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

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ClinicalTrials.gov Identifier: NCT00263211
Recruitment Status : Terminated (Stopped due to low percentage of patients with detectable CTCs at baseline.)
First Posted : December 7, 2005
Results First Posted : March 15, 2017
Last Update Posted : March 15, 2017
Sponsor:
Collaborator:
Barnes-Jewish Hospital
Information provided by (Responsible Party):
Washington University School of Medicine

Tracking Information
First Submitted Date  ICMJE December 6, 2005
First Posted Date  ICMJE December 7, 2005
Results First Submitted Date  ICMJE July 21, 2016
Results First Posted Date  ICMJE March 15, 2017
Last Update Posted Date March 15, 2017
Study Start Date  ICMJE January 2006
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs [ Time Frame: Week 4 ]
    Measured by number of patients who have detectable circulating tumor cells
  • Safety and Tolerability of Aspirin and Plavix Measured by the Number of Patients Who Discontinue the Study Drug [ Time Frame: Maximum of 6 months ]
    Measured by number of patients who discontinue administration of study drug because of toxicity and the incidence categorized by type.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00263211 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2017)
  • Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time [ Time Frame: Baseline, 2 weeks and 1 month ]
    Percent of patients with a given number/range of CTCs ( 0, 1-5 >+ 5) vs. time baseline 2-weeks and 1 month for plavix & Aspirin arm and observation only
  • Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups [ Time Frame: Baseline, 2 weeks and 1 month ]
    Mean platelet inhibition vs. time plotted for Plavix & Aspirin Arm and Observation group. Citrated whole blood is added to a test carriage containing fibrinogen-coated beads and a platelet activator (arachidonic acid to synthesize thromboxane A2). Using a turbidimetric-based optical detection system, aggregation of activated platelets to fibrinogen-coated beads increase light transmittance which is reported in Aspirin Reaction Units (ARU).
  • Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups [ Time Frame: Baseline, 2 weeks and 1 month ]
    Mean Clopidogrel-Mediated platelet inhibition (% inhibition) vs. time for Aspirin and Plavix and Observation groups
  • Progression Free Survival [ Time Frame: Maximum of 6 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients
Official Title  ICMJE The Impact Of Platelet Function Inhibition On Circulating Cancer Cells In Metastatic Breast Cancer Patients
Brief Summary The purpose of this study is to determine the effects of Plavix and aspirin in women with metastatic breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: Plavix
    Other Name: Clopidogrel Bisulfate
  • Drug: Aspirin
    Other Name: acetylsalicylic acid
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Drug: Plavix
    • Drug: Aspirin
  • No Intervention: Observation only
    Observation by treating physician
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 2, 2010)
48
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00263211
Other Study ID Numbers  ICMJE 05-0427 / 201107340
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Barnes-Jewish Hospital
Investigators  ICMJE
Principal Investigator: Katherine N Weilbaecher, M.D. Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP