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Safety and Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00329940
First Posted: May 25, 2006
Last Update Posted: February 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
The purpose of this study is to assess rheumatologic tolerability of letrozole in postmenopausal patients with hormone receptor positive breast cancer having discontinued anastrozole adjuvant treatment due to musculoskeletal disorders.

Condition Intervention Phase
Breast Cancer Drug: Letrozole Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer Having Discontinued Anastrozole Adjuvant Treatment Due to Musculoskeletal Disorders

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • To evaluate the rheumatological tolerability of letrozole 2.5 mg/day in patients treated with anastrozole 1 mg/day [ Time Frame: at 1, 3 and 6 months of letrozole treatment ]

Secondary Outcome Measures:
  • To determine the causes of discontinuation [ Time Frame: at 1, 3 and 6 months of letrozole treatment ]
  • To determine how long letrozole treatment is maintained [ Time Frame: at 1, 3 and 6 months of letrozole treatment ]

Enrollment: 200
Study Start Date: November 2005
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Letrozole
to evaluate the rheumatological tolerability of Femara
Drug: Letrozole
Other Name: Femara

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Postmenopausal women receiving anastrozole adjuvant therapy for hormone receptor positive breast cancer who want to interrupt the treatment because of severe rheumatologic adverse events
  • Polymorphonuclear neutrophils (PNN) ≥ 1200/mm3, platelets ≥ 100000/mm3, hemoglobin (Hb) ≥ 10 g/dL
  • Bilirubin ≤ 30 μmol, SGOT/SGPT < 3N
  • Fully signed informed consent

Exclusion Criteria:

  • Pain due to bone fracture
  • Metastatic disease
  • Hormone therapy other than anastrozole
  • Incapacitating or uncontrolled concomitant disease that could hamper patient's quality of life
  • Hypersensitivity to letrozole or its components

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329940


Locations
France
Novartis Investigative Site
Saint Cloud, France
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00329940     History of Changes
Other Study ID Numbers: CFEM345DFR04
First Submitted: May 23, 2006
First Posted: May 25, 2006
Last Update Posted: February 24, 2017
Last Verified: February 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Letrozole
breast cancer
critical musculoskeletal
postmenopausal
rheumatologic tolerance

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Letrozole
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists