Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

Novartis

Status and phase

Completed

Phase 3

Conditions

Breast Cancer

Treatments

Drug: Letrozole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00332852

CFEM345DDE10

Details and patient eligibility

About

This is a prospective open-label one-arm phase III trial designed to evaluate the safety and efficacy of letrozole 2.5 mg administered orally daily for 24 months as adjuvant therapy in postmenopausal patients with primary breast cancer.

This trial is not recruiting patients in the United States.

Enrollment

655 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Compliant postmenopausal women with primary operable breast cancer after complete surgery and suitable for endocrine treatment
Nodal status negative or positive
Good Health status 0-2 (Eastern Cooperative Oncology Group)
Estrogen- and/or progesterone-receptor positive
Adequate marrow, kidney and liver function

Exclusion criteria

Metastatic or inflammatory breast cancer
Patients with previous or concomitant cancers (not breast cancer) within the past 5 years EXCEPT adequately treated basal or squamous cell skin cancer or in situ cancer of the cervix. Patients with other previous cancers must have been disease-free for at least 5 years and Patients with uncontrolled, non-malignant systemic cardiovascular, kidney, and liver diseases.
Current/active dental problems including infection of the teeth or jawbone, dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw, of exposed bone in the mouth, or of slow healing after dental procedures.
Recent (within 6 weeks) or planned dental or jaw surgery
Patients with primary overactive parathyroid
Patients with a known hypersensitivity to zoledronic acid or other bisphosphonates.