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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00263211
• Other study ID #: 05-0427 / 201107340
• Status: Completed
• Phase: Phase 2
• First received: December 6, 2005
• Last updated: August 9, 2013
• Start date: January 2006
• Est. completion date: September 2009

Study information

• Verified date: August 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Plavix/Aspirin

Locations

Country	Name	City	State
United States	Washington University	St. Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Barnes-Jewish Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Safety and tolerability of this combination in patients with metastatic breast cancer.	Proportion of patients who discontinue administration of study drug because of toxicity and the incidence categorized by type.	Maximum of 6 months	Yes
Secondary	Absolute number of circulating tumor cells		Maximum of 6 months	No
Secondary	Platelet functions		Maximum of 6 months	No
Secondary	Progression free survival		Maximum of 6 months	No
Secondary	Overall survival		Maximum of 6 months	No

External Links

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