Phase 4 N=114 Treatment

Arthralgia During Anastrozole Therapy for Breast Cancer

Early Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00323479 ↗

Enrolled (actual)

114

Serious AEs

5.5%

Results posted

Apr 2012

Primary outcome: Primary: Number of Participants With New Events of Arthralgia — 37 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Anastrozole (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: AstraZeneca
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With New Events of Arthralgia	37	—
SECONDARY Functional Index of Cochin at 12 Months in Patients Under Anastrozole.	4.32	—
SECONDARY Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole	0.5	—
SECONDARY Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole	12.66	—
SECONDARY Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole	1.77	—
SECONDARY Percentage of Participant With Therapeutic Maintenance Under Anastrozole	80.7	—

Summary

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00323479). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.