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

NCT00238316 | Completed Phase 2 DMC

• 3 other identifiers: MAP1CAN-NCIC-MAP1CDR0000445442
• Study Type: interventional
• Target: 68
• Locations: 2 countries
• Sites: 10

Brief Summary

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.

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (2)

• Percentage change of the BMD parameters from baseline BMD values

  7 years

• Percentage change of bone biomarker measurements (serum bone alkaline phosphatase and urine N-telopeptide) from baseline values

  7 years

Study Arms (2)

Letrozole

ACTIVE COMPARATOR

Drug: letrozole

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

letrozole DRUG

2.5 mg PO daily for 1 year

Letrozole

Placebo OTHER

2.5 mg PO daily for one 1 year

Placebo

Eligibility Criteria

• Age: Up to 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead

Study Sites (10)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115-6084, United States

Location

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Nova Scotia Cancer Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Hamilton Osteoporosis Diagnostic Services

Hamilton, Ontario, L8N 1Y2, Canada

Location

Ottawa Hospital Regional Cancer Centre - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

St. Catharines General Hospital at Niagara Health System

St. Catharines, Ontario, L2R 5K3, Canada

Location

Toronto Sunnybrook Regional Cancer Centre at Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Hotel Dieu de Montreal

Montreal, Quebec, H2W 1T8, Canada

Location

Related Publications (1)

• Cigler T, Tu D, Yaffe MJ, Findlay B, Verma S, Johnston D, Richardson H, Hu H, Qi S, Goss PE. A randomized, placebo-controlled trial (NCIC CTG MAP1) examining the effects of letrozole on mammographic breast density and other end organs in postmenopausal women. Breast Cancer Res Treat. 2010 Apr;120(2):427-35. doi: 10.1007/s10549-009-0662-0. Epub 2009 Dec 6.

  PMID: 19967558 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Paul E. Goss, MD, PhD

  Massachusetts General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2005
• First Posted: October 13, 2005
• Study Start: December 5, 2000
• Primary Completion: November 16, 2007
• Study Completion: February 10, 2009
• Last Updated: April 2, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (8); US (2)