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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: May 23, 2006
Last updated: February 22, 2017
Last verified: February 2017
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: No masking
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 ]

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


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

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
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Please refer to this study by its identifier: NCT00329940

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

Additional Information:
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00329940     History of Changes
Other Study ID Numbers: CFEM345DFR04
Study First Received: May 23, 2006
Last Updated: February 22, 2017

Keywords provided by Novartis:
breast cancer
critical musculoskeletal
rheumatologic tolerance

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
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 processed this record on May 24, 2017