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

February 28, 2017 updated by: Novartis

Randomized Multi-Center Study Comparing Prolonged Primary Systemic Endocrine Therapy With Letrozole Alone or in Combination With Zoledronic Acid in Early Breast Cancer (NEOadjuvant Study in CANada)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

190

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
        • Novartis Investigative Site
    • Alberta
      • Edmonton, Alberta, Canada
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Novartis Investigative Site
      • Victoria, British Columbia, Canada
        • Novartis Investigative Site
    • Ontario
      • London, Ontario, Canada
        • Novartis Investigative Site
      • Toronto, Ontario, Canada
        • Novartis Investigative Site
      • Windsor, Ontario, Canada
        • Novartis Investigative Site
    • Quebec
      • Granby, Quebec, Canada
        • Novartis Investigative Site
      • Montreal, Quebec, Canada
        • Novartis Investigative Site
      • Victoriaville, Quebec, Canada
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

  • Postmenopausal women
  • Newly diagnosed with non metastatic breast cancer
  • Candidate for mastectomy or breast-conserving surgery

Exclusion Criteria

  • Patients with invasive tumors
  • Patients receiving anti-cancer treatment
  • Patients who have undergone surgery

Other protocol-defined exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Clinical response at 24 weeks

Secondary Outcome Measures

Outcome Measure
Biomarkers
Clinical response at 16 weeks
Clinical benefit at 16 weeks
Clinical benefit at 24 weeks
Rate of breast conserving surgery in both arms
Rate of complete pathological response

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

November 1, 2005

First Submitted That Met QC Criteria

November 1, 2005

First Posted (Estimate)

November 2, 2005

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446GCA08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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