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

Novartis190 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

190

Conditions

Breast Cancer

Interventions

Zoledronic Acid; LetrozoleDRUG

Eligibility

Sex: FEMALEMin age: 65 Years

Medical Language ↔ Plain English

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.

Locations (10)

Novartis Investigative Site

Edmonton, Alberta, Canada

Novartis Investigative Site

Vancouver, British Columbia, Canada

Novartis Investigative Site

Victoria, British Columbia, Canada

Novartis Investigative Site

Outcomes

Primary Outcomes

Clinical response at 24 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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