Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

Open Label, Multicenter Trial Of Femera (Letrozole) 2.5 mg As First-line Therapy In Postmenopausal Women With Metastatic Breast Cancer Relapsing Following Adjuvant Tamoxifen Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00014638
• Other study ID #: CDR0000068583
• Secondary ID: NOVARTIS-CFEM345
• Status: Completed
• Phase: Phase 4
• First received: April 10, 2001
• Last updated: February 20, 2013
• Start date: January 2001
• Est. completion date: March 2002

Study information

• Verified date: February 2013
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES: I. Determine the time to progression of postmenopausal women with metastatic breast cancer treated with letrozole (Femara) as first-line therapy. II. Determine the objective response rate, time to treatment failure, survival rate, and changes in symptom distress in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to time to diagnosis of metastatic disease. Patients receive oral letrozole (Femara) daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 590 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2002
• Est. primary completion date: March 2002
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• letrozole

Locations

Country	Name	City	State
United States	New Mexico Oncology-Hematology	Albuquerque	New Mexico
United States	Illinois Oncology, Ltd.	Belleville	Illinois
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	Albert Einstein Comprehensive Cancer Center	Bronx	New York
United States	Oncology Partnership Network	Cincinnati	Ohio
United States	Center for Oncology Research and Treatment, Medical City Hospital	Dallas	Texas
United States	Cancer Research Network, Inc.	Hollywood	Florida
United States	Joliet Oncology/Hematology Associates, Ltd.	Joliet	Illinois
United States	Cascade Cancer Center	Kirkland	Washington
United States	Southwest Oncology Association	Lafayette	Louisiana
United States	Long Beach Memorial Breast Center	Long Beach	California
United States	Memphis Cancer Center	Memphis	Tennessee
United States	Oncology-Hematology Group of South Florida	Miami	Florida
United States	Dial Research Associates, Inc.	Nashville	Tennessee
United States	Pharm Research	Pinecrest	Florida
United States	Cancer Research Network Inc.	Plantation	Florida
United States	Intermountain Hematology/Oncology Associates, Inc.	Salt Lake City	Utah
United States	Memorial Medical Center	Springfield	Illinois
United States	Carle Cancer Center	Urbana	Illinois
United States	Good Samaritan Medical Center	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States,