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)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00247650

Enrollment

190

Registered

2005-11-02

Start date

2005-09-30

Completion date

Unknown

Last updated

2017-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

neoadjuvant, postmenopausal women, breast cancer, hormonal therapy, bisphosphonate

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

Interventions

DRUGZoledronic Acid; Letrozole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Clinical response at 24 weeks	—

Secondary

Measure	Time frame
Clinical benefit at 16 weeks	—
Clinical benefit at 24 weeks	—
Clinical response at 16 weeks	—
Rate of complete pathological response	—
Biomarkers	—
Rate of breast conserving surgery in both arms	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026