The Effect of Aspirin on Angiogenesis Proteins in Women on Tamoxifen Therapy
The Impact of the Anti-Platelet Agent Aspirin on Angiogenesis Proteins in Women With Breast Cancer
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1 breast-cancer
Started Jul 2008
Longer than P75 for early_phase_1 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 30, 2008
CompletedFirst Posted
Study publicly available on registry
August 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedSeptember 17, 2020
June 1, 2010
2.4 years
July 30, 2008
September 15, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in pro-angiogenic and anti-angiogenic protein levels.
75 days
Study Arms (1)
receive aspirin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Vermont
Burlington, Vermont, 05401, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chris E Holmes, MD, PhD
University of Vermont
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine
Study Record Dates
First Submitted
July 30, 2008
First Posted
August 4, 2008
Study Start
July 1, 2008
Primary Completion
December 1, 2010
Study Completion
December 1, 2012
Last Updated
September 17, 2020
Record last verified: 2010-06