Early Breast Cancer
Conditions
Keywords
breast cancer treatment, joint disorders
Brief 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.
Interventions
DRUGAnastrozole
1mg/Day oral
Sponsors
AstraZeneca
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With New Events of Arthralgia | 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Index of Cochin at 12 Months in Patients Under Anastrozole. | 12 months | 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 | 12 months | Results are based on 97 patients due to missing values |
| Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole | 12 months | 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 | 12 months | X ray assessment on hands and wrists based on 99 patients due to missing values |
| Percentage of Participant With Therapeutic Maintenance Under Anastrozole | 12 months | Treatment compliance. results based on 109 patients due to missing values |
Countries
France
Participant flow
Recruitment details
Patients were included by an investigator-oncologist between 15 June 2006 and 31 December 2007
Pre-assignment details
Patients were included by an investigator-oncologist who followed them up every 3 months over a period of one year (i.e., 5 visits). An investigator rheumatologist carried out the rheumatological evaluations at inclusion and then every 6 months over a period of one year (i.e., 3 visits)
Participants by arm
| Arm | Count |
|---|---|
| Anastrozole 1 mg Anastrozole 1 mg once daily | 106 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | house moving | 1 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Anastrozole 1 mg |
|---|---|
| Age Continuous | 62.87 year STANDARD_DEVIATION 6.87 |
| Sex: Female, Male Female | 106 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 106 / 110 |
| serious Total, serious adverse events | 6 / 110 |
Outcome results
Primary
Number of Participants With New Events of Arthralgia
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anastrozole 1 mg | Number of Participants With New Events of Arthralgia | 37 Participants |
Secondary
Functional Index of Cochin at 12 Months in Patients Under Anastrozole.
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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anastrozole 1 mg | Functional Index of Cochin at 12 Months in Patients Under Anastrozole. | 4.32 Units on scale | Standard Deviation 9.46 |
Secondary
Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole
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
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anastrozole 1 mg | Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole | 12.66 Units on scale | Standard Deviation 13.64 |
Secondary
Percentage of Participant With Therapeutic Maintenance Under Anastrozole
Treatment compliance. results based on 109 patients due to missing values
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anastrozole 1 mg | Percentage of Participant With Therapeutic Maintenance Under Anastrozole | 80.7 percentage of participants |
Secondary
Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole
Results are based on 97 patients due to missing values
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Anastrozole 1 mg | Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole | 0.5 Ng/mL | Standard Deviation 0.28 |
Secondary
Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole
X ray assessment on hands and wrists based on 99 patients due to missing values
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Anastrozole 1 mg | Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole | 1.77 millimeter | Standard Deviation 0.62 |