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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
An Open Phase III Trial With Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Letrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Letrozole<br> | Drug: Letrozole<br>* 2.5 mg/day - oraly<br>* Other names: FEM345;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients without recurrence after 24 months of Letrozole treatment as assessed by radiological imaging |  | after 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival (DFS) |  | every 6 months for 24 months | 
| Quality of life as assessed by EORTC QLQ-C30 + BR23 every 3 months |  | Every 6 months | 
| Safety and tolerability with assessments incuding biochemistry, hematology, ECG, pyhsical exam and AE documentation |  | every 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postive breast cancer, postmenopausal, disease free survival, letrozole, early adjuvant treatment, primary hormone receptor