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| ID | Type | Description | Link |
|---|---|---|---|
| FINDER II |
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This study will assess the relationship between fulvestrant dose and efficacy in postmenopausal women with oestrogen receptor positive advanced breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Fulvestrant 250 mg (intramuscular injection 250 mg) |
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| 2 | Experimental | Fulvestrant 250 mg (+ 250 mg loading regimen) |
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| 3 | Experimental | Fulvestrant 500 mg (intramuscular injection 500 mg) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fulvestrant | Drug | intramuscular injection 250 mg & 500 mg |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response (ORR) | Objective response rate was defined as percentage of patients with either complete response (CR - disappearance of all target lesions) or partial response (PR - at least 30% decrease in the sum of diameters of target lesions). All patients were to be followed up every 12 weeks for progression, defined by response evaluation criteria in solid tumors (RECIST v1.1). | The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Progression (TTP) | Time from randomisation until objective disease progression or death (in the absence of objective progression) using the Kaplan-Meier method. RECIST tumor assessments were carried out every 12 weeks until progression. | The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Breast Cancer Established Brands Team Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Brussels | 1000 | Belgium | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20632084 | Derived | Pritchard KI, Rolski J, Papai Z, Mauriac L, Cardoso F, Chang J, Panasci L, Ianuli C, Kahan Z, Fukase K, Lindemann JP, Macpherson MP, Neven P. Results of a phase II study comparing three dosing regimens of fulvestrant in postmenopausal women with advanced breast cancer (FINDER2). Breast Cancer Res Treat. 2010 Sep;123(2):453-61. doi: 10.1007/s10549-010-1022-9. Epub 2010 Jul 15. |
| Label | URL |
|---|---|
| Related Info | View source |
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Postmenopausal women with oestrogen receptor positive advanced breast cancer progressing or relapsing after previous endocrine therapy were randomised between 30th May 2006 and 30th November 2007
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| ID | Title | Description |
|---|---|---|
| FG000 | Fulvestrant 250 mg | Fulvestrant 250 mg |
| FG001 | Fulvestrant 250 mg + Loading Dose | Fulvestrant 250 mg + Loading Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Duration of Response (DoR) | DoR was defined as the time from date of first documentation of the response (CR or PR) until the date of disease progression or death from any cause. | The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years. |
| Clinical Benefit Rate (CBR) | CBR was defined as the proportion of all randomised patients who had clinical benefit (response of CR, PR or SD>=24 weeks. | The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years. |
| Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body | A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean. | Baseline to 12 weeks |
| Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes | A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean. The mean estimate of volume of distribution at steady state was reported as the sum of V1/F and V2/F in the clinical study report. | Baseline to 12 weeks |
| Leuven |
| 3000 |
| Belgium |
| Research Site | Roeselare | 8800 | Belgium |
| Research Site | Wilrijk | 2610 | Belgium |
| Research Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Research Site | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Research Site | Cambridge | Ontario | N1R 3G2 | Canada |
| Research Site | London | Ontario | N6A 4L6 | Canada |
| Research Site | Oshawa | Ontario | L1G 2B9 | Canada |
| Research Site | Sault Ste. Marie | Ontario | P6A 2C4 | Canada |
| Research Site | Toronto | Ontario | M4C 3E7 | Canada |
| Research Site | Toronto | Ontario | M4N 3M5 | Canada |
| Research Site | Montreal | Quebec | H3T 1E2 | Canada |
| Research Site | Québec | Quebec | G1S 4L8 | Canada |
| Research Site | Cheb | 350 02 | Czechia |
| Research Site | Jičín | 506 43 | Czechia |
| Research Site | Prague | 140 00 | Czechia |
| Research Site | Bordeaux | 33000 | France |
| Research Site | Brivé | 19312 | France |
| Research Site | Clermont-Ferrand | 63011 | France |
| Research Site | Poitiers | 86000 | France |
| Research Site | Budapest | 1062 | Hungary |
| Research Site | Debrecen | 4032 | Hungary |
| Research Site | Győr | 9024 | Hungary |
| Research Site | Szeged | 6720 | Hungary |
| Research Site | Tatabánya | 2800 | Hungary |
| Research Site | Bydgoszcz | 85-796 | Poland |
| Research Site | Gdansk | 80-214 | Poland |
| Research Site | Gdansk | 80-462 | Poland |
| Research Site | Krakow | 31-115 | Poland |
| Research Site | Olsztyn | 10-228 | Poland |
| Research Site | Bucharest | Romania |
| Research Site | Cluj-Napoca | 40015 | Romania |
| Research Site | Istanbul | Turkey (Türkiye) |
| CSR-D6997C00006.pdf | View source |
| FG002 | Fulvestrant 500 mg | Fulvestrant 500 mg |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fulvestrant 250 mg | Fulvestrant 250 mg |
| BG001 | Fulvestrant 250 mg + Loading Dose | Fulvestrant 250 mg + Loading Dose |
| BG002 | Fulvestrant 500 mg | Fulvestrant 500 mg |
| BG003 | 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 | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| 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 | Objective Response (ORR) | Objective response rate was defined as percentage of patients with either complete response (CR - disappearance of all target lesions) or partial response (PR - at least 30% decrease in the sum of diameters of target lesions). All patients were to be followed up every 12 weeks for progression, defined by response evaluation criteria in solid tumors (RECIST v1.1). | Full analysis set | Posted | Number | 95% Confidence Interval | Percentage of patients | The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years. |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | Time to Progression (TTP) | Time from randomisation until objective disease progression or death (in the absence of objective progression) using the Kaplan-Meier method. RECIST tumor assessments were carried out every 12 weeks until progression. | Full analysis set | Posted | Median | Inter-Quartile Range | Days | The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years. |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) | DoR was defined as the time from date of first documentation of the response (CR or PR) until the date of disease progression or death from any cause. | All objective responders | Posted | Median | Inter-Quartile Range | Days | The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years. |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate (CBR) | CBR was defined as the proportion of all randomised patients who had clinical benefit (response of CR, PR or SD>=24 weeks. | Full analysis set | Posted | Number | 95% Confidence Interval | Percentage of patients | The planned data cut-off for this study was when all patients, except withdrawals, had been followed up for at least 24 weeks. Patients received treatment up to approximately 2 years. |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter: Mean Population Clearance, a Measure of the Efficiency With Which Fulvestrant is Eliminated From the Body | A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean. | Participants who had PK samples only | Posted | Least Squares Mean | Standard Error | litres per hour | Baseline to 12 weeks |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetic Parameter: Mean Volume of Distribution at Steady State, a Measure of the Apparent Volume in the Body Into Which Fulvestrant Distributes | A 2-compartment model with a 1st order absorption and 1st order elimination process was fitted to the fulvestrant concentration-time data. Relative standard error is reported for the mean. The mean estimate of volume of distribution at steady state was reported as the sum of V1/F and V2/F in the clinical study report. | Posted | Least Squares Mean | Standard Error | Liters | Baseline to 12 weeks |
|
|
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1 patient in the 250mg + LD arm was randomised but did not receive any randomised therapy. This patient is included in the efficacy summaries but is excluded from the safety summaries.
All-Cause Mortality: patients who died whilst on study treatment or during 56 days after the last fulvestrant injection.
Serious Adverse Events: Patients with SAE other than death are reported.
NOTE: Other Adverse Events include serious and non-serious AEs.
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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 250 mg | Fulvestrant 250 mg | 2 | 47 | 4 | 47 | 36 | 47 |
| EG001 | Fulvestrant 250 mg + Loading Dose | Fulvestrant 250 mg + Loading Dose | 4 | 50 | 9 | 50 | 35 | 50 |
| EG002 | Fulvestrant 500 mg | Fulvestrant 500 mg | 2 | 46 | 4 | 46 | 31 | 46 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Macular Hole | Eye disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Diverticulum Intestinal Haemorrhagic | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Melaena | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Hip Fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Meniscus Lesion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Amnesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Ischaemic Stroke | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Mental Disorder | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Renal Colic | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Herpes Zoster | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Urinary Tract Infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Weight Decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
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| Urinary Incontinence | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Hot Flush | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders |
| |||
| Anaemia | Blood and lymphatic system disorders |
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Not provided
| 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 |
| 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 |
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| Male |
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| Oriental (Japanese) |
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| Oriental (Asian other than Chinese or Japanese) |
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