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

NCT00332852 | Completed Phase 3

• 1 other identifier: CFEM345DDE10
• Study Type: interventional
• Target: 655
• Locations: 1 country
• Sites: 53

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of patients without recurrence after 24 months of Letrozole treatment as assessed by radiological imaging

  after 24 months

Secondary Outcomes (3)

• 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

Study Arms (1)

Letrozole

EXPERIMENTAL

Drug: Letrozole

Interventions

Letrozole DRUG

2.5 mg/day - oraly

Also known as: Femara, FEM345

Letrozole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (53)

Novartis Investigative Site

Albstadt, Germany

Location

Schorndorf

Augsburg, Germany

Location

Novartis Investigative Site

Bamberg, Germany

Location

Novartis Investigative Site

Berlin, Germany

Location

Novartis Investigative Site

Bonn, Germany

Location

Novartis Investigative Site

Bottrop, Germany

Location

Novartis Investigative Site

Braunschweig, Germany

Location

Novartis Investigative site

Celle, Germany

Location

Novartis Investigative Site

Chemnitz, Germany

Location

Novartis Investigative Site

Dortmund, Germany

Location

Novartis Investigative Site

Frankfurt, Germany

Location

Novartis Investigative Site

Fulda, Germany

Location

Novartis Investigative Site

Gera, Germany

Location

Novartis Investigative Site

Gütersloh, Germany

Location

Novartis Investigative Site

Hamburg, Germany

Location

Novartis Investigative Site

Hamelin, Germany

Location

Novartis Investigative Site

Hanover, Germany

Location

Novartis Investigative Site

Herne, Germany

Location

Novartis Investigative Site

Holzminden, Germany

Location

Novartis Investigative Site

Höxter, Germany

Location

Novartis Investigative Site

Ilsede, Germany

Location

Novartis Investigative Site

Itzehoe, Germany

Location

Novartis Investigative Site

Jena, Germany

Location

Novartis Investigative Site

Karlsruhe, Germany

Location

Novartis Investigative Site

Kempten, Germany

Location

Novartis Investigative Site

Konigs, Germany

Location

Schorndorf

Konstanz, Germany

Location

Novartis Investigative Site

Lich, Germany

Location

Novartis Investigative Site

Lohsa/Weisskollm, Germany

Location

Novartis Investigative Site

Ludwigsburg, Germany

Location

Novartis Investigative Site

Memmingen, Germany

Location

Novartis Investigative Site

Mühlhausen, Germany

Location

Novartis Investigative Site

München, Germany

Location

Novartis Investigative Site

Münster, Germany

Location

Novartis Investigative Site

Neumünster, Germany

Location

Novartis Investigative Site

Neunkirchen, Germany

Location

Novartis Investigative Site

Offenburg, Germany

Location

Novartis Investigative Site

Pforzheim, Germany

Location

Novartis Investigative Site

Rendsburg, Germany

Location

Novartis Investigative Site

Saarbrücken, Germany

Location

Novartis Investigative Site

Saarlouis, Germany

Location

Novartis Investigative Site

Saint Wendel, Germany

Location

Novartis Investigative Site

Salzgitter, Germany

Location

Novartis Investigative Site

Schorndorf, Germany

Location

Novartis Investigative Site

Schwetzingen, Germany

Location

Novartis Investigative Site

Starnberg, Germany

Location

Novartis Investigative Site

Stuttgart, Germany

Location

Novartis Investigative Site

Tuttlingen, Germany

Location

Novartis Investigative Site

Ulm, Germany

Location

Novartis Investigative Site

Walsrode, Germany

Location

Novartis Investigative Site

Westerburg, Germany

Location

Novartis Investigative Site

Wiesbaden, Germany

Location

Novartis Investigative Site

Wolfsburg, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmeceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 31, 2006
• First Posted: June 2, 2006
• Study Start: March 1, 2006
• Primary Completion: July 1, 2010
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

DE (53)