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

Phase 2TerminatedNCT00263211

Washington University School of Medicine48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Breast Neoplasms

Interventions

PlavixDRUG

AspirinDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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

Time frame: Week 4

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.

Time frame: Maximum of 6 months

Secondary Outcomes

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

Time frame: Baseline, 2 weeks and 1 month

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).

Time frame: Baseline, 2 weeks and 1 month

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

Time frame: Baseline, 2 weeks and 1 month

Data from ClinicalTrials.gov

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