Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer

NCT00014638 | Completed Phase 4

• 2 other identifiers: CDR0000068583NOVARTIS-CFEM345A-US10
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 20

Brief Summary

RATIONALE: Estrogen can stimulate the growth of cancer cells. Letrozole may fight breast cancer by reducing the production of estrogen. PURPOSE: Phase IV trial to study the effectiveness of letrozole in treating postmenopausal women who have metastatic breast cancer that has been previously treated with tamoxifen.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

letrozole DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Diagnosis of metastatic breast cancer Measurable or evaluable disease Postmenopausal No spontaneous menses for at least 5 years (including chemotherapy-induced amenorrhea) Spontaneous menses within the past 5 years allowed if amenorrheic for at least 12 months and LH and FSH in postmenopausal normal range (including chemotherapy-induced amenorrhea) Bilateral oophorectomy Radiotherapy castration and amenorrheic for at least 3 months Hormone receptor status: Estrogen-receptor (ER) and/or progesterone-receptor (PR) positive No ER and PR negative or unknown tumors PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: See Disease Characteristics Performance status: Karnofsky 50-100% WHO 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Corrected serum calcium less than 11.6 mg/dL Other: No known hypersensitivity to any of the constituents of the study drug No history of noncompliance to medical regimens No unreliability Not pregnant or nursing Fertile patients must use effective contraception HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent anticancer immunotherapy or biological response modifiers Chemotherapy: See Disease Characteristics Prior adjuvant or neoadjuvant chemotherapy with adjuvant tamoxifen allowed No concurrent anticancer chemotherapy Endocrine therapy: See Chemotherapy No other concurrent anticancer endocrine therapy (including steroids) Radiotherapy: See Disease Characteristics No concurrent radiotherapy to sole site of disease Concurrent radiotherapy to a limited area (e.g., for painful disease) allowed Surgery: See Disease Characteristics No prior adrenalectomy or hypophysectomy Other: At least 30 days since prior systemic investigational drugs At least 7 days since prior topical investigational drugs No other concurrent investigational drugs Concurrent bisphosphonates (e.g., zoledronic acid) for bone metastasis allowed

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

Sponsors & Collaborators

• Novartis: lead

Study Sites (20)

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Long Beach Memorial Breast Center

Long Beach, California, 90806, United States

Location

Cancer Research Network, Inc.

Hollywood, Florida, 33020, United States

Location

Oncology-Hematology Group of South Florida

Miami, Florida, 33176, United States

Location

Pharm Research

Pinecrest, Florida, 33156, United States

Location

Cancer Research Network Inc.

Plantation, Florida, 33324, United States

Location

Good Samaritan Medical Center

West Palm Beach, Florida, 33401, United States

Location

Illinois Oncology, Ltd.

Belleville, Illinois, 62221, United States

Location

Joliet Oncology/Hematology Associates, Ltd.

Joliet, Illinois, 60435, United States

Location

Memorial Medical Center

Springfield, Illinois, 62781, United States

Location

Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

Southwest Oncology Association

Lafayette, Louisiana, 70503, United States

Location

New Mexico Oncology-Hematology

Albuquerque, New Mexico, 87109, United States

Location

Albert Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

Location

Oncology Partnership Network

Cincinnati, Ohio, 45238, United States

Location

Memphis Cancer Center

Memphis, Tennessee, 38119, United States

Location

Dial Research Associates, Inc.

Nashville, Tennessee, 37205, United States

Location

Center for Oncology Research and Treatment, Medical City Hospital

Dallas, Texas, 75230, United States

Location

Intermountain Hematology/Oncology Associates, Inc.

Salt Lake City, Utah, 84124, United States

Location

Cascade Cancer Center

Kirkland, Washington, 98034-3013, United States

Location

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

• Stephanie Petrone, SCRS

  Novartis Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2001
• First Posted: November 13, 2003
• Study Start: January 1, 2001
• Primary Completion: March 1, 2002
• Study Completion: March 1, 2002
• Last Updated: February 21, 2013

Record last verified: 2013-02

Locations

US (20)