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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by University of Vermont.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00727948
First Posted: August 4, 2008
Last Update Posted: April 22, 2011
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.
Information provided by:
University of Vermont
  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 Early Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes 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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Chris E. Holmes, M.D., Ph.D., University of Vermont
ClinicalTrials.gov Identifier: NCT00727948     History of Changes
Other Study ID Numbers: V0801
First Submitted: July 30, 2008
First Posted: August 4, 2008
Last Update Posted: April 22, 2011
Last Verified: June 2010

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
Tamoxifen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
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
Antipyretics
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


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