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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.
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Anastrozole (ARIMIDEX) |
|
| 2 | Active Comparator | Tamoxifen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anastrozole | Drug | 1 mg once daily oral dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Fatty Liver Disease | 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. | At 48 weeks, 96 weeks, 144 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Abnormal Liver Function | The 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. | At 48 weeks, 96 weeks, 144 weeks |
| Time to Treatment Failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivian Gu | AstraZeneca | Study Director |
| Fengping Liang | AstraZeneca | Study Chair |
| Prof. Wang Shenming | AstraZeneca | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Fuzhou | Fujian | China | |||
| Research Site |
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.
Patients were enrolled in 28 centres in the People's Republic of China. FSI: 18Sep2007; LSI: 28 Feb2009;LSLV:20 Dec 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arimidex Group | Anastrozole(ARIMIDEX): 1 mg once daily oral dose |
| FG001 | TAM Group | Tamoxifen : 20 mg once daily oral dose |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arimidex Group | Anastrozole(ARIMIDEX): 1 mg once daily oral dose |
| BG001 | TAM Group | Tamoxifen : 20 mg once daily oral dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Fatty Liver Disease | 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. | Posted | Number | participants | At 48 weeks, 96 weeks, 144 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arimidex Group | Anastrozole(ARIMIDEX): 1 mg once daily oral dose |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endometrial Hypertrophy | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James J. Armbrust | AstraZeneca | +44 1625 518062 | ClinicalTrialTransparency@astrazeneca.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077384 | Anastrozole |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| Tamoxifen | Drug | 20 mg once daily oral dose |
|
|
| Within 3 years |
| Guangzhou |
| Guangdong |
| China |
| Research Site | Nanning | Guangxi | China |
| Research Site | Wuchang | Hubei | China |
| Research Site | Wuhan | Hubei | China |
| Research Site | Nanjing | Jiangsu | China |
| Research Site | Changchun | Jilin | China |
| Research Site | Dalian | Liaoning | China |
| Research Site | Jinan | Shandong | China |
| Research Site | Shanghai | Shanghai Municipality | China |
| Research Site | Taiyuan | Shanxi | China |
| Research Site | Xian | Shanxi | China |
| Research Site | Chengdu | Sichuan | China |
| Research Site | Kunming | Yunnan | China |
| Research Site | Hangzhou | Zhejiang | China |
| Research Site | Tianjin | China |
| Lost to Follow-up |
|
| Protocol Violation |
|
| Severe Non-Compliance to Protocol |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Participants |
|
|
| Secondary | Incidence of Abnormal Liver Function | The 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. | Posted | Number | participants | At 48 weeks, 96 weeks, 144 weeks |
|
|
|
| Secondary | Time to Treatment Failure | Posted | Median | 95% Confidence Interval | days | Within 3 years |
|
|
|
| 4 |
| 178 |
| 39 |
| 178 |
| EG001 | TAM Group | Tamoxifen : 20 mg once daily oral dose | 4 | 175 | 41 | 175 |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
|
| Cervicitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA 10.0 | Systematic Assessment |
|
| Uterine atony | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.0 | Systematic Assessment |
|
| Hepatic cyst | Hepatobiliary disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| 144 weeks |
|