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| ID | Type | Description | Link |
|---|---|---|---|
| ABCSG21 | |||
| Eudract No 2005-005715-22 |
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Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells, clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole and fulvestrant or anastrozole alone in patients with early breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Anastrozole monotherapy |
|
| 2 | Experimental | Anastrozole + Fulvestrant |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulvestrant | Drug | intramuscular injection |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence) | Number of patients event-free | 12 month period following randomisation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Breast Cancer Established Brands Team Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Feldkirch | Austria | ||||
| Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fulvestrant + Anastrozole | fulvestrant 500 mg + anastrozole 1 mg |
| FG001 | Anastrozole | anastrozole 1 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Anastrozole | Drug | 1 mg oral tablet |
|
|
| Graz |
| Austria |
| Research Site | Innsbruck | Austria |
| Research Site | Klagenfurt | Austria |
| Research Site | Leoben | Austria |
| Research Site | Linz | Austria |
| Research Site | Salzburg | Austria |
| Research Site | Sankt Veit im Pongau | Austria |
| Research Site | Vienna | Austria |
| Research Site | Wiener Neustadt | Austria |
| Research Site | Bayreuth | Germany |
| Research Site | Essen | Germany |
| Research Site | Hamburg-Eppendorf | Germany |
| Research Site | Heidelberg | Germany |
| Research Site | Munich | Germany |
| Research Site | Rostock | Germany |
| Research Site | Tübingen | Germany |
| Research Site | Drammen | Norway |
| Research Site | Fredrikstad | Norway |
| Research Site | Kristiansand | Norway |
| Research Site | Oslo | Norway |
| Research SIte | Porsgrunn | Norway |
| Research Site | Stavanger | Norway |
| Research Site | Trondheim | Norway |
| Research Site | Tønsberg | Norway |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fulvestrant + Anastrozole | fulvestrant 500 mg + anastrozole 1 mg |
| BG001 | Anastrozole | anastrozole 1 mg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | age in years at baseline |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence) | Number of patients event-free | Posted | Number | Participants | 12 month period following randomisation |
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|
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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 | Fulvestrant + Anastrozole | fulvestrant 500 mg + anastrozole 1 mg | 1 | 6 | 5 | 6 | ||
| EG001 | Anastrozole | anastrozole 1 mg | 2 | 7 | 5 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Goitre | Endocrine disorders | MedDRA 10.0 | Systematic Assessment |
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| Haemorrhoid Operation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA 10.0 |
| ||
| Varicose Vein | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Hot Flush | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Lymphoedema | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Unevaluable Event | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Injection Site Pruritus | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Depressed Mood | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Mood Altered | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Seroma | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Weight Decreased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Weight Increased | Investigations | MedDRA 10.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
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| Renal Pain | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Xeroderma | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Keratitis Herpetic | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
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| Vaginal Discharge | Reproductive system and breast disorders | MedDRA 10.0 | Systematic Assessment |
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The PI will provide ASTRAZENECA as soon as possible with preliminary data and drafts of proposed results communications and with the proposed final draft at least 14 days prior to submission of an abstract and 30 days prior to submission of a manuscript. ASTRAZENECA can, upon written request, embargo communications regarding trial results for no more than 45 days from the date of the written request. ASTRAZENECA cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077267 | Fulvestrant |
| D000077384 | Anastrozole |
| ID | Term |
|---|---|
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|