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)
1 other identifier
interventional
190
1 country
10
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 1, 2005
CompletedFirst Posted
Study publicly available on registry
November 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedMarch 1, 2017
November 1, 2009
1.5 years
November 1, 2005
February 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical response at 24 weeks
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Postmenopausal women
- Newly diagnosed with non metastatic breast cancer
- Candidate for mastectomy or breast-conserving surgery
You may not qualify if:
- Patients with invasive tumors
- Patients receiving anti-cancer treatment
- Patients who have undergone surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (10)
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
Vancouver, British Columbia, Canada
Novartis Investigative Site
Victoria, British Columbia, Canada
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Windsor, Ontario, Canada
Novartis Investigative Site
Granby, Quebec, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Québec, Quebec, Canada
Novartis Investigative Site
Victoriaville, Quebec, Canada
Related Publications (1)
Adams A, Jakob T, Huth A, Monsef I, Ernst M, Kopp M, Caro-Valenzuela J, Wockel A, Skoetz N. Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis. Cochrane Database Syst Rev. 2024 Jul 9;7(7):CD013451. doi: 10.1002/14651858.CD013451.pub2.
PMID: 38979716DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Novartis
Novartis
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 1, 2005
First Posted
November 2, 2005
Study Start
September 1, 2005
Primary Completion
March 1, 2007
Last Updated
March 1, 2017
Record last verified: 2009-11