Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

December 6, 2005
August 9, 2013
January 2006
September 2009   (final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT00263211 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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

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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Breast Neoplasms
Drug: Plavix/Aspirin
Other Names:
  • Plavix=Clopidogrel Bisulfate
  • Aspirin=acetylsalicylic acid
  • 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.
    Intervention: Drug: Plavix/Aspirin
  • No Intervention: Arm 2
    Observation by treating physician
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00263211
05-0427 / 201107340
No
Washington University School of Medicine
Washington University School of Medicine
Barnes-Jewish Hospital
Principal Investigator: Katherine Weilbaecher, M.D. Washington University School of Medicine
Washington University School of Medicine
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP