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

Novartis

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Zoledronic Acid; Letrozole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00247650

CZOL446GCA08

Details and patient eligibility

About

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

Enrollment: 190 estimated patients

Sex: Female

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)