Phase 4
Completed N=114
Arthralgia During Anastrozole Therapy for Breast Cancer
Source: ClinicalTrials.gov NCT00323479 ↗Enrolled (actual)
114
Serious AEs
5.5%
Results posted
Apr 2012
Primary outcomePrimary: Number of Participants With New Events of Arthralgia — 37 Participants
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.
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 | — |
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
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. Informational only — not medical advice.