Safety and Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00329940

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 III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole Letrozole

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

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: every month for 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the causes of discontinuation [ Designated as safety issue: No ]
To determine how long letrozole treatment is maintained [ 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
1: Experimental to evaluate the rheumatological tolerability of Femara	Drug: Letrozole

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

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

Locations

France
Novartis Investigative Site
Saint Cloud, France

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CFEM345DFR04
Study First Received:	May 23, 2006
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00329940
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Novartis:

Letrozole
breast cancer
critical musculoskeletal issues

postmenopausal
rheumatologic tolerance
postmenopausal woman with breast cancer associated with critical musculoskeletal issues

Study placed in the following topic categories:

Anastrozole
Skin Diseases
Musculoskeletal Diseases

Breast Neoplasms
Letrozole
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009