Back to resultsA Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients
Primary Purpose
Breast Neoplasms
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Plavix
Aspirin
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring Breast Cancer, Metastatic, Platelet
Eligibility Criteria
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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Plavix and Aspirin
Observation only
Arm Description
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 by treating physician
Outcomes
Primary Outcome Measures
Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs
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
Measured by number of patients who discontinue administration of study drug because of toxicity and the incidence categorized by type.
Secondary Outcome Measures
Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time
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
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
Mean Clopidogrel-Mediated platelet inhibition (% inhibition) vs. time for Aspirin and Plavix and Observation groups
Progression Free Survival
Full Information
NCT ID
NCT00263211
First Posted
December 6, 2005
Last Updated
January 24, 2017
Sponsor
Washington University School of Medicine
Collaborators
Barnes-Jewish Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00263211
Brief Title
A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients
Official Title
The Impact Of Platelet Function Inhibition On Circulating Cancer Cells In Metastatic Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Stopped due to low percentage of patients with detectable CTCs at baseline.
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Barnes-Jewish Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the effects of Plavix and aspirin in women with metastatic breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Breast Cancer, Metastatic, Platelet
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Plavix and Aspirin
Arm Type
Experimental
Arm Description
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.
Arm Title
Observation only
Arm Type
No Intervention
Arm Description
Observation by treating physician
Intervention Type
Drug
Intervention Name(s)
Plavix
Other Intervention Name(s)
Clopidogrel Bisulfate
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
acetylsalicylic acid
Primary Outcome Measure Information:
Title
Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs
Description
Measured by number of patients who have detectable circulating tumor cells
Time Frame
Week 4
Title
Safety and Tolerability of Aspirin and Plavix Measured by the Number of Patients Who Discontinue the Study Drug
Description
Measured by number of patients who discontinue administration of study drug because of toxicity and the incidence categorized by type.
Time Frame
Maximum of 6 months
Secondary Outcome Measure Information:
Title
Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time
Description
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
Time Frame
Baseline, 2 weeks and 1 month
Title
Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups
Description
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).
Time Frame
Baseline, 2 weeks and 1 month
Title
Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups
Description
Mean Clopidogrel-Mediated platelet inhibition (% inhibition) vs. time for Aspirin and Plavix and Observation groups
Time Frame
Baseline, 2 weeks and 1 month
Title
Progression Free Survival
Time Frame
Maximum of 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine N Weilbaecher, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients
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