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OpenTrials
Completed

NCT Number: NCT00727948

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

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.

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Key information

Conditions

Breast Cancer Angiogenesis Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–95 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Vermont

Burlington, Vermont, 05401, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aspirin

Drug

325 mg tablets, once daily for 45 days

Primary outcomes

  1. Changes in pro-angiogenic and anti-angiogenic protein levels.

    Time frame: 75 days

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Official study title

The Impact of the Anti-Platelet Agent Aspirin on Angiogenesis Proteins in Women With Breast Cancer

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
Aug 4, 2008
Registry last updated
Sep 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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