Overview

This trial is active, not recruiting.

Conditions breast cancer, angiogenesis
Treatment aspirin
Phase phase 0
Sponsor University of Vermont
Start date July 2008
End date December 2010
Trial size 35 participants
Trial identifier NCT00727948, V0801

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Changes in pro-angiogenic and anti-angiogenic protein levels.
time frame: 75 days

Eligibility Criteria

Female participants from 18 years up to 95 years old.

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

Additional Information

Official title The Impact of the Anti-Platelet Agent Aspirin on Angiogenesis Proteins in Women With Breast Cancer
Principal investigator Chris E Holmes, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by University of Vermont.