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A Multicentre, Open Study Assessing Joint Disorders Under ARIMIDEX® (1mg/Day) as Adjuvant Treatment in Post Menopausal Women With Early Breast Cancer


Phase 4
18 Years
N/A
Not Enrolling
Female
Early Breast Cancer

Thank you

Trial Information

A Multicentre, Open Study Assessing Joint Disorders Under ARIMIDEX® (1mg/Day) as Adjuvant Treatment in Post Menopausal Women With Early Breast Cancer


Inclusion Criteria:



- Post menopausal woman with a breast cancer and scheduled for an adjuvant treatment
with anastrozole

- WHO performance status 0, 1 or 2

- Provision of written informed consent

Exclusion Criteria:

- Recurrence of breast cancer, inflammatory rheumatism

- treatment by chondromodulator, oral glucocorticoid, aromatase inhibitor, anti
estrogen, Herceptin

- Diabetes treated by insulin

- Severe renal or hepatic disease

- Known hypersensitivity to anastrozole

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Number of Participants With New Events of Arthralgia

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

AstraZeneca France Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

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

Study ID:

D5392L00013

NCT ID:

NCT00323479

Start Date:

June 2006

Completion Date:

January 2009

Related Keywords:

  • Early Breast Cancer
  • breast cancer treatment
  • joint disorders
  • Breast Neoplasms

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