Status:

COMPLETED

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

Lead Sponsor:

University of Vermont

Conditions:

Breast Cancer

Angiogenesis

Eligibility:

FEMALE

18-95 years

Phase:

EARLY_PHASE1

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 plate...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

July 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 1 2012

Estimated Enrollment :

11 Patients enrolled

Trial Details

Trial ID

NCT00727948

Start Date

July 1 2008

End Date

December 1 2012

Last Update

September 17 2020

Active Locations (1)

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1

University of Vermont

Burlington, Vermont, United States, 05401