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A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients
This study is ongoing, but not recruiting participants.

First Received on December 6, 2005.   Last Updated on August 4, 2011   History of Changes
Sponsor: Washington University School of Medicine
Collaborator: 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Impact Of Platelet Function Inhibition On Circulating Cancer Cells In Metastatic Breast Cancer Patients

Resource links provided by NLM:


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 ]

Enrollment: 48
Study Start Date: January 2006
Estimated Study Completion Date: August 2011
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.
Other Names:
  • Plavix=Clopidogrel Bisulfate
  • Aspirin=acetylsalicylic acid
No Intervention: 2
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

Locations
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
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

No publications provided

Responsible Party: Katherine Weilbaecher, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00263211     History of Changes
Other Study ID Numbers: 05-0427
Study First Received: December 6, 2005
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Aspirin
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists

ClinicalTrials.gov processed this record on February 09, 2012