Comparison Study of Letrozole Alone or Letrozole With Zoledronic Acid in Early Breast Cancer, Neoadjuvant Therapy

Phase 2

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00247650
• Lead Sponsor: Novartis

Brief Summary

This study is to measure the extent of tumor shrinkage when Letrozole and Zoledronic Acid are given before surgery to newly diagnosed post-menopausal women with early breast cancer

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-11-01
• Study First Submitted QC: 2005-11-01
• Study First Posted: 2005-11-02
• Primary Completion: 2007-03
• Status Verified: 2009-11
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 190

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinical response at 24 weeks

Secondary Outcome Measures

Name	Time	Method
Biomarkers
Rate of complete pathological response
Clinical benefit at 16 weeks
Clinical benefit at 24 weeks
Rate of breast conserving surgery in both arms
Clinical response at 16 weeks

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇦 Quebec, Canada