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The Impact Of Platelet Function Inhibition On Circulating Cancer Cells In Metastatic Breast Cancer Patients


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

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Trial Information

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.

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.


Inclusion Criteria:



- Women with metastatic breast cancer who are completing planned course of therapy 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Effect of platelet inhibition on circulating tumor cell number in women with metastatic breast cancer

Outcome Description:

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).

Outcome Time Frame:

Maximum of 6 months

Safety Issue:

Yes

Principal Investigator

Katherine Weilbaecher, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

05-0427 / 201107340

NCT ID:

NCT00263211

Start Date:

January 2006

Completion Date:

September 2009

Related Keywords:

  • Breast Neoplasms
  • Breast Cancer
  • Metastatic
  • Platelet
  • Breast Neoplasms
  • Neoplasms

Name

Location

Washington UniversitySt. Louis, Missouri  63110