Trial Outcomes & Findings for Arthralgia During Anastrozole Therapy for Breast Cancer (NCT NCT00323479)

NCT ID: NCT00323479

Last Updated: 2012-04-06

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 114 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2012-04-06

Participant Flow

Patients were included by an investigator-oncologist between 15 June 2006 and 31 December 2007

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)

Participant milestones

Measure	Anastrozole 1 mg Anastrozole 1 mg once daily
Overall Study STARTED	114
Overall Study Safety Population	110
Overall Study COMPLETED	106
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Anastrozole 1 mg Anastrozole 1 mg once daily
Overall Study Adverse Event	2
Overall Study Withdrawal by Subject	2
Overall Study Protocol Violation	3
Overall Study house moving	1

Baseline Characteristics

Arthralgia During Anastrozole Therapy for Breast Cancer

Baseline characteristics by cohort

Measure	Anastrozole 1 mg n=106 Participants Anastrozole 1 mg once daily
Age Continuous	62.87 year STANDARD_DEVIATION 6.87 • n=5 Participants
Sex: Female, Male Female	106 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Measure	Anastrozole 1 mg n=106 Participants Anastrozole 1 mg once daily
Number of Participants With New Events of Arthralgia	37 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Anastrozole 1 mg n=99 Participants Anastrozole 1 mg once daily
Functional Index of Cochin at 12 Months in Patients Under Anastrozole.	4.32 Units on scale Standard Deviation 9.46

SECONDARY outcome

Timeframe: 12 months

Results are based on 97 patients due to missing values

Outcome measures

Measure	Anastrozole 1 mg n=97 Participants Anastrozole 1 mg once daily
Serum Collagen Degradation Type I - CTX-I at 12 Months in Patients Under Anastrozole	0.5 Ng/mL Standard Deviation 0.28

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Anastrozole 1 mg n=92 Participants Anastrozole 1 mg once daily
Kellgren and Lawrence Score at 12 Months in Patients Under Anastrozole	12.66 Units on scale Standard Deviation 13.64

SECONDARY outcome

Timeframe: 12 months

X ray assessment on hands and wrists based on 99 patients due to missing values

Outcome measures

Measure	Anastrozole 1 mg n=99 Participants Anastrozole 1 mg once daily
Synovial Membrane Thickness at 12 Months in Patients Under Anastrozole	1.77 millimeter Standard Deviation 0.62

SECONDARY outcome

Timeframe: 12 months

Treatment compliance. results based on 109 patients due to missing values

Outcome measures

Measure	Anastrozole 1 mg n=109 Participants Anastrozole 1 mg once daily
Percentage of Participant With Therapeutic Maintenance Under Anastrozole	80.7 percentage of participants

Adverse Events

Anastrozole 1 mg

Serious events: 6 serious events

Other events: 106 other events

Deaths: 0 deaths

Serious adverse events

Measure	Anastrozole 1 mg n=110 participants at risk Anastrozole 1 mg once daily
General disorders Sudden death unexplained	0.91% 1/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Infections and infestations Lymphangitis	0.91% 1/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Respiratory, thoracic and mediastinal disorders Pneumopathy	0.91% 1/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Renal and urinary disorders Calculus urinary bladder	0.91% 1/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Psychiatric disorders Depression worsened	0.91% 1/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
General disorders General body pain	0.91% 1/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid adenoma	0.91% 1/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Injury, poisoning and procedural complications Femur fracture	0.91% 1/110 110 participants were included in the safety population, those who had taken at least one dose of treatment

Other adverse events

Measure	Anastrozole 1 mg n=110 participants at risk Anastrozole 1 mg once daily
Musculoskeletal and connective tissue disorders arthralgia	53.6% 59/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Vascular disorders hot flush	31.8% 35/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Musculoskeletal and connective tissue disorders pain in extremity	28.2% 31/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
General disorders asthenia	15.5% 17/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Musculoskeletal and connective tissue disorders back pain	12.7% 14/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Psychiatric disorders insomnia	10.9% 12/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Nervous system disorders headache	10.0% 11/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Ear and labyrinth disorders vertigo	7.3% 8/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Gastrointestinal disorders abdominal pain upper	5.5% 6/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Gastrointestinal disorders nausea	9.1% 10/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
General disorders fatigue	9.1% 10/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Musculoskeletal and connective tissue disorders musculoskeletal chest pain	6.4% 7/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Musculoskeletal and connective tissue disorders musculosketal pain	8.2% 9/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Musculoskeletal and connective tissue disorders neck pain	5.5% 6/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Reproductive system and breast disorders breast fibrosis	6.4% 7/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Reproductive system and breast disorders breast oedema	7.3% 8/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Reproductive system and breast disorders breast pain	7.3% 8/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Skin and subcutaneous tissue disorders erythema	6.4% 7/110 110 participants were included in the safety population, those who had taken at least one dose of treatment
Vascular disorders lymphoedema	5.5% 6/110 110 participants were included in the safety population, those who had taken at least one dose of treatment

Additional Information

Gerard Lynch

AstraZeneca

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60