Trial Outcomes & Findings for Liver Safety Under Upfront Arimidex vs Tamoxifen (NCT NCT00537771)
NCT ID: NCT00537771
Last Updated: 2013-01-25
Results Overview
The primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
384 participants
Primary outcome timeframe
At 48 weeks, 96 weeks, 144 weeks
Results posted on
2013-01-25
Participant Flow
Patients were enrolled in 28 centres in the People's Republic of China. FSI: 18Sep2007; LSI: 28 Feb2009;LSLV:20 Dec 2011.
A total of 384 patients were screened (informed consent signed and CRF started) and 353 patients were randomized with 175 patients in the Tamoxifen group and 178 in the Arimidex group.
Participant milestones
| Measure |
Arimidex Group
Anastrozole(ARIMIDEX): 1 mg once daily oral dose
|
TAM Group
Tamoxifen : 20 mg once daily oral dose
|
|---|---|---|
|
Overall Study
STARTED
|
178
|
175
|
|
Overall Study
COMPLETED
|
149
|
114
|
|
Overall Study
NOT COMPLETED
|
29
|
61
|
Reasons for withdrawal
| Measure |
Arimidex Group
Anastrozole(ARIMIDEX): 1 mg once daily oral dose
|
TAM Group
Tamoxifen : 20 mg once daily oral dose
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
23
|
|
Overall Study
Adverse Event
|
8
|
15
|
|
Overall Study
Lost to Follow-up
|
9
|
15
|
|
Overall Study
Protocol Violation
|
2
|
6
|
|
Overall Study
Severe Non-Compliance to Protocol
|
4
|
2
|
Baseline Characteristics
Liver Safety Under Upfront Arimidex vs Tamoxifen
Baseline characteristics by cohort
| Measure |
Arimidex Group
n=178 Participants
Anastrozole(ARIMIDEX): 1 mg once daily oral dose
|
TAM Group
n=175 Participants
Tamoxifen : 20 mg once daily oral dose
|
Total
n=353 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
59.7 years
STANDARD_DEVIATION 7.77 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 8.84 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 8.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
353 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 48 weeks, 96 weeks, 144 weeksThe primary objective is to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidence of fatty liver diseases.
Outcome measures
| Measure |
Arimidex Group
n=178 Participants
Anastrozole(ARIMIDEX): 1 mg once daily oral dose
|
TAM Group
n=175 Participants
Tamoxifen : 20 mg once daily oral dose
|
|---|---|---|
|
Incidence of Fatty Liver Disease
48 weeks
|
9 participants
|
53 participants
|
|
Incidence of Fatty Liver Disease
96 weeks
|
15 participants
|
66 participants
|
|
Incidence of Fatty Liver Disease
144 weeks
|
26 participants
|
72 participants
|
SECONDARY outcome
Timeframe: At 48 weeks, 96 weeks, 144 weeksThe second objectives are to compare ARIMIDEX (anastrozole) 1 mg once daily with Tamoxifen 20 mg once daily as adjuvant treatment in terms of: incidences of abnormal liver function test, and time to treatment failure.
Outcome measures
| Measure |
Arimidex Group
n=178 Participants
Anastrozole(ARIMIDEX): 1 mg once daily oral dose
|
TAM Group
n=175 Participants
Tamoxifen : 20 mg once daily oral dose
|
|---|---|---|
|
Incidence of Abnormal Liver Function
48 weeks
|
29 participants
|
36 participants
|
|
Incidence of Abnormal Liver Function
96 weeks
|
37 participants
|
40 participants
|
|
Incidence of Abnormal Liver Function
144 weeks
|
44 participants
|
43 participants
|
SECONDARY outcome
Timeframe: Within 3 yearsOutcome measures
| Measure |
Arimidex Group
n=178 Participants
Anastrozole(ARIMIDEX): 1 mg once daily oral dose
|
TAM Group
n=175 Participants
Tamoxifen : 20 mg once daily oral dose
|
|---|---|---|
|
Time to Treatment Failure
|
1112 days
Interval 1053.0 to
The upper limit of 95% Confidence Interval for Median of Time to treatment failure was substantially longer than 1122 and was not observed during the trial period.
|
454 days
Interval 353.0 to 673.0
|
Adverse Events
Arimidex Group
Serious events: 4 serious events
Other events: 39 other events
Deaths: 0 deaths
TAM Group
Serious events: 4 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arimidex Group
n=178 participants at risk
Anastrozole(ARIMIDEX): 1 mg once daily oral dose
|
TAM Group
n=175 participants at risk
Tamoxifen : 20 mg once daily oral dose
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.56%
1/178
|
0.00%
0/175
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.56%
1/178
|
0.00%
0/175
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.56%
1/178
|
0.00%
0/175
|
|
Infections and infestations
Cervicitis
|
0.00%
0/178
|
1.1%
2/175
|
|
Cardiac disorders
Cardiac failure
|
0.56%
1/178
|
0.00%
0/175
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.00%
0/178
|
0.57%
1/175
|
|
Reproductive system and breast disorders
Uterine atony
|
0.00%
0/178
|
0.57%
1/175
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst
|
0.00%
0/178
|
0.57%
1/175
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.56%
1/178
|
0.00%
0/175
|
Other adverse events
| Measure |
Arimidex Group
n=178 participants at risk
Anastrozole(ARIMIDEX): 1 mg once daily oral dose
|
TAM Group
n=175 participants at risk
Tamoxifen : 20 mg once daily oral dose
|
|---|---|---|
|
Reproductive system and breast disorders
Endometrial Hypertrophy
|
0.00%
0/178
|
5.7%
10/175
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.56%
1/178
|
5.1%
9/175
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.56%
1/178
|
2.9%
5/175
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.2%
11/178
|
1.1%
2/175
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.4%
6/178
|
0.57%
1/175
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
3.4%
6/178
|
0.00%
0/175
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.7%
3/178
|
2.3%
4/175
|
|
Infections and infestations
Nasopharyngitis
|
3.4%
6/178
|
4.0%
7/175
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.8%
5/178
|
1.7%
3/175
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60