Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

April 18, 2012 updated by: Novartis Pharmaceuticals
- To investigate the safety of letrozole monotherapy at a dose 1.0 mg/day or fadrozole monotherapy at a dose 2.0mg in Japanese postmenopausal patients with advanced breast cancer which participated in double blind study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

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

  • Japan
      • Fukuoka, Japan, 811-4395
        • Novartis Investigative Site
      • Kumamoto, Japan, 862-0909
        • Novartis Investigative Site
      • Nigata, Japan, 951-8566
        • Novartis Investigative Site
      • Saitama, Japan, 338-8553
        • Novartis Investigative Site
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Novartis Investigative Site
    • Hyogo
      • Amagasaki, Hyogo, Japan, 660-8511
        • Novartis Investigative Site
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 430-8558
        • Novartis Investigative Site
    • Tokyo
      • Chuo-Ku, Tokyo, Japan, 104-0045
        • Novartis Investigative Site
      • Cyuo-ku, Tokyo, Japan, 104-8560
        • Novartis Investigative Site
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Novartis Investigative Site

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

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

- Patients which participated in double blind study

Exclusion Criteria:

  • Patients with intolerable toxicity.
  • Patients which confirmed progressive disease during double blind study.
  • Patients which have received concurrent anti-cancer therapy during double blind study.

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
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Letrozole
Drug: Letrozole
Other Names:
  • FEM345

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety during treatment

Secondary Outcome Measures

Outcome Measure
No secondary outcomes/objectives planned

Collaborators and Investigators

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

Sponsor

Novartis Pharmaceuticals

Collaborators

Chugai Pharmaceutical

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

December 1, 1999

Primary Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

November 1, 2005

First Submitted That Met QC Criteria

November 1, 2005

First Posted (Estimate)

November 2, 2005

Study Record Updates

Last Update Posted (Estimate)

April 19, 2012

Last Update Submitted That Met QC Criteria

April 18, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFEM345 1601

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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