Clinical trial NCT00332852: Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
Official title: An Open Phase III Trial With Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Postive breast cancer
postmenopausal
disease free survival
letrozole
early adjuvant treatment
primary hormone receptor
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-06-02
Enrollment: 655
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Rate of patients without recurrence after 24 months of Letrozole treatment as assessed by radiological imaging
timeFrame: after 24 months
Secondary outcomes:
measure: Disease free survival (DFS)
timeFrame: every 6 months for 24 months
measure: Quality of life as assessed by EORTC QLQ-C30 + BR23 every 3 months
timeFrame: Every 6 months
measure: Safety and tolerability with assessments incuding biochemistry, hematology, ECG, pyhsical exam and AE documentation
timeFrame: every 6 months
Other outcomes:
Locations:
city: Albstadt
country: Germany
facility: Novartis Investigative Site
city: Augsburg
country: Germany
facility: Schorndorf
city: Bamberg
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Bottrop
country: Germany
facility: Novartis Investigative Site
city: Braunschweig
country: Germany
facility: Novartis Investigative Site
city: Celle
country: Germany
facility: Novartis Investigative site
city: Chemnitz
country: Germany
facility: Novartis Investigative Site
city: Dortmund
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Fulda
country: Germany
facility: Novartis Investigative Site
city: Gera
country: Germany
facility: Novartis Investigative Site
city: Gütersloh
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hameln
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Herne
country: Germany
facility: Novartis Investigative Site
city: Holzminden
country: Germany
facility: Novartis Investigative Site
city: Hoxter
country: Germany
facility: Novartis Investigative Site
city: Ilsede
country: Germany
facility: Novartis Investigative Site
city: Itzehoe
country: Germany
facility: Novartis Investigative Site
city: Jena
country: Germany
facility: Novartis Investigative Site
city: Karlsruhe
country: Germany
facility: Novartis Investigative Site
city: Kempten
country: Germany
facility: Novartis Investigative Site
city: Konigs
country: Germany
facility: Novartis Investigative Site
city: Konstanz
country: Germany
facility: Schorndorf
city: Lich
country: Germany
facility: Novartis Investigative Site
city: Lohsa/Weisskollm
country: Germany
facility: Novartis Investigative Site
city: Ludwigsburg
country: Germany
facility: Novartis Investigative Site
city: Memmingen
country: Germany
facility: Novartis Investigative Site
city: Muhlhausen
country: Germany
facility: Novartis Investigative Site
city: Munchen
country: Germany
facility: Novartis Investigative Site
city: Munster
country: Germany
facility: Novartis Investigative Site
city: Neumunster
country: Germany
facility: Novartis Investigative Site
city: Neunkirchen
country: Germany
facility: Novartis Investigative Site
city: Offenburg
country: Germany
facility: Novartis Investigative Site
city: Pforzheim
country: Germany
facility: Novartis Investigative Site
city: Rendsburg
country: Germany
facility: Novartis Investigative Site
city: Saarbrucken
country: Germany
facility: Novartis Investigative Site
city: Saarbrücken
country: Germany
facility: Novartis Investigative Site
city: Saarlouis
country: Germany
facility: Novartis Investigative Site
city: Salzgitter
country: Germany
facility: Novartis Investigative Site
city: Schorndorf
country: Germany
facility: Novartis Investigative Site
city: Schwetzingen
country: Germany
facility: Novartis Investigative Site
city: St. Wendel
country: Germany
facility: Novartis Investigative Site
city: Starnberg
country: Germany
facility: Novartis Investigative Site
city: Stuttgart
country: Germany
facility: Novartis Investigative Site
city: Tuttlingen
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Walsrode
country: Germany
facility: Novartis Investigative Site
city: Westerburg
country: Germany
facility: Novartis Investigative Site
city: Wiesbaden
country: Germany
facility: Novartis Investigative Site
city: Wolfsburg
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmeceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: