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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by University of Vermont.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Vermont
ClinicalTrials.gov Identifier:
NCT00727948
First received: July 30, 2008
Last updated: April 21, 2011
Last verified: June 2010
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
Angiogenesis
 Drug: Aspirin
 Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of the Anti-Platelet Agent Aspirin on Angiogenesis Proteins in Women With Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Changes in pro-angiogenic and anti-angiogenic protein levels. [ Time Frame: 75 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: July 2008
Estimated Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Aspirin
    325 mg tablets, once daily for 45 days
  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00727948

Locations
United States, Vermont
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
  More Information

No publications provided

Responsible Party: Chris E. Holmes, M.D., Ph.D., University of Vermont
ClinicalTrials.gov Identifier: NCT00727948     History of Changes
Other Study ID Numbers: V0801
Study First Received: July 30, 2008
Last Updated: April 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Vermont:
Breast cancer
Angiogenesis
Aspirin
Tamoxifen

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Aspirin
Platelet Aggregation Inhibitors
Tamoxifen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators

ClinicalTrials.gov processed this record on May 23, 2013