Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Letrozole

• Registration Number: NCT00332852
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This is a prospective open-label one-arm phase III trial designed to evaluate the safety and efficacy of letrozole 2.5 mg administered orally daily for 24 months as adjuvant therapy in postmenopausal patients with primary breast cancer.

This trial is not recruiting patients in the United States.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-05-31
• Study First Submitted QC: 2006-06-01
• Study First Posted: 2006-06-02
• Primary Completion: 2010-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-21
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 655

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Letrozole	Letrozole	-

Primary Outcome Measures

Name	Time	Method
Rate of patients without recurrence after 24 months of Letrozole treatment as assessed by radiological imaging	after 24 months

Secondary Outcome Measures

Name	Time	Method
Quality of life as assessed by EORTC QLQ-C30 + BR23 every 3 months	Every 6 months
Disease free survival (DFS)	every 6 months for 24 months
Safety and tolerability with assessments incuding biochemistry, hematology, ECG, pyhsical exam and AE documentation	every 6 months

Trial Locations

Locations (3)

Novartis Investigative Site; 🇩🇪 Wolfsburg, Germany

Schorndorf; 🇩🇪 Konstanz, Germany

Novartis Investigative site; 🇩🇪 Celle, Germany