The Effect of Aspirin on Angiogenesis Proteins in Women on Tamoxifen Therapy

Breast Cancer Clinical Trial

Official title:

The Impact of the Anti-Platelet Agent Aspirin on Angiogenesis Proteins in Women With Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00727948
• Other study ID #: V0801
• Status: Completed
• Phase: Early Phase 1
• Start date: July 2008
• Est. completion date: December 2012

Study information

• Verified date: June 2010
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: December 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Angiogenesis
• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Aspirin
325 mg tablets, once daily for 45 days

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pro-angiogenic and anti-angiogenic protein levels.		75 days