The Effect of Aspirin on Angiogenesis Proteins in Women on Tamoxifen Therapy
Information source: University of Vermont
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer; Angiogenesis
Intervention: Aspirin (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Vermont Official(s) and/or principal investigator(s):
Chris E Holmes, MD, PhD, Principal Investigator, Affiliation: University of Vermont
Overall contact:
Karen Wilson, Email: karen.wilson@uvm.edu
Summary
Changes in major angiogenic proteins have been seen following initiation of tamoxifen and
aromatase inhibitor therapy in women with breast cancer. One source of these proteins is the
circulating platelet pool. The investigators hypothesize that in addition to their
anti-platelet properties, agents such as aspirin can be used as targeted anti-angiogenesis
therapy. The investigators will determine the influence of aspirin on the release of
angiogenic proteins from platelets in 35 patients with breast cancer.
Clinical Details
Official title: The Impact of the Anti-Platelet Agent Aspirin on Angiogenesis Proteins in Women With Breast Cancer
Study design: Treatment, Open Label, Single Group Assignment
Primary outcome: Changes in pro-angiogenic and anti-angiogenic protein levels.
Eligibility
Minimum age: 18 Years.
Maximum age: 95 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Histologically or cytologically proven breast cancer
- Pre or post-menopausal
- Age >18
- Completed adjuvant non-hormonal therapy >30 days prior to initiation of study (surgery
and/or chemotherapy and/or radiation therapy)
- Platelet count and hemoglobin within normal ranges for local lab within 30 days of
initiation of study therapy
- Receiving tamoxifen therapy for at least 90 days prior to initiation of study therapy,
and is expected to continue that therapy for the duration of the study (75 days)
Exclusion Criteria:
- Chemotherapy, radiation therapy or surgery within 30 days of study therapy
- Current use of aspirin, anti-platelet or anti-coagulation agents on a continuous
basis
- Prior history of gastrointestinal or central nervous system bleeding, or documented or
self-reported blood in stools or bright red blood per rectum
Locations and Contacts
Karen Wilson, Email: karen.wilson@uvm.edu
University of Vermont, Burlington, Vermont 05401, United States; Recruiting
Karen Wilson, Email: karen.wilson@uvm.edu
Chris E. Holmes, M.D., Ph.D., Principal Investigator
Additional Information
Starting date: July 2008
Ending date: February 2009
Last updated: July 30, 2008
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