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Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00014638
Collaborator
(none)
20
Locations
13.9
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
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 Start Date :
Jan 1, 2001
Actual Primary Completion Date :
Mar 1, 2002
Actual Study Completion Date :
Mar 1, 2002

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alta Bates Comprehensive Cancer Center Berkeley California United States 94704
    2 Long Beach Memorial Breast Center Long Beach California United States 90806
    3 Cancer Research Network, Inc. Hollywood Florida United States 33020
    4 Oncology-Hematology Group of South Florida Miami Florida United States 33176
    5 Pharm Research Pinecrest Florida United States 33156
    6 Cancer Research Network Inc. Plantation Florida United States 33324
    7 Good Samaritan Medical Center West Palm Beach Florida United States 33401
    8 Illinois Oncology, Ltd. Belleville Illinois United States 62221
    9 Joliet Oncology/Hematology Associates, Ltd. Joliet Illinois United States 60435
    10 Memorial Medical Center Springfield Illinois United States 62781
    11 Carle Cancer Center Urbana Illinois United States 61801
    12 Southwest Oncology Association Lafayette Louisiana United States 70503
    13 New Mexico Oncology-Hematology Albuquerque New Mexico United States 87109
    14 Albert Einstein Comprehensive Cancer Center Bronx New York United States 10461
    15 Oncology Partnership Network Cincinnati Ohio United States 45238
    16 Memphis Cancer Center Memphis Tennessee United States 38119
    17 Dial Research Associates, Inc. Nashville Tennessee United States 37205
    18 Center for Oncology Research and Treatment, Medical City Hospital Dallas Texas United States 75230
    19 Intermountain Hematology/Oncology Associates, Inc. Salt Lake City Utah United States 84124
    20 Cascade Cancer Center Kirkland Washington United States 98034-3013

    Sponsors and Collaborators

    • Novartis

    Investigators

    • Study Chair: Stephanie Petrone, SCRS, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis
    ClinicalTrials.gov Identifier:
    NCT00014638
    Other Study ID Numbers:
    • CDR0000068583
    • NOVARTIS-CFEM345A-US10
    First Posted:
    Nov 13, 2003
    Last Update Posted:
    Feb 21, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Novartis
    stage IV breast cancer
    recurrent breast cancer
    Additional relevant MeSH terms:
    Breast Neoplasms
    Letrozole

    Study Results

    No Results Posted as of Feb 21, 2013