Letrozole in Preventing Breast Cancer in Postmenopausal Women Who Are at Increased Risk for Breast Cancer Due to High Breast Density - Full Text View

Sponsored by:	National Cancer Institute of Canada
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00238316

Purpose

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of letrozole may stop cancer from forming or coming back in postmenopausal women who are at increased risk for breast cancer due to high breast density.

PURPOSE: This randomized phase II trial is studying how well letrozole works in preventing breast cancer in postmenopausal women who are at increased risk for breast cancer due to high breast density.

Condition	Intervention	Phase
Breast Cancer	Drug: letrozole	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Letrozole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Percentage change of the BMD parameters from baseline BMD values [ Designated as safety issue: No ]
Percentage change of bone biomarker measurements (serum bone alkaline phosphatase and urine N-telopeptide) from baseline values [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	December 2000

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00238316

Locations

United States, Massachusetts
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115-6084
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Hamilton Osteoporosis Diagnostic Services
Hamilton, Ontario, Canada, L8N 1Y2
Ottawa Hospital Regional Cancer Centre - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
St. Catharines General Hospital at Niagara Health System
St. Catharines, Ontario, Canada, L2R 5K3
Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Hotel Dieu de Montreal
Montreal, Quebec, Canada, H2W 1T8

Sponsors and Collaborators

National Cancer Institute of Canada

Investigators

Study Chair:

Paul E. Goss, MD, PhD

Massachusetts General Hospital

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000445442, CAN-NCIC-MAP1
Study First Received:	October 12, 2005
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00238316
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Letrozole
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009