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

Assessment of Rheumatologic Tolerability of Letrozole in Postmenopausal Patients With Hormone Receptor Positive Breast Cancer Having Discontinued Anastrozole Adjuvant Treatment Due to Musculoskeletal Disorders

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00329940

Enrollment

200

Registered

2006-05-25

Start date

2005-11-30

Completion date

Unknown

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Letrozole, breast cancer, critical musculoskeletal, postmenopausal, rheumatologic tolerance

Brief 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.

Interventions

DRUGLetrozole

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
To evaluate the rheumatological tolerability of letrozole 2.5 mg/day in patients treated with anastrozole 1 mg/day	at 1, 3 and 6 months of letrozole treatment

Secondary

Measure	Time frame
To determine the causes of discontinuation	at 1, 3 and 6 months of letrozole treatment
To determine how long letrozole treatment is maintained	at 1, 3 and 6 months of letrozole treatment

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026