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

This study has been terminated.
(Stopped due to low percentage of patients with detectable CTCs at baseline.)
Sponsor:
Collaborator:
Barnes-Jewish Hospital
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00263211
First received: December 6, 2005
Last updated: January 24, 2017
Last verified: January 2017
Results First Received: July 21, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant;   Primary Purpose: Treatment
Condition: Breast Neoplasms
Interventions: Drug: Plavix
Drug: Aspirin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study opened for enrollment in January 6, 2006 and closed enrollment in May 25, 2010

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
Observation Only Observation by treating physician

Participant Flow:   Overall Study
    Plavix and Aspirin   Observation Only
STARTED   24   24 
COMPLETED   19   23 
NOT COMPLETED   5   1 
Death                1                0 
Withdrawal by Subject                3                0 
Protocol Violation                1                0 
Disease Progression                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Observation Only Observation by treating physician
Total Total of all reporting groups

Baseline Measures
   Plavix and Aspirin   Observation Only   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   24   48 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.7  (12.01)   58.4  (12.06)   55.79  (12.97) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      24 100.0%      24 100.0%      48 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   24   24   48 
The Number of Participants with Detectable Positive Circulating Tumor Cells (CTCs=>1) at Baseline [1] 
[Units: Participants]
 12   18   30 
[1] The number of participants with detectable CTCs (>= 1 CTC) was calculated at baseline.
Human Epidermal Growth Factor Receptor 2 Positivity (HER2+) [1] 
[Units: Participants]
 8   10   18 
[1] Some breast cancers have high amounts of a protein called HER2/neu on the surface of the cancer cells (called HER2/neu-positive (HER2-positive) breast cancer). The HER2/neu protein is important for cancer cell growth.
Estrogen Receptor Positivity (ER+) [1] 
[Units: Participants]
 15   13   28 
[1] Estrogen Receptor + means that the breast cancer is considered “hormone-receptor-positive.”
Number of Metastatic Sites 
[Units: Participants]
     
 8   9   17 
 7   7   14 
≥3   9   8   17 
Number of Previous Metastatic Chemotherapy Regimens 
[Units: Participants]
     
 6   4   10 
 5   8   13 
 4   6   10 
≥3   9   6   15 
Number of Previous Metastatic Endocrine Therapies 
[Units: Participants]
     
 8   11   19 
 7   3   10 
≥2   9   10   19 
Number of Participants Concurrently using Trastuzumab 
[Units: Participants]
 5   9   14 
Number of Participants Concurrently using Bisphosphonate 
[Units: Participants]
 12   9   21 
Number of Participants who Smoke 
[Units: Participants]
 4   5   9 


  Outcome Measures
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1.  Primary:   Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs   [ Time Frame: Week 4 ]

2.  Primary:   Safety and Tolerability of Aspirin and Plavix Measured by the Number of Patients Who Discontinue the Study Drug   [ Time Frame: Maximum of 6 months ]

3.  Secondary:   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 ]

4.  Secondary:   Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups   [ Time Frame: Baseline, 2 weeks and 1 month ]

5.  Secondary:   Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups   [ Time Frame: Baseline, 2 weeks and 1 month ]

6.  Secondary:   Progression Free Survival   [ Time Frame: Maximum of 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Inclusion of patients with no or few CTC's limited ability to distinguish anti-platelet therapeutic effect.

Early termination because of low probability of reaching statistical significance for primary outcome



  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Katherine Weilbacher, M.D,
Organization: Department of Medicine Div. of Oncology, Washington University School of Medicine St. Louis MO
phone: Fax: 314-454-8973
e-mail: kweiblac@dom.wustl.edu



Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00263211     History of Changes
Other Study ID Numbers: 05-0427 / 201107340
Study First Received: December 6, 2005
Results First Received: July 21, 2016
Last Updated: January 24, 2017