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Sponsors and Collaborators: |
Washington University School of Medicine Barnes-Jewish Hospital Foundation |
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Information provided by: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00263211 |
The purpose of this study is to determine the effects of Plavix and aspirin in women with metastatic breast cancer.
Condition | Intervention | Phase |
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Breast Neoplasms |
Drug: Plavix/Aspirin Other: No Intervention |
Phase II |
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 |
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 |
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1: Experimental
Plavix/Aspirin
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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.
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2: No Intervention
Observation by treating physician
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Normal kidney and liver function as defined by:
Exclusion Criteria:
Contact: Jenny Edrington | 314-362-0202 | edringtj@ccadmin.wustl.edu |
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 |
Principal Investigator: | Katherine Weilbaecher, M.D. | Washington University School of Medicine |
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 |
Breast Cancer Metastatic Platelet |
Aspirin Skin Diseases Clopidogrel Breast Neoplasms Breast Diseases |
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 |