NCT00000529

Brief Summary

To assess the impact of tamoxifen on development of breast cancer, coronary heart disease, and bone fractures. The National Cancer Institute initiated the prevention trial under its National Surgical Adjuvant Breast and Bowel Project (NSABP). The National Heart, Lung, and Blood Institute provided support to obtain blood pressure and lipid measurements, and lipoprotein and selected coagulation factor measurements in a subsample.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 1992

Shorter than P25 for phase_3 cardiovascular-diseases

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1992

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 1995

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

November 2, 2016

Status Verified

August 1, 2001

First QC Date

October 27, 1999

Last Update Submit

November 1, 2016

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesHypertensionMyocardial Ischemia

Interventions

tamoxifenDRUG

Eligibility Criteria

Age35 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Women over the age of 35 with a 5-year predicted breast cancer risk of at least 1.66 percent or a history of lobular breast carcinoma in situ, life expectancy of 10 years or more, breast examination and mammogram without evidence of cancer, no hormonal therapy within three months prior to randomization, and no history of deep venous thrombosis or pulmonary embolism. .

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • Reis SE, Costantino JP, Wickerham DL, Tan-Chiu E, Wang J, Kavanah M. Cardiovascular effects of tamoxifen in women with and without heart disease: breast cancer prevention trial. National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial Investigators. J Natl Cancer Inst. 2001 Jan 3;93(1):16-21. doi: 10.1093/jnci/93.1.16.

    PMID: 11136837BACKGROUND

  • Cushman M, Costantino JP, Tracy RP, Song K, Buckley L, Roberts JD, Krag DN. Tamoxifen and cardiac risk factors in healthy women: Suggestion of an anti-inflammatory effect. Arterioscler Thromb Vasc Biol. 2001 Feb;21(2):255-61. doi: 10.1161/01.atv.21.2.255.

    PMID: 11156862BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary DiseaseHeart DiseasesHypertensionMyocardial Ischemia

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Vascular Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
PREVENTION
Sponsor Type
NETWORK

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

May 1, 1992

Study Completion

November 1, 1995

Last Updated

November 2, 2016

Record last verified: 2001-08