician
Other: No Intervention
Patients randomized to the no treatment arm will receive no anti-platelet drugs but will be monitored by the treating physician. Assessment of performance status, quality of life, CTC and platelet function will be performed. Patients will continue on the study until the treating physician elects to resume systemic therapy for the treatment of breast cancer, or until unacceptable toxicity is observed. Patients will be followed for 6 months maximum as part of the protocol.

Detailed Description:

All patients will have medical history, physical exam, and standard labs at baseline, including platelets, AST/ALT, creatinine, PT/PTT. Platelet function, CTC tests, and Urine Ntx will be taken at baseline, two weeks, and then monthly. Patients may remain on study until treating physician elects to resume systemic therapy. If patients continue on study after one month, they will receive physical exam, medical history/progress notes, standard labs, platelet function (at the treating physician's discretion), and CTC tests on a monthly (q 4 week) schedule or every 3 weeks if receiving trastuzumab or other i.v. medication that necessitates returning to the clinic on an every 3 week schedule.

Plavix/Aspirin Arm

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.

No Treatment Arm

Patients randomized to the no treatment arm will receive no anti-platelet drugs but will be monitored by the treating physician. Assessment of performance status, quality of life, CTC, and platelet function will be performed. Patients will continue on the study until the treating physician elects to resume systemic therapy for the treatment of breast cancer, or until unacceptable toxicity is observed. Patients will be followed for 6 months maximum as part of the protocol.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with metastatic breast cancer
  • Completing planned course of therapy with planned treatment break
  • Measurable or evaluable disease
  • Estimated survival of at least 3 months
  • Planned to be off therapy at least 1 month
  • No platelet inhibitor therapy within 1 month of study entry
  • Platelets > 100,000
  • Coagulation screening tests within normal range—INR between 1.0 and 1.4
  • Normal kidney and liver function as defined by:

    • AST/ALT < 2 x Institutional Normal
    • Creatinine < 2 x Institutional Normal

Exclusion Criteria:

  • Patients going on to endocrine therapy
  • Patients going on to surgery
  • Patients with a serious bleeding disorder that contraindicate the use of platelet function inhibitors
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263211

Contacts
Contact: Jenny Edrington 314-362-0202 edringtj@ccadmin.wustl.edu

Locations
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Beth Grigsby, M.A., CCRP     314-747-4112     grigsbya@ccadmin.wustl.edu    
Sponsors and Collaborators
Washington University School of Medicine
Barnes-Jewish Hospital Foundation
Investigators
Principal Investigator: Katherine Weilbaecher, M.D. Washington University School of Medicine
  More Information

Responsible Party: Washington University School of Medicine ( Katherine Weilbaecher, MD )
Study ID Numbers: 05-0427
Study First Received: December 6, 2005
Last Updated: October 27, 2008
ClinicalTrials.gov Identifier: NCT00263211  
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Breast Cancer
Metastatic
Platelet

Study placed in the following topic categories:
Aspirin
Skin Diseases
Clopidogrel
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions
Fibrin Modulating Agents
Neoplasms
Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009