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

Study Description

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Brief Summary:

The purpose of this study is to determine the effects of Plavix and aspirin in women with metastatic breast cancer.

Condition or disease	Intervention/treatment	Phase
Breast Neoplasms	Drug: Plavix; Drug: Aspirin	Phase 2

Study Design

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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

Arms and Interventions

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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.	Drug: Plavix; Other Name: Clopidogrel Bisulfate Drug: Aspirin; Other Name: acetylsalicylic acid
No Intervention: Observation only; Observation by treating physician

Outcome Measures

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Primary Outcome Measures :

1. 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
2. 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.

Secondary Outcome Measures :

1. 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
2. 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).
3. 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
4. Progression Free Survival [ Time Frame: Maximum of 6 months ]

Eligibility Criteria

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

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

Contacts and Locations

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Locations

United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

Barnes-Jewish Hospital

Investigators

Principal Investigator:	Katherine N Weilbaecher, M.D.	Washington University School of Medicine

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine 

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00263211 History of Changes
Other Study ID Numbers:	05-0427 / 201107340
First Posted:	December 7, 2005
Results First Posted:	March 15, 2017
Last Update Posted:	March 15, 2017
Last Verified:	January 2017

Keywords provided by Washington University School of Medicine:

Breast Cancer; Metastatic; Platelet

Additional relevant MeSH terms:

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