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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
N/A
N/A
Not Enrolling
Female
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


OBJECTIVES:

Primary

- Determine the proportion of postmenopausal women who are at increased risk for the
development or recurrence of breast cancer, based on high breast density (≥ grade 4),
who achieve a decrease in breast density of ≥ 1 grade after treatment with letrozole
for 1 year.

Secondary

- Determine whether a decrease in breast density grade is sustained at 1 year in patients
treated with this drug.

- Correlate plasma estrogen profile (E1, E1S, E2) with breast density grade at baseline
in these patients.

- Determine the percentage of patients with breast tissue hyperplasia and atypical
hyperplasia, as assessed by histopathological examination of breast tissue biopsies,
before and after treatment with this drug.

- Determine the changes in estrogen profile from baseline, at 1 year, and 1 year after
cessation of this drug in these patients.

- Compare changes in predetermined specific parameters of safety at the end of 1 year of
treatment with this drug with baseline evaluations of these patients.

- Determine whether modifications of these predetermined specific parameters of safety
are sustained 1 year after cessation of treatment with this drug in these patients.

- Determine the general safety of 1 year of treatment with this drug in these patients.

- Compare the effects of this drug on menopause-specific quality of life of these
patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to breast density grade (4/6 vs 5/6 vs 6/6). Patients are
randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral letrozole once daily for 1 year in the absence of
unacceptable toxicity.

- Arm II: Patients receive oral placebo once daily for 1 year in the absence of
unacceptable toxicity.

Menopause-specific quality of life is assessed at baseline and then at 12 and 24 months.

After completion of study treatment, patients are followed at 6 months and 1 year.

PROJECTED ACCRUAL: A total of 120 patients (80 in arm I and 40 in arm II) will be accrued
for this study within 12 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- At increased risk for the development or recurrence of breast cancer, as defined by 1
of the following:

- Baseline mammogram indicating mammographic density occupying ≥ 25% (grade 4/6,
5/6, or 6/6) of the breast tissue

- No suspicion of breast cancer, unless subsequently ruled out

- Prior ductal carcinoma in situ (DCIS)

- Untreated disease OR > 6 months since completion of adjuvant endocrine
therapy

- Receptor status of lesion is not required

- Prior invasive breast cancer

- Breast cancer must have been surgically removed at time of original
diagnosis with no evidence of metastases

- No clinical evidence of breast cancer

- Acceptable quality dual-energy x-ray absorptiometry (DEXA) of the L2-L4
postero-anterior (PA) spine and hip performed within past 6 months

- Bone mass density T-score of either PA spine or hip must be ≥ 2.0 SD below the
mean peak bone mass in young normal woman

- Stable chronic leukemia allowed

- Hormone receptor status:

- Hormone receptor-negative, -positive, or -equivocal tumor

PATIENT CHARACTERISTICS:

Age

- Postmenopausal

Sex

- Female

Menopausal status

- Postmenopausal, as defined by 1 of the following:

- Over 55 years of age with spontaneous cessation of menses for ≥ 1 year

- 55 years of age and under with spontaneous cessation of menses for ≤ 1 year, but
amenorrheic (e.g., spontaneous or secondary to hysterectomy) AND
follicle-stimulating hormone level > 34.4 IU/L

- Bilateral oophorectomy

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Not specified

Renal

- Not specified

Cardiovascular

- No recent unstable myocardial infarction

- No prior stroke

- No high blood pressure

- No other uncontrolled cardiovascular disease

Other

- Other prior malignancies without metastatic disease allowed

- Willing and able to complete quality of life questionnaires in either English or
French

- No uncontrolled metabolic or endocrine disease

- No malabsorption syndrome

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No concurrent immunotherapy

Chemotherapy

- No concurrent chemotherapy

Endocrine therapy

- See Disease Characteristics

- At least 3 months since prior and no concurrent hormone replacement therapy or
raloxifene

- At least 6 months since prior tamoxifen

- No concurrent steroid therapy

- No concurrent selective estrogen-receptor modulators

- No other concurrent endocrine or hormonal therapy

Radiotherapy

- Not specified

Surgery

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Outcome Measure:

Percentage change of the BMD parameters from baseline BMD values

Outcome Time Frame:

7 years

Safety Issue:

No

Principal Investigator

Paul E. Goss, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Federal Government

Study ID:

MAP1

NCT ID:

NCT00238316

Start Date:

December 2000

Completion Date:

February 2009

Related Keywords:

  • Breast Cancer
  • breast cancer
  • Breast Neoplasms

Name

Location

Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115