NCT00280930

Brief Summary

The purpose of this study to see what happens to breast density in healthy postmenopausal women after treatment with letrozole in one year, compared with treatment with placebo for one year. Other goals of the study include determining if there is a connection between estrogen level and breast density for women in the study and collecting information about the quality of life of those taking part in the study.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

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

October 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 24, 2006

Completed
Last Updated

January 19, 2007

Status Verified

January 1, 2007

First QC Date

January 23, 2006

Last Update Submit

January 18, 2007

Conditions

Post-MenopausalBreast Cancer

Keywords

letrozolebreast cancermenopause

Outcome Measures

Primary Outcomes (1)

  • To determine the proportion of women with breast density of > grade 4 who have a decrease in breast density of at least one grade after treatment with letrozole for one year.

Secondary Outcomes (6)

  • To determine if the decrease in breast density grade is sustained one year after cessation of therapy

  • to determine if there is a correlation between plasma estrogen profile and breast density at baseline

  • to determine the percentage of subjects with breast tissue hyperplasia and atypical hyperplasia before and after therapy

  • to assess change in estrogen profile from baseline and at 1 year and 1 year after cessation of therapy

  • to assess the general safety of the utilization of letrozole in healthy post-menopausal women for one year

  • +1 more secondary outcomes

Interventions

LetrozoleDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal status defined as: women \>55 years of age-no spontaneous menses for at least 12 months; in women \< 55 years-no spontaneous menses within the past 12 months and with an FSH level \>34.4 IU/I; bilateral oophorectomy
  • If subject had prior invasive breast cancer it must have been surgically removed at the time of orginal diagnosis with no evidence of metastases and the primary tumor may be receptive negative, positive or equivocal
  • Baseline mammogram (within 6 months) indicating mammographic density occupying \>25% (grade 4/5, 5/6 or 6/6) of the breast tissue
  • Baseline breast examination demonstrating no clinical evidence of breast cancer
  • Acceptable quality DEXA of the L2-L4 postero-anterior (PA) spine and hup must be performed 6 months of randomization
  • Subject is willing and able to complete the quality of life questionnaire in either English or French

You may not qualify if:

  • Mammogram suspicious for breast cancer (unless subsequently ruled out)
  • Patient's with prior malignancies are eligible unless they have metastatic disease
  • Uncontrolled metabolic or endocrine disease, cardiovascular disease or malabsorption syndrome
  • Current chemotherapy or immunotherapy
  • Hormone replacement therapy or Evista (raloxifene) discontinued less than three months before baseline mammogram
  • Tamoxifen therapy discontinued less than six months prior to randomization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Paul Goss, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 23, 2006

First Posted

January 24, 2006

Study Start

October 1, 2005

Last Updated

January 19, 2007

Record last verified: 2007-01

Locations

US(3)