The Impact Of Platelet Function Inhibition On Circulating Cancer Cells In Metastatic Breast Cancer Patients
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.
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Effect of platelet inhibition on circulating tumor cell number in women with metastatic breast cancer
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).
Maximum of 6 months
Katherine Weilbaecher, M.D.
Washington University School of Medicine
United States: Institutional Review Board
05-0427 / 201107340
|Washington University||St. Louis, Missouri 63110|