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A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Post-Menopausal, Breast Cancer

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Trial Information

A Randomized Feasibility Study of Letrozole in Postmenopausal Women at Increased Risk for Development of Breast Cancer as Evidenced by High Breast Density


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

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.

Principal Investigator

Paul Goss, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

05-183

NCT ID:

NCT00280930

Start Date:

October 2005

Completion Date:

Related Keywords:

  • Post-Menopausal
  • Breast Cancer
  • letrozole
  • breast cancer
  • menopause
  • Breast Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617