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

NCT ID: NCT00727948

Last Updated: 2020-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Angiogenesis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

receive aspirin

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

325 mg tablets, once daily for 45 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aspirin

325 mg tablets, once daily for 45 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

95 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Vermont

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chris Holmes

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chris E Holmes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Vermont

Burlington, Vermont, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

V0801

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ASPREE Cancer Endpoints Study
NCT01968798 UNKNOWN PHASE4