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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00247650
First received: November 1, 2005
Last updated: November 20, 2009
Last verified: November 2009

November 1, 2005
November 20, 2009
September 2005
March 2007   (final data collection date for primary outcome measure)
Clinical response at 24 weeks
Not Provided
Complete list of historical versions of study NCT00247650 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Comparison Study of Letrozole Alone or Letrozole With Zoledronic Acid in Early Breast Cancer, Neoadjuvant Therapy
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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: Zoledronic Acid; Letrozole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
Not Provided
March 2007   (final data collection date for primary outcome measure)

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.

Female
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00247650
CZOL446GCA08
Not Provided
External Affairs, Novartis
Novartis
Not Provided
Study Chair: Novartis Novartis
Novartis
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP