Clinical trial NCT00014638: Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Keywords: stage IV breast cancer
recurrent breast cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2003-11-13
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Alta Bates Comprehensive Cancer Center
state: California
city: Long Beach
country: United States
facility: Long Beach Memorial Breast Center
state: California
city: Hollywood
country: United States
facility: Cancer Research Network, Inc.
state: Florida
city: Miami
country: United States
facility: Oncology-Hematology Group of South Florida
state: Florida
city: Pinecrest
country: United States
facility: Pharm Research
state: Florida
city: Plantation
country: United States
facility: Cancer Research Network Inc.
state: Florida
city: West Palm Beach
country: United States
facility: Good Samaritan Medical Center
state: Florida
city: Belleville
country: United States
facility: Illinois Oncology, Ltd.
state: Illinois
city: Joliet
country: United States
facility: Joliet Oncology/Hematology Associates, Ltd.
state: Illinois
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Lafayette
country: United States
facility: Southwest Oncology Association
state: Louisiana
city: Albuquerque
country: United States
facility: New Mexico Oncology-Hematology
state: New Mexico
city: Bronx
country: United States
facility: Albert Einstein Comprehensive Cancer Center
state: New York
city: Cincinnati
country: United States
facility: Oncology Partnership Network
state: Ohio
city: Memphis
country: United States
facility: Memphis Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Dial Research Associates, Inc.
state: Tennessee
city: Dallas
country: United States
facility: Center for Oncology Research and Treatment, Medical City Hospital
state: Texas
city: Salt Lake City
country: United States
facility: Intermountain Hematology/Oncology Associates, Inc.
state: Utah
city: Kirkland
country: United States
facility: Cascade Cancer Center
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Stephanie Petrone, SCRS
role: STUDY_CHAIR
References: