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NCT00247650 Clinical Trial

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

Breast Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00247650
Other study ID # CZOL446GCA08
Secondary ID
Status Completed
Phase Phase 2
First received November 1, 2005
Last updated February 28, 2017
Start date September 2005

Study information
Verified date November 2009
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 190
Est. completion date
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Female
Age group 65 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Zoledronic Acid; Letrozole

Locations
Country Name City State
Canada Novartis Investigative Site Edmonton Alberta
Canada Novartis Investigative Site Granby Quebec
Canada Novartis Investigative Site London Ontario
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Quebec
Canada Novartis Investigative Site Toronto Ontario
Canada Novartis Investigative Site Vancouver British Columbia
Canada Novartis Investigative Site Victoria British Columbia
Canada Novartis Investigative Site Victoriaville Quebec
Canada Novartis Investigative Site Windsor Ontario

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical response at 24 weeks
Secondary Clinical response at 16 weeks
Secondary Clinical benefit at 16 weeks
Secondary Clinical benefit at 24 weeks
Secondary Rate of breast conserving surgery in both arms
Secondary Rate of complete pathological response
Secondary Biomarkers
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