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
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Condition or disease | Intervention/treatment | Phase |
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Breast Neoplasms | Drug: Plavix Drug: Aspirin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | The Impact Of Platelet Function Inhibition On Circulating Cancer Cells In Metastatic Breast Cancer Patients |
Study Start Date : | January 2006 |
Actual Primary Completion Date : | September 2009 |
Actual Study Completion Date : | September 2009 |

Arm | Intervention/treatment |
---|---|
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.
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Drug: Plavix
Other Name: Clopidogrel Bisulfate Drug: Aspirin Other Name: acetylsalicylic acid |
No Intervention: Observation only
Observation by treating physician
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- 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.
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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)
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00263211
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Katherine N Weilbaecher, M.D. | Washington University School of Medicine |
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov Identifier: | NCT00263211 |
Other Study ID Numbers: |
05-0427 / 201107340 |
First Posted: | December 7, 2005 Key Record Dates |
Results First Posted: | March 15, 2017 |
Last Update Posted: | March 15, 2017 |
Last Verified: | January 2017 |
Breast Cancer Metastatic Platelet |
Breast Neoplasms Neoplasms by Site Neoplasms 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 Anti-Inflammatory Agents |
Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents |