NCT00005605

Brief Summary

RATIONALE: Tamoxifen may be able to increase bone density and decrease cholesterol in women who are undergoing chemotherapy for breast cancer. PURPOSE: Clinical trial to study the effectiveness of tamoxifen in preventing bone loss and heart disease caused by chemotherapy treatment in premenopausal women who have stage I or stage II breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

February 1, 2000

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2000

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

February 21, 2011

Status Verified

February 1, 2011

Enrollment Period

5.7 years

First QC Date

May 2, 2000

Last Update Submit

February 18, 2011

Conditions

Breast CancerOsteoporosis

Keywords

osteoporosisstage I breast cancerstage II breast cancer

Study Arms (2)

Tamoxifen group

Chemotherapy group

Eligibility Criteria

Age35 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with stage I or II breast cancer currently undergoing treatment with either chemotherapy or tamoxifen.

DISEASE CHARACTERISTICS: * Histologically proven stage I or II breast cancer * Must be scheduled to receive adjuvant chemotherapy with or without tamoxifen * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 35 to 50 Sex: * Female Menopausal status: * Premenopausal by follicle-stimulating hormone and estradiol levels Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics Endocrine therapy: * See Disease characteristics Radiotherapy: * Not specified Surgery: * Not specified

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

Sponsors & Collaborators

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsOsteoporosis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Seema A. Khan, MD

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 2, 2000

First Posted

January 27, 2003

Study Start

February 1, 2000

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

February 21, 2011

Record last verified: 2011-02

Locations

US(1)