Letrozole in Treating Postmenopausal Women With Metastatic Breast Cancer

February 20, 2013 updated by: Novartis

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Chair: Stephanie Petrone, SCRS, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

March 1, 2002

Study Completion (Actual)

March 1, 2002

Study Registration Dates

First Submitted

April 10, 2001

First Submitted That Met QC Criteria

November 12, 2003

First Posted (Estimate)

November 13, 2003

Study Record Updates

Last Update Posted (Estimate)

February 21, 2013

Last Update Submitted That Met QC Criteria

February 20, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068583
  • NOVARTIS-CFEM345A-US10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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