Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00014638
First received: April 10, 2001
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Breast Cancer
Drug: letrozole
Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Study Start Date: January 2001
Study Completion Date: March 2002
Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00014638

Locations
United States, California
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
Long Beach Memorial Breast Center
Long Beach, California, United States, 90806
United States, Florida
Cancer Research Network, Inc.
Hollywood, Florida, United States, 33020
Oncology-Hematology Group of South Florida
Miami, Florida, United States, 33176
Pharm Research
Pinecrest, Florida, United States, 33156
Cancer Research Network Inc.
Plantation, Florida, United States, 33324
Good Samaritan Medical Center
West Palm Beach, Florida, United States, 33401
United States, Illinois
Illinois Oncology, Ltd.
Belleville, Illinois, United States, 62221
Joliet Oncology/Hematology Associates, Ltd.
Joliet, Illinois, United States, 60435
Memorial Medical Center
Springfield, Illinois, United States, 62781
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Louisiana
Southwest Oncology Association
Lafayette, Louisiana, United States, 70503
United States, New Mexico
New Mexico Oncology-Hematology
Albuquerque, New Mexico, United States, 87109
United States, New York
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
United States, Ohio
Oncology Partnership Network
Cincinnati, Ohio, United States, 45238
United States, Tennessee
Memphis Cancer Center
Memphis, Tennessee, United States, 38119
Dial Research Associates, Inc.
Nashville, Tennessee, United States, 37205
United States, Texas
Center for Oncology Research and Treatment, Medical City Hospital
Dallas, Texas, United States, 75230
United States, Utah
Intermountain Hematology/Oncology Associates, Inc.
Salt Lake City, Utah, United States, 84124
United States, Washington
Cascade Cancer Center
Kirkland, Washington, United States, 98034-3013
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Stephanie Petrone, SCRS Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00014638     History of Changes
Other Study ID Numbers: CDR0000068583, NOVARTIS-CFEM345A-US10
Study First Received: April 10, 2001
Last Updated: February 20, 2013
Health Authority: United States: Federal Government

Keywords provided by Novartis:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014