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

NCT00263211 | Terminated Phase 2 Results

• 1 other identifier: 05-0427 / 201107340
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Neoplasms

Keywords

Breast Cancer; Metastatic; Platelet

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  Maximum of 6 months

Secondary Outcomes (4)

• Percentage of Patients With a Given Absolute Number of Circulating Tumor Cells (Broken Into Categories) Plotted Against Time

  Baseline, 2 weeks and 1 month

• Mean Aspirin-Mediated Platelet Inhibition vs. Time Plotted for Plavix and Aspirin and Observation Groups

  Baseline, 2 weeks and 1 month

• Clopidogrel-Mediated Percent of Platelet Inhibition vs. Time Plotted for Aspirin and Plavix and Observation Groups

  Baseline, 2 weeks and 1 month

• Progression Free Survival

  Maximum of 6 months

Study Arms (2)

Plavix and Aspirin

EXPERIMENTAL

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; Drug: Aspirin

Observation only

NO INTERVENTION

Observation by treating physician

Interventions

Plavix DRUG

Also known as: Clopidogrel Bisulfate

Plavix and Aspirin

Aspirin DRUG

Also known as: acetylsalicylic acid

Plavix and Aspirin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Barnes-Jewish Hospital: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

Inclusion of patients with no or few CTC's limited ability to distinguish anti-platelet therapeutic effect. Early termination because of low probability of reaching statistical significance for primary outcome

Results Point of Contact

• Title: Katherine Weilbacher, M.D,
• Organization: Department of Medicine Div. of Oncology, Washington University School of Medicine St. Louis MO

kweiblac@dom.wustl.edu

Fax: 314-454-8973

Study Officials

• Katherine N Weilbaecher, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2005
• First Posted: December 7, 2005
• Study Start: January 1, 2006
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 15, 2017
• Results First Posted: March 15, 2017

Record last verified: 2017-01

Locations

US (1)