Clinical trial · Interventional
A Study of the Effects of Inhibiting Platelet Function on Circulating Cancer Cells in Breast Cancer Patients
The Impact Of Platelet Function Inhibition On Circulating Cancer Cells In Metastatic Breast Cancer Patients
NCT00263211CI-TRIAL-00026478terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Stopped due to low percentage of patients with detectable CTCs at baseline.
Summary
Brief summary (as posted)
The purpose of this study is to determine the effects of Plavix and aspirin in women with metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aspirin | Drug | Aspirin | ALIAS |
| Plavix | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Plavix and Aspirin
- 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.
- interventionNames
- Drug: Plavix
- Drug: Aspirin
- type
- NO_INTERVENTION
- label
- Observation only
- description
- Observation by treating physician
Primary outcomes (2)
- measure
- Platelet Inhibition of Circulating Tumor Cells (CTCs) Measured by the Number of Patients With Detectable CTCs
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.