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


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

at 1, 3 and 6 months of letrozole treatment

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CFEM345DFR04

NCT ID:

NCT00329940

Start Date:

November 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • Letrozole
  • breast cancer
  • critical musculoskeletal
  • postmenopausal
  • rheumatologic tolerance
  • Breast Neoplasms
  • Musculoskeletal Diseases

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