Letrozole in Postmenopausal Women at Increased Risk for Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Dana-Farber Cancer Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by:
Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00280930
First received: January 23, 2006
Last updated: January 18, 2007
Last verified: January 2007
  Purpose

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.


Condition Intervention Phase
Post-Menopausal
Breast Cancer
Drug: Letrozole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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
  • to compare the effects on menopause-specific quality of life.

Estimated Enrollment: 60
Study Start Date: October 2005
Detailed Description:
  • Patients will be randomized into one of two study groups. Group 1 will receive letrozole and Group 2 will receive placebo. This is a double-blind trial so neither the patient or the doctor will know what treatment group they are assigned to.
  • If the patient is in Group 1 they will take letrozole tablets orally once a day with food for one year. Patients in Group 2 will take a placebo tablet orally once a day with food for one year.
  • Patients in both groups will also be given calcium tablets (500mg) and vitamin D tablets (400IU) once a day for one year.
  • After the initial screening visits, the patient will return to the clinic at 3, 6, 9 and 12 months (a total of up to 6 visits in the first year). There will also be two follow-up visits at 18 and 24 months. For the 3, 9 and 18 month visits, telephone contact instead of a clinic visit is allowed.
  • The following tests and procedures will be performed during these visits:

evaluation of side effects; routine blood tests(6, 12, and 24 month visits); urine sample (6 and 12 month visits); complete physical exam including breast exam (12 and 24 month visits); mammogram (12 and 24 month visits); bone marrow density x-ray test (12 and 24 month visits); standard x-rays of the lower back and chest (12 month visit); and a questionnaire about how the patient is feeling (12 and 24 month visits).

  • The length of participation in this study is for 1 year of study treatment followed by 1 year of follow-up.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00280930

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
Principal Investigator: Paul Goss, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00280930     History of Changes
Other Study ID Numbers: 05-183, NCIC CTG MAP.1
Study First Received: January 23, 2006
Last Updated: January 18, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
letrozole
breast cancer
menopause

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014