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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00332852

Enrollment

655

Registered

2006-06-02

Start date

2006-03-31

Completion date

Unknown

Last updated

2017-02-23

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

Conditions

Breast Cancer

Keywords

Postive breast cancer, postmenopausal, disease free survival, letrozole, early adjuvant treatment, primary hormone receptor

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.

Interventions

DRUGLetrozole

2.5 mg/day - oraly

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Rate of patients without recurrence after 24 months of Letrozole treatment as assessed by radiological imaging	after 24 months

Secondary

Measure	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

Countries

Germany

Outcome results

None listed

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