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

- 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.

Completed

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Key information

Conditions

Postmenopausal Women With Advanced Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Kashiwa, Chiba, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

letrozole

Drug

Other names: FEM345

Primary outcomes

Safety during treatment

Secondary outcomes

No secondary outcomes/objectives planned

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Collaborators

Chugai Pharmaceutical

Registry information

Important dates

Study start: 1999
Primary completion: 2005
First posted: Nov 2, 2005
Registry last updated: Apr 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed