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

Phase 2

Completed

• Conditions: Postmenopausal Women With Advanced Breast Cancer
• Interventions: Drug: Letrozole

• Registration Number: NCT00247663
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

- 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-12
• Study First Submitted: 2005-11-01
• Study First Submitted QC: 2005-11-01
• Study First Posted: 2005-11-02
• Primary Completion: 2005-12
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-18
• Last Update Posted: 2012-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Letrozole	Letrozole	-

Primary Outcome Measures

Name	Time	Method
Safety during treatment

Secondary Outcome Measures

Name	Time	Method
No secondary outcomes/objectives planned

Trial Locations

Locations (1)

Novartis Investigative Site; 🇯🇵 Saitama, Japan