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

The Washington University

Status and phase: Terminated; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: Plavix; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT00263211

05-0427 / 201107340

Details and patient eligibility

About

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

Enrollment: 48 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Plavix and Aspirin

Experimental group

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.

Treatment:

Drug: Aspirin

Drug: Plavix

Observation only

No Intervention group

Description:

Observation by treating physician