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

This study has been completed.
Sponsor:
Collaborator:
Barnes-Jewish Hospital
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00263211
First received: December 6, 2005
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Breast Neoplasms
Drug: Plavix/Aspirin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Impact Of Platelet Function Inhibition On Circulating Cancer Cells In Metastatic Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Effect of platelet inhibition on circulating tumor cell number in women with metastatic breast cancer [ Time Frame: Maximum of 6 months ] [ Designated as safety issue: Yes ]
    Proportion of patients who have detectable circulating tumor cells after completion of study (at the time of either resuming systemic treatment of breast cancer or unacceptable toxicity being observed).

  • Safety and tolerability of this combination in patients with metastatic breast cancer. [ Time Frame: Maximum of 6 months ] [ Designated as safety issue: Yes ]
    Proportion of patients who discontinue administration of study drug because of toxicity and the incidence categorized by type.


Secondary Outcome Measures:
  • Absolute number of circulating tumor cells [ Time Frame: Maximum of 6 months ] [ Designated as safety issue: No ]
  • Platelet functions [ Time Frame: Maximum of 6 months ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: Maximum of 6 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Maximum of 6 months ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: January 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
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/Aspirin
Other Names:
  • Plavix=Clopidogrel Bisulfate
  • Aspirin=acetylsalicylic acid
No Intervention: Arm 2
Observation by treating physician

Detailed Description:

All patients will have medical history, physical exam, and standard labs at baseline, including platelets, AST/ALT, creatinine, PT/PTT. Platelet function, CTC tests, and Urine Ntx will be taken at baseline, two weeks, and then monthly. Patients may remain on study until treating physician elects to resume systemic therapy. If patients continue on study after one month, they will receive physical exam, medical history/progress notes, standard labs, platelet function (at the treating physician's discretion), and CTC tests on a monthly (q 4 week) schedule or every 3 weeks if receiving trastuzumab or other i.v. medication that necessitates returning to the clinic on an every 3 week schedule.

Plavix/Aspirin Arm

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.

No Treatment Arm

Patients randomized to the no treatment arm will receive no anti-platelet drugs but will be monitored by the treating physician. Assessment of performance status, quality of life, CTC, and platelet function will be performed. Patients will continue on the study until the treating physician elects to resume systemic therapy for the treatment of breast cancer, or until unacceptable toxicity is observed. Patients will be followed for 6 months maximum as part of the protocol.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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:

    • AST/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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00263211

Locations
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Barnes-Jewish Hospital
Investigators
Principal Investigator: Katherine Weilbaecher, M.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00263211     History of Changes
Other Study ID Numbers: 05-0427 / 201107340
Study First Received: December 6, 2005
Last Updated: August 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Breast Cancer
Metastatic
Platelet

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists

ClinicalTrials.gov processed this record on July 29, 2014