Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

The Impact of Tamoxifen and Aromatase Inhibitors on Platelet Proteins

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Vermont.
Recruitment status was  Active, not recruiting
American Cancer Society, Inc.
Information provided by:
University of Vermont Identifier:
First received: July 7, 2010
Last updated: April 21, 2011
Last verified: April 2011

Single phlebotomy study involving women receiving tamoxifen or aromatase inhibitor therapy.

Breast Cancer

Study Type: Observational
Official Title: Platelet Modulation in the Control of Angiogenesis: The Impact of Tamoxifen and Aromatase Inhibitors on Platelet Activation and Angiogenic Proteins

Resource links provided by NLM:

Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Angiogenic Protein levels [ Time Frame: following 6 months of therapy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum, plasma, platelet activated samples

Estimated Enrollment: 60
Study Start Date: August 2009
Estimated Study Completion Date: September 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
tamoxifen or aromatase inhibitors


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women using tamoxifen or aromatase inhibitor therapy for greater than 6 months


Inclusion Criteria:

  • women routinely taking tamoxifen or aromatase inhibitor therapy as prescribed by their oncologist

Exclusion Criteria:

  • Use of heparin, warfarin
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01341171

United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
American Cancer Society, Inc.
Principal Investigator: Chris E Holmes, MD, PhD University of Vermont
  More Information

No publications provided

Responsible Party: Chris E. Holmes, MD, PhD, University of Vermont Identifier: NCT01341171     History of Changes
Other Study ID Numbers: V0805
Study First Received: July 7, 2010
Last Updated: April 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Vermont:
aromatase inhibitors
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Aromatase Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Bone Density Conservation Agents
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Therapeutic Uses processed this record on February 26, 2015