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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00329940
First received: May 23, 2006
Last updated: August 6, 2012
Last verified: August 2012
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the causes of discontinuation [ Time Frame: at 1, 3 and 6 months of letrozole treatment ] [ Designated as safety issue: No ]
  • To determine how long letrozole treatment is maintained [ Time Frame: at 1, 3 and 6 months of letrozole treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329940

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00329940     History of Changes
Other Study ID Numbers: CFEM345DFR04
Study First Received: May 23, 2006
Last Updated: August 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014