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Arthralgia During Anastrozole Therapy for Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00323479
First received: May 8, 2006
Last updated: March 13, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to describe the joint symptoms and structural joint changes under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer.


Condition Intervention Phase
Early Breast Cancer
 Drug: Anastrozole
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicentre, Open Study Assessing Joint Disorders Under ARIMIDEX® (1mg/Day) as Adjuvant Treatment in Post Menopausal Women With Early Breast Cancer

Resource links provided by NLM:

Drug Information available for: Anastrozole
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of Participants With New Events of Arthralgia [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional Index of Cochin at 12 Months in Patients Under Anastrozole. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Functional index of cochin score (from 0 to 90) : sum up of 18 questions on activities involving hands (each question scored from 0 = yes without difficulties (best) to 5 = impossible (worst)) based on 99 patients due to missing values.

  • Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Results are based on 97 patients due to missing values

  • Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    X ray evaluation of arthritis in 30 articulations ; each articulation scored from (0 = no arthritis to 4 = severe arthritis) based on 92 patients due to missing values

  • Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    X ray assessment on hands and wrists based on 99 patients due to missing values

  • Percentage of Participant With Therapeutic Maintenance Under Anastrozole [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Treatment compliance. results based on 109 patients due to missing values


Enrollment: 114
Study Start Date: June 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Anastrozole
    1mg/Day oral
    Other Names:
    • ARIMIDEX
    • ZD1033
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00323479

Locations
France
Research Site
Bordeaux, France
Research Site
Caen, France
Research Site
Lyon, France
Research Site
Paris, France
Research Site
Poitiers, France
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca France Medical Director, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00323479     History of Changes
Other Study ID Numbers: D5392L00013, 2005-00-5441-19 EUDRACT number
Study First Received: May 8, 2006
Results First Received: January 26, 2010
Last Updated: March 13, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AstraZeneca:
breast cancer treatment
joint disorders

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013