Comparison Study of Letrozole Alone or Letrozole With Zoledronic Acid in Early Breast Cancer, Neoadjuvant Therapy
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...
Brief Summary
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)”
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 Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: March 2007
Intervention(s) in this Clinical Trial
- Drug: Zoledronic Acid; Letrozole
Outcome Measures for this Clinical Trial
Primary Measures
- Clinical response at 24 weeks
Secondary 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
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 65 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Study Chair Novartis
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00247650
Study ID Number: CZOL446GCA08
ClinicalTrials.gov Identifier: NCT00247650
Health Authority: Canada: Health Canada
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00247650
