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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00332852
• Other study ID #: CFEM345DDE10
• Status: Completed
• Phase: Phase 3
• First received: May 31, 2006
• Last updated: February 21, 2017
• Start date: March 2006

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 655
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Letrozole
2.5 mg/day - oraly

Locations

Country	Name	City	State
Germany	Novartis Investigative Site	Albstadt
Germany	Schorndorf	Augsburg
Germany	Novartis Investigative Site	Bamberg
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Bottrop
Germany	Novartis Investigative Site	Braunschweig
Germany	Novartis Investigative site	Celle
Germany	Novartis Investigative Site	Chemnitz
Germany	Novartis Investigative Site	Dortmund
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Fulda
Germany	Novartis Investigative Site	Gera
Germany	Novartis Investigative Site	Gütersloh
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hameln
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Herne
Germany	Novartis Investigative Site	Holzminden
Germany	Novartis Investigative Site	Hoxter
Germany	Novartis Investigative Site	Ilsede
Germany	Novartis Investigative Site	Itzehoe
Germany	Novartis Investigative Site	Jena
Germany	Novartis Investigative Site	Karlsruhe
Germany	Novartis Investigative Site	Kempten
Germany	Novartis Investigative Site	Konigs
Germany	Schorndorf	Konstanz
Germany	Novartis Investigative Site	Lich
Germany	Novartis Investigative Site	Lohsa/Weisskollm
Germany	Novartis Investigative Site	Ludwigsburg
Germany	Novartis Investigative Site	Memmingen
Germany	Novartis Investigative Site	Muhlhausen
Germany	Novartis Investigative Site	Munchen
Germany	Novartis Investigative Site	Munster
Germany	Novartis Investigative Site	Neumunster
Germany	Novartis Investigative Site	Neunkirchen
Germany	Novartis Investigative Site	Offenburg
Germany	Novartis Investigative Site	Pforzheim
Germany	Novartis Investigative Site	Rendsburg
Germany	Novartis Investigative Site	Saarbrucken
Germany	Novartis Investigative Site	Saarbrücken
Germany	Novartis Investigative Site	Saarlouis
Germany	Novartis Investigative Site	Salzgitter
Germany	Novartis Investigative Site	Schorndorf
Germany	Novartis Investigative Site	Schwetzingen
Germany	Novartis Investigative Site	St. Wendel
Germany	Novartis Investigative Site	Starnberg
Germany	Novartis Investigative Site	Stuttgart
Germany	Novartis Investigative Site	Tuttlingen
Germany	Novartis Investigative Site	Ulm
Germany	Novartis Investigative Site	Walsrode
Germany	Novartis Investigative Site	Westerburg
Germany	Novartis Investigative Site	Wiesbaden
Germany	Novartis Investigative Site	Wolfsburg

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients without recurrence after 24 months of Letrozole treatment as assessed by radiological imaging		after 24 months
Secondary	Disease free survival (DFS)		every 6 months for 24 months
Secondary	Quality of life as assessed by EORTC QLQ-C30 + BR23 every 3 months		Every 6 months
Secondary	Safety and tolerability with assessments incuding biochemistry, hematology, ECG, pyhsical exam and AE documentation		every 6 months

External Links

•   Results for CFEM345DDE10 from Novartis Clinical Trials Website