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

February 21, 2017 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

655

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Albstadt, Germany
        • Novartis Investigative Site
      • Augsburg, Germany
        • Schorndorf
      • 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
        • Novartis Investigative Site
      • Konstanz, Germany
        • Schorndorf
      • 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, Germany
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Letrozole
Drug: Letrozole
2.5 mg/day - oraly
Other Names:
  • Femara
  • FEM345

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

May 31, 2006

First Submitted That Met QC Criteria

June 1, 2006

First Posted (Estimate)

June 2, 2006

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFEM345DDE10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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