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

Sponsor
University of Vermont (Other)
Overall Status
Completed
CT.gov ID
NCT00727948
Collaborator
(none)
11
Enrollment
1
Location
1
Arm
53
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Impact of the Anti-Platelet Agent Aspirin on Angiogenesis Proteins in Women With Breast Cancer
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: receive aspirin

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

Outcome Measures

Primary Outcome Measures

  1. Changes in pro-angiogenic and anti-angiogenic protein levels. [75 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 95 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Vermont Burlington Vermont United States 05401

Sponsors and Collaborators

  • University of Vermont

Investigators

  • Principal Investigator: Chris E Holmes, MD, PhD, University of Vermont

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chris Holmes, Associate Professor of Medicine, University of Vermont
ClinicalTrials.gov Identifier:
NCT00727948
Other Study ID Numbers:
  • V0801
First Posted:
Aug 4, 2008
Last Update Posted:
Sep 17, 2020
Last Verified:
Jun 1, 2010
Keywords provided by Chris Holmes, Associate Professor of Medicine, University of Vermont
Breast cancer
Angiogenesis
Aspirin
Tamoxifen
Additional relevant MeSH terms:
Breast Neoplasms
Aspirin

Study Results

No Results Posted as of Sep 17, 2020