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

Information source: Novartis
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Letrozole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis Pharmaceuticals

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Director, Affiliation: Novartis Pharmaceuticals

Summary

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.

Clinical Details

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

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To evaluate the rheumatological tolerability of letrozole 2.5 mg/day in patients treated with anastrozole 1 mg/day

Secondary outcome:

To determine the causes of discontinuation

To determine how long letrozole treatment is maintained

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

Novartis Investigative Site, Saint Cloud, France
Additional Information

Starting date: November 2005
Last updated: August 6, 2012

Page last updated: August 20, 2015

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