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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00247650
First Posted: November 2, 2005
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Novartis
  Purpose
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

Condition Intervention Phase
Breast Cancer Drug: Zoledronic Acid; Letrozole Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Clinical response at 24 weeks

Secondary Outcome Measures:
  • 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
  • Biomarkers

Estimated Enrollment: 190
Study Start Date: September 2005
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00247650


Locations
Canada, Alberta
Novartis Investigative Site
Edmonton, Alberta, Canada
Canada, British Columbia
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Victoria, British Columbia, Canada
Canada, Ontario
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Windsor, Ontario, Canada
Canada, Quebec
Novartis Investigative Site
Granby, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Victoriaville, Quebec, Canada
Canada
Novartis Investigative Site
Quebec, Canada
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

Additional Information:
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00247650     History of Changes
Other Study ID Numbers: CZOL446GCA08
First Submitted: November 1, 2005
First Posted: November 2, 2005
Last Update Posted: March 1, 2017
Last Verified: November 2009

Keywords provided by Novartis:
neoadjuvant, postmenopausal women, breast cancer, hormonal therapy, bisphosphonate

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Zoledronic acid
Diphosphonates
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents