| ID | Type | Description | Link |
|---|---|---|---|
| 212082BCA2001 | Other Identifier | Janssen Research & Development, LLC | |
| 2011-000621-80 | EudraCT Number |
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The purpose of this study is to assess the safety and efficacy of oral abiraterone acetate plus oral prednisone and oral abiraterone acetate plus oral prednisone plus oral exemestane, each compared with oral exemestane alone, in postmenopausal women with estrogen receptor-positive (ER+) metastatic (spreading) breast cancer that has relapsed after treatment with letrozole or anastrozole.
This is a randomized (study drug assigned by chance), open-label (all participants will know the identity of the assigned study drug) study divided into three phases, screening, treatment, and follow-up. During screening, potential patients will be assessed for study eligibility after providing signed informed consent. The treatment phase will comprise a series of 28-day cycles with continuous study treatment until breast cancer progression, when an end-of-treatment visit will be completed before the follow-up phase begins. The duration of participation in the study for an individual patient may be up to approximately 7 years, including follow-up evaluations. Patients will be evaluated for the safety and effectiveness of study treatments. During the treatment phase, patients will take the following study drugs by mouth once daily: abiraterone acetate, 1 g/day, as four 250-mg tablets, on an empty stomach, and patients must not eat for at least 1 hour after abiraterone acetate; prednisone (prednisolone when prednisone is not available), 5 mg/day; and exemestane, 25 mg/day, as a single tablet. The treatment phase will consist of a series of 28-day cycles with continuous study treatment until breast cancer progression. At the planned interim analysis, the Data Review Committee has recommended that further randomization to the abiraterone acetate alone group be stopped and that the study is to be continued otherwise.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abiraterone acetate + Prednisone or Prednisolone | Experimental | Abiraterone acetate + Prednisone or Prednisolone Abiraterone acetate type=equal unit=mg number=250 form=tablet route=oral use 4 tablets Prednisone or Prednisolone type=equal unit=mg number=5 form=tablet route=oral use. All drugs are taken once daily. |
|
| Abiraterone acetate + Prednisone/Prednisolone + Exemestane | Experimental | Abiraterone acetate + Prednisone/Prednisolone + Exemestane Abiraterone acetate type=equal unit=mg number=250 form=tablet route=oral use 4 tablets Prednisone or Prednisolone type=equal unit=mg number=5 form=tablet route=oral use Exemestane type=equal unit=mg number=25 form=tablet route=oral use. All drugs are taken once daily. |
|
| Exemestane | Experimental | Exemestane Exemestane type=equal unit=mg number=25 form=tablet route=oral use. All drugs are taken once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exemestane | Drug | Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Progression-free survival was defined as the time from randomization to first occurrence of disease progression (either radiographic or clinical), or death from any cause. PFS was determined using radiographic progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) on measurable lesions captured by computed tomography (CT) or magnetic resonance imaging (MRI). Clinical disease progression was considered only when disease progression could not be confirmed by CT or MRI, such as when the disease site is skin, bone marrow, or central nervous system. | Approximately 2 years |
| Overall Survival (OS) | OS was calculated as the time from randomization to death from any cause. | Approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Overall response rate was defined as the percentage of participants with measurable disease achieving a best overall response of either complete response (CR) or partial response (PR) based on RECIST. CR: disappearance of all target lesions and non-target lesions. PR: at least a 30 percent (%) decrease in the sum of longest diameter (LD) of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Muscle Shoals | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26504153 | Derived | O'Shaughnessy J, Campone M, Brain E, Neven P, Hayes D, Bondarenko I, Griffin TW, Martin J, De Porre P, Kheoh T, Yu MK, Peng W, Johnston S. Abiraterone acetate, exemestane or the combination in postmenopausal patients with estrogen receptor-positive metastatic breast cancer. Ann Oncol. 2016 Jan;27(1):106-13. doi: 10.1093/annonc/mdv487. Epub 2015 Oct 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exemestane | Participants received exemestane tablet as oral dose of 25 milligram (mg) per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years). |
| FG001 | Abiraterone Acetate + Prednisone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 27, 2015 | May 9, 2018 |
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| Abiraterone acetate + Prednisone/ Prednisolone + Exemestane | Drug | Prednisone or Prednisolone, type=equal, unit=mg, number=5, form=tablet, route=oral use. All drugs are taken once daily. |
|
| Abiraterone acetate + Prednisone or Prednisolone | Drug | Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets |
|
| Approximately 2 years |
| Clinical Benefit Rate | Clinical benefit rate was defined as the percentage of participants with measurable disease achieving a best overall response of a CR, PR, or stable disease (SD) for at least 6 months based on RECIST. Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits. | Approximately 2 years |
| Duration of Response | Duration of objective response was measured from the first time that the CR or PR was achieved to the first observation of disease progression (either radiographic or clinical) based on the RECIST criteria. | Approximately 2 years |
| Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment | Change from baseline in serum endocrine biomarkers (estradiol and estrone) was summarized by treatment at end of treatment. | Baseline and End of treatment (approximately 2 years) |
| Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment | Change from baseline in serum endocrine biomarkers (Progesterone and Testosterone) was summarized by treatment at end of treatment. | Baseline and End of treatment (approximately 2 years) |
| Fresno |
| California |
| United States |
| Los Angeles | California | United States |
| Monterey | California | United States |
| Chicago | Illinois | United States |
| Waterville | Maine | United States |
| Boston | Massachusetts | United States |
| Ann Arbor | Michigan | United States |
| Henderson | Nevada | United States |
| East Syracuse | New York | United States |
| Johnson City | New York | United States |
| New York | New York | United States |
| Durham | North Carolina | United States |
| Fargo | North Dakota | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Kettering | Ohio | United States |
| Portland | Oregon | United States |
| Sioux Falls | South Dakota | United States |
| Dallas | Texas | United States |
| El Paso | Texas | United States |
| Houston | Texas | United States |
| Tyler | Texas | United States |
| Seattle | Washington | United States |
| Antwerp | Belgium |
| Brussels | Belgium |
| Duffel | Belgium |
| Edegem | Belgium |
| Ghent | Belgium |
| Hasselt | Belgium |
| Leuven | Belgium |
| Liège | Belgium |
| Wilrijk | Belgium |
| Bordeaux | France |
| Caen | France |
| Pierre-Bénite | France |
| Saint-Cloud | France |
| Saint-Herblain | France |
| Galway | Ireland |
| Limerick | Ireland |
| Luxembourg | Luxembourg |
| Niedercorn | Luxembourg |
| Alkmaar | Netherlands |
| Amsterdam | Netherlands |
| Heerlen | Netherlands |
| Leeuwarden | Netherlands |
| Leiden | Netherlands |
| Rotterdam | Netherlands |
| Sittard | Netherlands |
| Bialystok | Poland |
| Warsaw | Poland |
| Chelyabinsk | Russia |
| Kazan' | Russia |
| Leningrad Region | Russia |
| Moscow | Russia |
| Saint Petersburg | Russia |
| Sochi | Russia |
| Stavropol | Russia |
| Vladimir | Russia |
| Busan | South Korea |
| Seoul | South Korea |
| Suwon | South Korea |
| Barcelona | Spain |
| Madrid | Spain |
| Seville | Spain |
| Valencia | Spain |
| Cherkasy | Ukraine |
| Chernivtsi | Ukraine |
| Dnipro | Ukraine |
| Donetsk | Ukraine |
| Kharkiv | Ukraine |
| Odesa | Ukraine |
| Uzhhorod | Ukraine |
| Bath | United Kingdom |
| Birmingham | United Kingdom |
| Exeter | United Kingdom |
| London | United Kingdom |
| Nottingham | United Kingdom |
| Plymouth | United Kingdom |
| Sheffield | United Kingdom |
| Sutton | United Kingdom |
Participants received abiraterone acetate tablet at a total oral dose of 1000 milligram (mg) along with 5 mg capsule of prednisone/prednisolone per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years). |
| FG002 | Abiraterone Acetate + Exemestane + Prednisone | Participants received abiraterone acetate tablet at a total oral dose of 1000 mg and 5 mg capsule of prednisone/prednisolone along with exemestane tablet 25 mg per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years). |
| Treated |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exemestane | Participants received exemestane tablet as oral dose of 25 milligram (mg) per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years). |
| BG001 | Abiraterone Acetate + Prednisone | Participants received abiraterone acetate tablet at a total oral dose of 1000 milligram (mg) along with 5 mg capsule of prednisone/prednisolone per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years). |
| BG002 | Abiraterone Acetate + Exemestane + Prednisone | Participants received abiraterone acetate tablet at a total oral dose of 1000 mg and 5 mg capsule of prednisone/prednisolone along with exemestane tablet 25 mg per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years). |
| 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 |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | 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 (PFS) | Progression-free survival was defined as the time from randomization to first occurrence of disease progression (either radiographic or clinical), or death from any cause. PFS was determined using radiographic progression defined by Response Evaluation Criteria in Solid Tumors (RECIST) on measurable lesions captured by computed tomography (CT) or magnetic resonance imaging (MRI). Clinical disease progression was considered only when disease progression could not be confirmed by CT or MRI, such as when the disease site is skin, bone marrow, or central nervous system. | Intent-to-Treat (ITT) analysis set included all participants randomized into the study. | Posted | Median | 95% Confidence Interval | Months | Approximately 2 years |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Overall Survival (OS) | OS was calculated as the time from randomization to death from any cause. | ITT analysis set included all participants randomized into the study. | Posted | Median | 95% Confidence Interval | Months | Approximately 3 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Overall Response Rate (ORR) | Overall response rate was defined as the percentage of participants with measurable disease achieving a best overall response of either complete response (CR) or partial response (PR) based on RECIST. CR: disappearance of all target lesions and non-target lesions. PR: at least a 30 percent (%) decrease in the sum of longest diameter (LD) of target lesions or persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits. | ITT analysis set with measurable disease at baseline. | Posted | Number | Percentage of participants | Approximately 2 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Benefit Rate | Clinical benefit rate was defined as the percentage of participants with measurable disease achieving a best overall response of a CR, PR, or stable disease (SD) for at least 6 months based on RECIST. Stable disease: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study and persistence of one or more non-target lesion(s) and/or maintenance of tumour marker level above the normal limits. | ITT analysis set with measurable disease at baseline. | Posted | Number | Percentage of participants | Approximately 2 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of objective response was measured from the first time that the CR or PR was achieved to the first observation of disease progression (either radiographic or clinical) based on the RECIST criteria. | ITT analysis set with measurable disease at baseline with complete or partial response. | Posted | Median | 95% Confidence Interval | months | Approximately 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Endocrine Biomarkers (Estradiol and Estrone) at End of Treatment | Change from baseline in serum endocrine biomarkers (estradiol and estrone) was summarized by treatment at end of treatment. | ITT analysis set with valid baseline value and at least 1 post baseline value. Here "n" (number analyzed)" signifies participants evaluable for specified categories. | Posted | Mean | Standard Deviation | Picomoles Per Liter (Pmol/L) | Baseline and End of treatment (approximately 2 years) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Endocrine Biomarkers (Progesterone and Testosterone) at End of Treatment | Change from baseline in serum endocrine biomarkers (Progesterone and Testosterone) was summarized by treatment at end of treatment. | ITT analysis set with valid baseline value and at least 1 post baseline value. Here "n" (number analyzed)" signifies participants evaluable for specified categories. | Posted | Mean | Standard Deviation | Nanomoles Per Liter (nmol/L) | Baseline and End of treatment (approximately 2 years) |
|
Approximately 3 years
Safety population was defined as all randomized participants who received at least one dose of study drug.
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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 | Exemestane | Participants received exemestane tablet as oral dose of 25 milligram (mg) per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years). | 1 | 102 | 12 | 102 | 79 | 102 |
| EG001 | Abiraterone Acetate + Prednisone | Participants received abiraterone acetate tablet at a total oral dose of 1000 milligram (mg) along with 5 mg capsule of prednisone/prednisolone per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years). | 0 | 87 | 18 | 87 | 76 | 87 |
| EG002 | Abiraterone Acetate + Exemestane + Prednisone | Participants received abiraterone acetate tablet at a total oral dose of 1000 mg and 5 mg capsule of prednisone/prednisolone along with exemestane tablet 25 mg per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years). | 2 | 104 | 28 | 104 | 84 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypoaldosteronism | Endocrine disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Anorectal Varices | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Crohn's Disease | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Faecal Incontinence | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Small Intestinal Obstruction | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Volvulus of Small Bowel | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hepatitis Toxic | Hepatobiliary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Device Related Infection | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Compression Fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hip Fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Lower Limb Fracture | Injury, poisoning and procedural complications | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Flank Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Mobility Decreased | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pathological Fracture | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Synovial Cyst | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Metastases to Bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Metastases to Peripheral Nervous System | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Metastases to Pleura | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Balance Disorder | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Vascular Encephalopathy | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Urinary Retention | Renal and urinary disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pulmonary Toxicity | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Peripheral Artery Stenosis | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Influenza Like Illness | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Alanine Aminotransferase Increased | Investigations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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| Hot Flush | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 16.0 | Non-systematic Assessment |
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A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Director Clinical Development | Janssen Research & Development, LLC | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 30, 2013 | May 9, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C056516 | exemestane |
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D011246 | Pregnadienetriols |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Belgium |
|
| France |
|
| Spain |
|
| United Kingdom |
|
| Italy |
|
| Korea, Republic Of |
|
| Netherlands |
|
| Russia |
|
| Ukraine |
|
| Hazard Ratio (HR) |
| 0.958 |
| 2-Sided |
| 95 |
| 0.695 |
| 1.320 |
| Superiority |
| Units | Counts |
|---|---|
| Participants |
|
|
|
Participants received abiraterone acetate tablet at a total oral dose of 1000 mg and 5 mg capsule of prednisone/prednisolone along with exemestane tablet 25 mg per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).
|
|
|
Participants received abiraterone acetate tablet at a total oral dose of 1000 mg and 5 mg capsule of prednisone/prednisolone along with exemestane tablet 25 mg per day in 28-day treatment cycles until disease progression, unacceptable toxicity, or death (up to 3 years).
|
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