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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00332852
First received: May 31, 2006
Last updated: July 7, 2011
Last verified: July 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer
 Drug: Letrozole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Phase III Trial With Letrozole as Early Adjuvant Treatment of Postmenopausal Patients With Primary Breast Cancer

Resource links provided by NLM:

Drug Information available for: Letrozole
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Rate of patients without recurrence after 24 months of Letrozole treatment as assessed by radiological imaging [ Time Frame: after 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease free survival (DFS) [ Time Frame: every 6 months for 24 months ] [ Designated as safety issue: No ]
  • Quality of life as assessed by EORTC QLQ-C30 + BR23 every 3 months [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
  • Safety and tolerability with assessments incuding biochemistry, hematology, ECG, pyhsical exam and AE documentation [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 655
Study Start Date: March 2006
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Letrozole Drug: Letrozole
2.5 mg/day - oraly
Other Names:
  • Femara
  • FEM345

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332852

  Show 54 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmeceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00332852     History of Changes
Other Study ID Numbers: CFEM345DDE10
Study First Received: May 31, 2006
Last Updated: July 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Postive breast cancer
postmenopausal
disease free survival
 letrozole
early adjuvant treatment
primary hormone receptor

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Letrozole
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013