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The purpose of this study is to determine whether AZD2171 can effectively improve time to tumour progression when added to fulvestrant in patients with advanced hormone sensitive breast cancer who progressed on prior hormonal therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Active Comparator | Fulvestrant Monotherapy |
|
| 3 | Experimental | AZD2171 + Fulvestrant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2171 | Drug | Oral tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression. | RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | Best objective tumour response (based on Response Evaluation Criteria in Solid Tumours (RECIST)) during the study for patients with measurable disease. Best objective tumour response defined as: Complete Response (CR) Disappearance of all target lesions Partial response (PR) At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs. Progression (PD) At least a 20% increase in the sum of LDs of target lesions, taking as reference the smallest sum of LDs since treatment started (including the baseline sum of LDs) and at least 5 mm increase. Stable disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bijoyesh Mookerjee, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Burbank | California | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23801303 | Derived | Hyams DM, Chan A, de Oliveira C, Snyder R, Vinholes J, Audeh MW, Alencar VM, Lombard J, Mookerjee B, Xu J, Brown K, Klein P. Cediranib in combination with fulvestrant in hormone-sensitive metastatic breast cancer: a randomized Phase II study. Invest New Drugs. 2013 Oct;31(5):1345-54. doi: 10.1007/s10637-013-9991-2. Epub 2013 Jun 26. |
| Label | URL |
|---|---|
| CSR-D8480C00007.pdf | View source |
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In this study, 75 patients were enrolled and 62 randomised.
Randomised=ITT=Safety: Cediranib 31, Placebo 31
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| ID | Title | Description |
|---|---|---|
| FG000 | Cediranib 45 mg | Cediranib 45 mg+Fulvestrant 250 mg Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:
|
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Fulvestrant |
| Drug |
intramuscular injection |
|
|
| RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest. |
| Duration of Response | Number of days from date of response (complete/partial based on RECIST) to date of progression | Every 8 weeks until progression or discontinuation |
| Clinical Benefit Rate | Clinical Benefit is defined as the number of patients having a best overall tumour response of CR/PR or SD for ≥6 months. The Clinical Benefit rate is defined as the number of responders divided by the number in the Intention-to-treat (ITT) analysis set: responder=overall best response of complete response (CR)/partial response (PR) or stable disease (SD) for at least 6 months (calculated from the date of randomisation) as defined by RECIST criteria at any point prior to the data cut-off. | Every 8 weeks until progression or discontinuation |
| Duration of Clinical Benefit | Number of days from date of clinical benefit to date of progression. Clinical benefit is defined as having a best overall tumour response of CR/PR or SD for ≥6 months. | Every 8 weeks until progression or discontinuation |
| Los Angeles |
| California |
| United States |
| Research Site | Palm Springs | California | United States |
| Research Site | Boca Raton | Florida | United States |
| Research Site | Honolulu | Hawaii | United States |
| Research Site | New York | New York | United States |
| Research Site | Fitzroy | Australia |
| Research Site | Parkville | Australia |
| Research Site | Perth | Australia |
| Research Site | Waratah | Australia |
| Research Site | Belo Horizonte | Brazil |
| Research Site | Curitiba | Brazil |
| Research Site | Fortaleza | Brazil |
| Research Site | Porto Alegre | Brazil |
| Research Site | Santro Andre | Brazil |
| Research Site | São Paulo | Brazil |
| FG001 |
| Placebo |
Placebo+Fulvestrant 250 mg Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:
|
| COMPLETED |
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| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cediranib 45 mg | Cediranib 45 mg+Fulvestrant 250 mg Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:
|
| BG001 | Placebo | Placebo+Fulvestrant 250 mg Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:
|
| 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 | Years |
| |||||||||||||||
| 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 | Progression Free Survival | Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression. | Posted | Median | 95% Confidence Interval | Days | RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest. |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Objective Response Rate | Best objective tumour response (based on Response Evaluation Criteria in Solid Tumours (RECIST)) during the study for patients with measurable disease. Best objective tumour response defined as: Complete Response (CR) Disappearance of all target lesions Partial response (PR) At least a 30% decrease in the sum of longest diameters (LDs) of target lesions, taking as reference the baseline sum of LDs. Progression (PD) At least a 20% increase in the sum of LDs of target lesions, taking as reference the smallest sum of LDs since treatment started (including the baseline sum of LDs) and at least 5 mm increase. Stable disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD | Posted | Number | Participants | RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest. |
| ||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Number of days from date of response (complete/partial based on RECIST) to date of progression | Posted | Median | Full Range | Days | Every 8 weeks until progression or discontinuation |
|
| ||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate | Clinical Benefit is defined as the number of patients having a best overall tumour response of CR/PR or SD for ≥6 months. The Clinical Benefit rate is defined as the number of responders divided by the number in the Intention-to-treat (ITT) analysis set: responder=overall best response of complete response (CR)/partial response (PR) or stable disease (SD) for at least 6 months (calculated from the date of randomisation) as defined by RECIST criteria at any point prior to the data cut-off. | Posted | Number | Ratio | Every 8 weeks until progression or discontinuation |
| ||||||||||||||||||||||||||||||||
| Secondary | Duration of Clinical Benefit | Number of days from date of clinical benefit to date of progression. Clinical benefit is defined as having a best overall tumour response of CR/PR or SD for ≥6 months. | Posted | Mean | Standard Deviation | Days | Every 8 weeks until progression or discontinuation |
|
|
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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 | Cediranib 45 mg | Cediranib 45 mg+Fulvestrant 250 mg Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:
| 15 | 31 | 29 | 31 | ||
| EG001 | Placebo | Placebo+Fulvestrant 250 mg Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:
| 4 | 31 | 30 | 31 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intracardiac Thrombus | Cardiac disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Multi-Organ Failure | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Weight Decreased | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Water Intoxication | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypothyroidism | Endocrine disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Gingival Bleeding | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Injection Site Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Weight Decreased | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Weight Increased | Infections and infestations | MedDRA 11.1 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Peripheral Sensory Neuropathy | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 11.1 | Systematic Assessment |
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| Breast Pain | Reproductive system and breast disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dry Throat | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Palmar-Plantar Erythrodysaesthesia Syndrome | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
| |
| Hot Flush | Vascular disorders | MedDRA 11.1 | Systematic Assessment |
|
If a Study Site, or an investigator, requests permission to publish data from this study, any such publication (including oral presentations) is to be agreed with AstraZeneca prior to publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| C500926 | cediranib |
| 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 |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|