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

This study has been completed.

First Received: November 1, 2005 Last Updated: September 6, 2007 History of Changes

Sponsors and Collaborators:	Novartis Chugai Pharmaceutical
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00247663

Purpose

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.

Condition	Intervention	Phase
Postmenopausal Women With Advanced Breast Cancer	Drug: Letrozole	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Extension Study of 1.0mg Dose Letrozole Therapy in Postmenopausal Patients With Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Letrozole

Further study details as provided by Novartis:

Primary Outcome Measures:

Secondary Outcome Measures:

Estimated Enrollment:	30
Study Start Date:	December 1999

Eligibility

Criteria

Inclusion Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247663

Sponsors and Collaborators

Novartis

Chugai Pharmaceutical

Investigators

Study Chair:

Novartis

More Information

No publications provided

Study ID Numbers:	CFEM345 1601
Study First Received:	November 1, 2005
Last Updated:	September 6, 2007
ClinicalTrials.gov Identifier:	NCT00247663 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Aromatase inhibitor
letrozole
breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Letrozole
Aromatase Inhibitors
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Breast Neoplasms
Enzyme Inhibitors
Letrozole
Aromatase Inhibitors
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009