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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00727948
Recruitment Status : Unknown
Verified June 2010 by University of Vermont.
Recruitment status was:  Active, not recruiting
First Posted : August 4, 2008
Last Update Posted : April 22, 2011
Information provided by:
University of Vermont

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
Breast Cancer Angiogenesis Drug: Aspirin Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
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 : July 2008
Primary Completion Date : December 2010
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Aspirin
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Changes in pro-angiogenic and anti-angiogenic protein levels. [ Time Frame: 75 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00727948

United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
Principal Investigator: Chris E Holmes, MD, PhD University of Vermont

Responsible Party: Chris E. Holmes, M.D., Ph.D., University of Vermont Identifier: NCT00727948     History of Changes
Other Study ID Numbers: V0801
First Posted: August 4, 2008    Key Record Dates
Last Update Posted: April 22, 2011
Last Verified: June 2010

Keywords provided by University of Vermont:
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents