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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-000698-57 | EudraCT Number | ||
| C3431007 | Other Identifier | Alias Study Number |
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| Name | Class |
|---|---|
| Astellas Pharma Inc | INDUSTRY |
| Medivation LLC, a wholly owned subsidiary of Pfizer Inc. | INDUSTRY |
The purpose of this study is to determine if enzalutamide is safe and effective in the treatment of patients with advanced breast cancer that express the androgen receptor but do not express the estrogen or progesterone receptor and are not Her2 amplified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide | Experimental | 160 mg administered as four 40 mg soft gelatin capsules orally once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug | 160 mg administered as four soft gelatin capsules orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Benefit at Week 16: Evaluable Population | Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of complete response (CR), partial response(PR), stable disease(SD) for >=16 weeks on radiologic imaging based on Investigator assessment using Response Evaluation Criteria in Solid Tumors version 1.1(RECIST 1.1). An estimate of the percentage and its exact 2-sided 85% confidence interval(CI) were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10mm short axis. PR: At least 30% decrease in sum of longest diameter (LD) of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference. | Week 16 |
| Percentage of Participants With Clinical Benefit at Week 16: Intent-to-Treat (ITT) Population | Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of CR, PR, or SD for >= 16 weeks on radiologic imaging based on Investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Benefit at Week 24: Evaluable Population | Percentage of participants with a clinical benefit at Week 24 defined as percentage of participants with a best response of CR, PR, or SD for >= 24 weeks on radiologic imaging based on investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference. |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Plasma Concentration of Enzalutamide and Its Metabolite | M2 was the metabolite of enzalutamide. The lower limit of quantitation (LLQ) was 0.0200 micrograms per milliliter (mcg/mL) for enzalutamide and M2. | Predose on Day 1 (Baseline), Week 9 and Week 17 |
| Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Pfizer CT.gov Call Center | Pfizer | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Cancer Centers | Colorado Springs | Colorado | 80907 | United States | ||
| Rocky Mountain Cancer Centers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35172518 | Derived | Kumar V, Yu J, Phan V, Tudor IC, Peterson A, Uppal H. Androgen Receptor Immunohistochemistry as a Companion Diagnostic Approach to Predict Clinical Response to Enzalutamide in Triple-Negative Breast Cancer. JCO Precis Oncol. 2017 Nov;1:1-19. doi: 10.1200/PO.17.00075. | |
| 29373071 | Derived | Traina TA, Miller K, Yardley DA, Eakle J, Schwartzberg LS, O'Shaughnessy J, Gradishar W, Schmid P, Winer E, Kelly C, Nanda R, Gucalp A, Awada A, Garcia-Estevez L, Trudeau ME, Steinberg J, Uppal H, Tudor IC, Peterson A, Cortes J. Enzalutamide for the Treatment of Androgen Receptor-Expressing Triple-Negative Breast Cancer. J Clin Oncol. 2018 Mar 20;36(9):884-890. doi: 10.1200/JCO.2016.71.3495. Epub 2018 Jan 26. |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Total of 118 participants with advanced androgen receptor positive (AR+) and triple-negative breast cancer (TNBC) were enrolled at total of 34 study sites in North America and Europe to attain total of 78 evaluable participants.
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| ID | Title | Description |
|---|---|---|
| FG000 | Enzalutamide | Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Week 24 |
| Percentage of Participants With Clinical Benefit at Week 24: ITT Population | Percentage of participants with a clinical benefit at Week 24 defined as percentage of participants with a best response of CR, PR, or SD for >= 24 weeks on radiologic imaging based on investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference. | Week 24 |
| Percentage of Participants With Best Objective Response: Evaluable Population | Percentage of participants with best objective response defined as percentage of participants with a best response of CR and PR based on investigator assessment of target, non-target and new lesions using RECIST 1.1. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. | From Baseline up to disease progression or death due to any cause (up to 87 Weeks) |
| Percentage of Participants With Best Objective Response: ITT Population | Percentage of participants with best objective response defined as percentage of participants with a best response of CR and PR based on investigator assessment of target, non-target and new lesions using RECIST 1.1. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. | From Baseline up to disease progression or death due to any cause (up to 87 Weeks) |
| Progression-Free Survival (PFS): Evaluable Population | PFS was defined as the time (in weeks) from the date of first dose of study drug to the date of documented disease progression or death due to any cause whichever occurs first as determined by the investigator using RECIST 1.1. As per RECIST 1.1, progression was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. | From Baseline up to disease progression or death due to any cause (up to 87 Weeks) |
| Progression-Free Survival: ITT Population | PFS was defined as the time (in weeks) from the date of first dose of study drug to the date of documented disease progression or death due to any cause whichever occurs first as determined by the investigator using RECIST 1.1. As per RECIST 1.1, progression was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. | From Baseline up to disease progression or death due to any cause (up to 87 Weeks) |
| Time to Response: Evaluable Population | The time to response is defined as the time from the date of first dose of study drug to initial CR or PR. Participants without response of CR or PR before the data cutoff date were censored at the last tumor assessment date before the data cutoff. Kaplan-Meier method was used to summarize time to response. | From first dose of study drug until first documentation of CR or PR or data censoring date, whichever occurred first (up to 87 Weeks) |
| Duration of Response: Evaluable Population | Duration of objective response is defined as the time from initial CR or PR to documented disease progression or death due to any cause, whichever occurs first. Participants without disease progression or death due to any cause before the data cutoff date were censored at the last tumor assessment date before the data cutoff. | From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (up to 87 Weeks) |
| Number of Participants With Postbaseline Laboratory Toxicities Grade 3 or 4 | Laboratory parameters included hematology parameters [low lymphocytes (10^6/L), neutrophils (10^6/L) and Leukocytes (10^9/L)] and chemistry parameters [high phosphate (mmol/L), bilirubin, Alkaline phosphatase (U/L) and glucose (mmol/L)]. Number of participants with postbaseline laboratory toxicity Grade 3 or 4 as per NCI-CTCAE (version 4.0) (Grade 3= Severe, Grade 4= Life-threatening) were reported. | From start of study treatment on Day 1 up to 30 days after the last dose of study drug (up to maximum of 9.6 years) |
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events that were absent before treatment or that worsened relative to pretreatment state between first dose of study drug and up to 30 days after last dose of study drug or the day prior to initiation of new anti-tumor treatment. AEs included both serious and non-serious AEs. |
| Baseline up to 87 weeks |
| Number of Participants With Study Drug Discontinuation Due to Adverse Events | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Data reported here is for study drug discontinuation due to adverse events. | Baseline up to 87 weeks |
| Number of Participants With Grade 3 or Higher Adverse Events | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. As per the NCI CTCAE, version 4.0, Grade 3= severe, Grade 4= life-threatening and Grade 5= death. Only the participants with treatment-emergent AEs of Grade 3 (severe) or higher grade were reported in this outcome measure. | Baseline up to 87 weeks |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Criteria: Systolic blood pressure (SBP):absolute SBP<90 millimeters of mercury (mmHg) and decrease from baseline (DFB)>30mmHg, absolute SBP>180mmHg and increase from baseline (IFB)>40 mmHg, final visit (FV) or 2 consecutive visits (CV) SBP>=20 mmHg change from baseline (CFB), most extreme post-baseline SBP>=140mmHg, most extreme post- baseline SBP>=180mmHg, most extreme SBP>=140mmHg and>=20 mmHg CFB, most extreme SBP>=180mmHg and>=20mmHg CFB; diastolic blood pressure (DBP): absolute DBP>105mmHg and IFB>30mmHg, absolute DBP<50mmHg and DFB>20mmHg, final visit or 2 consecutive visits DBP>=15mmHg CFB, most extreme post-baseline DBP>=90mmHg, most extreme post-baseline DBP>=105mmHg, most extreme DBP>=90mmHg and>=15mmHg CFB, most extreme DBP>=105mmHg and>=15mmHg CFB; heart rate<50beats per minute (BPM) and DFB>20BPM or heart rate>120BPM and IFB>30BPM. Only those categories, in which at least 1 participant had data were reported. | From start of study treatment on Day 1 up to 30 days after the last dose of study drug (up to maximum of 9.6 years) |
| Number of Participants With Change From Baseline in Laboratory Parameters Grades by 2 or More Grades | Laboratory tests included hematology parameters [low lymphocytes (10^6/L), white blood cells (10^9/L), neutrophils (10^6/L), hemoglobin gram per Liter(g/L) and platelets (10^9/L)] and chemistry parameters [mean albumin grams per Liter(g/L), calcium milli mole per Liter(mmol/L), Phosphate (mmol/L), alanine aminotransferase units per Liter(U/L), Aspartate aminotransferase (U/L), bilirubin micro mole per Liter, Alkaline phosphatase (U/L) and glucose (mmol/L)]. Number of participants with change from baseline in laboratory parameters Grades by 2 or More Grades as per NCI-CTCAE (version 4.0) (Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) were reported. | From start of study treatment on Day 1 up to 30 days after the last dose of study drug (up to maximum of 9.6 years) |
| Lakewood |
| Colorado |
| 80228 |
| United States |
| Rocky Mountain Cancer Center Sky Ridge | Lone Tree | Colorado | 80124 | United States |
| Rocky Mountain Cancer Centers | Lone Tree | Colorado | 80124 | United States |
| Florida Cancer Specialists | Altamonte Springs | Florida | 32701 | United States |
| Florida Cancer Specialists | Bonita Springs | Florida | 34135 | United States |
| Florida Cancer Specialists | Bradenton | Florida | 34209 | United States |
| Florida Cancer Specialists | Brandon | Florida | 33511 | United States |
| Florida Cancer Specialists | Cape Coral | Florida | 33914 | United States |
| Florida Cancer Specialists | Clearwater | Florida | 33761 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33905 | United States |
| Florida Cancer Specialist South Division | Fort Myers | Florida | 33908 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33908 | United States |
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | United States |
| Florida Cancer Specialists | Gainesville | Florida | 32605 | United States |
| Florida Cancer Specialists | Hudson | Florida | 34667 | United States |
| Florida Cancer Specialists | Largo | Florida | 33770 | United States |
| Florida Cancer Specialists | Naples | Florida | 34102 | United States |
| Florida Cancer Specialists | New Port Richey | Florida | 34655 | United States |
| Florida Cancer Specialists | Orange City | Florida | 32763 | United States |
| Florida Cancer Specialists | Orlando | Florida | 32806 | United States |
| Florida Cancer Specialists | Port Charlotte | Florida | 33980 | United States |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | United States |
| Florida Cancer Specialists | Sarasota | Florida | 34236 | United States |
| Florida Cancer Specialists | Spring Hill | Florida | 34608 | United States |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | United States |
| Florida Cancer Specialists | Tampa | Florida | 33607 | United States |
| Florida Cancer Specialists | Tavares | Florida | 32778 | United States |
| Florida Cancer Specialists | Venice | Florida | 34285 | United States |
| Florida Cancer Specialists | Venice | Florida | 34292 | United States |
| Northwestern Medical Faculty Foundation(NMFF)/ Women's Cancer Center Shared Laboratories | Chicago | Illinois | 60611 | United States |
| Northwestern Medical Faculty Foundation | Chicago | Illinois | 60611 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| The University of Chicago Medical Center, Investigational Drug Service Department of Pharmacy | Chicago | Illinois | 60637 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| University of Chicago Comprehensive Cancer Center at Silver Cross Hospital | New Lenox | Illinois | 60451 | United States |
| Indiana University Health Hospital | Indianapolis | Indiana | 46202 | United States |
| Indiana University Health Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
| Investigational Drug Services | Indianapolis | Indiana | 46202 | United States |
| Sidney and Lois Eskenazi Hospital | Indianapolis | Indiana | 46202 | United States |
| Springmill Medical Clinic | Indianapolis | Indiana | 46290 | United States |
| Oncology Hematology Care, Inc. | Crestview Hills | Kentucky | 41017 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| The West Clinic, PC | Corinth | Mississippi | 38834 | United States |
| The West Clinic, PC | Southaven | Mississippi | 38671 | United States |
| Siteman Cancer Center | City of Saint Peters | Missouri | 63376 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Washington University Infusion Center Pharmacy | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Siteman Cancer Center-South County | St Louis | Missouri | 63129 | United States |
| Siteman Cancer Center-West County | St Louis | Missouri | 63141 | United States |
| Hematology Oncology Associates of Northern NJ | Morristown | New Jersey | 07962 | United States |
| Memorial Sloan Kettering - I Chemotherapy Practice/Investigational Drug Service | New York | New York | 10065 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Cone Health Cancer Center | Greensboro | North Carolina | 27403 | United States |
| Wesley Long Community Hospital | Greensboro | North Carolina | 27403 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45211 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45219 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45230 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45236 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45242 | United States |
| Oncology Hematology Care, Inc. | Fairfield | Ohio | 45014 | United States |
| Greenville Health System | Greenville | South Carolina | 29605 | United States |
| Greenville Health System | Seneca | South Carolina | 29672 | United States |
| Greenville Health System | Spartanburg | South Carolina | 29307 | United States |
| Tennessee Oncology, PLLC | Dickson | Tennessee | 37055 | United States |
| Tennessee Oncology, PLLC | Franklin | Tennessee | 37067 | United States |
| Tennessee Oncology, PLLC | Gallatin | Tennessee | 37066 | United States |
| Tennessee Oncology, PLLC | Hermitage | Tennessee | 37076 | United States |
| Tennessee Oncology, PLLC | Lebanon | Tennessee | 37087 | United States |
| Tennessee Oncology, PLLC | Lebanon | Tennessee | 37090 | United States |
| The West Clinic, PC | Memphis | Tennessee | 38104 | United States |
| The West Clinic, PC | Memphis | Tennessee | 38120 | United States |
| Tennessee Oncology, PLLC | Murfreesboro | Tennessee | 37129 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | United States |
| The Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Vanderbilt Breast Center at One Hundred Oaks | Nashville | Tennessee | 37204 | United States |
| Vanderbilt Health Pharmacy One Hundred Oaks | Nashville | Tennessee | 37204 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37205 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37207 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37211 | United States |
| Henry-Joyce Cancer Clinic | Nashville | Tennessee | 37232 | United States |
| Tennessee Oncology, PLLC | Smyrna | Tennessee | 37167 | United States |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Texas Oncology - Memorial City | Houston | Texas | 77024 | United States |
| Texas Oncology - Longview Cancer Center | Longview | Texas | 75601 | United States |
| Texas Oncology-Tyler | Tyler | Texas | 75702 | United States |
| Virginia Cancer Institute | Mechanicsville | Virginia | 23116-1844 | United States |
| Virginia Cancer Institute | Midlothian | Virginia | 23114 | United States |
| Virginia Oncology Associates | Newport News | Virginia | 23606 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23230 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23235-4730 | United States |
| Virginia Oncology Associates | Virginia Beach | Virginia | 23456 | United States |
| UZA | Edegem | Antwerpen | 2650 | Belgium |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| British Columbia Cancer Agency - Vancouver Centre | Vancouver | British Columbia | V5Z 4E6 | Canada |
| Sunnybrook Research Institute | Toronto | Ontario | M4N 3M5 | Canada |
| McGill University Health Centre-Cedars Cancer Centre | Montreal | Quebec | H4A 3J1 | Canada |
| Department of Radiology | Dooradoyle | Limerick | Ireland |
| 3rd Floor,Oncology Link office | Dublin | 4 | Ireland |
| Department of Radiology | Dublin | 4 | Ireland |
| Institute for Cancer Research | Dublin | 7 | Ireland |
| Mater Private Hospital | Dublin | 7 | Ireland |
| Pharmacy Department | Dublin | 7 | Ireland |
| Radiology Department | Dublin | 7 | Ireland |
| Pharmacy Department | Dublin | Ireland |
| Cancer Clinical Trials Unit, Mid-Western Cancer center | Limerick | Ireland |
| Pharmacy Department | Limerick | Ireland |
| Dipartimento di Oncologia Medica, IRCCS Ospedale San Raffaele | Milan | 20132 | Italy |
| Farmacia (magazzino ricevimento merc), IRCCS Ospedale San Raffaele | Milan | 20132 | Italy |
| U.O Farmaceutica, Nuovo Ospedale di Prato Palazzina dei servizi | Prato | 59100 | Italy |
| U.O. Oncologia Medica, Nuovo Ospedale di Prato | Prato | 59100 | Italy |
| Hospital Universitario HM Monteprincipe | Boadilla del Monte | Madrid | 28660 | Spain |
| Grupo Hospitalario Quiron - Hospital Quiron Barcelona | Barcelona | 08023 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Universitario Ramon Y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 Octubre | Madrid | 28041 | Spain |
| Centro Intergral Oncologico Clara Campal | Madrid | 28050 | Spain |
| Hospital de Madrid Norte-Sanchinarro. | Madrid | 28050 | Spain |
| Clinical Investigation and Research Unit | Brighton | England | BN2 5BE | United Kingdom |
| Pharmacy Department | Brighton | England | BN2 5BE | United Kingdom |
| Radiation Safety Service, Medical Physics Department | Brighton | England | BN2 5BE | United Kingdom |
| Histopathology Department | Nottingham | England | NG5 1PB | United Kingdom |
| Nottingham University Hospital | Nottingham | England | NG5 1PB | United Kingdom |
| Pharmacy Department | Nottingham | England | NG5 1PB | United Kingdom |
| Radiology Department | Nottingham | England | NG5 1PB | United Kingdom |
| Radiology Department | Nottingham | England | NG7 2UH | United Kingdom |
| Department of Radiology | Truro | England | TR1 3LJ | United Kingdom |
| Pharmacy Department | Truro | England | TR1 3LJ | United Kingdom |
| Royal Cornwall Hospitals NHS trust | Truro, Cornwall | England | TR1 3LJ | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) population included all enrolled participants who had positive androgen receptor (AR+) breast cancer as assessed by central review and received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Enzalutamide | Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause. |
| 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 |
|
| 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 | Percentage of Participants With Clinical Benefit at Week 16: Evaluable Population | Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of complete response (CR), partial response(PR), stable disease(SD) for >=16 weeks on radiologic imaging based on Investigator assessment using Response Evaluation Criteria in Solid Tumors version 1.1(RECIST 1.1). An estimate of the percentage and its exact 2-sided 85% confidence interval(CI) were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10mm short axis. PR: At least 30% decrease in sum of longest diameter (LD) of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference. | Evaluable population included all enrolled participants who had centrally assessed AR + breast cancer (total nuclear AR expression in >= 10% of tumor cells), had at least 1 dose of study drug and had at least 1 available post baseline tumor assessment evaluable as per RECIST 1.1. | Posted | Number | 85% Confidence Interval | Percentage of participants | Week 16 |
|
|
| |||||||||||||||||||||||||
| Primary | Percentage of Participants With Clinical Benefit at Week 16: Intent-to-Treat (ITT) Population | Percentage of participants with a clinical benefit at Week 16 defined as percentage of participants with a best response of CR, PR, or SD for >= 16 weeks on radiologic imaging based on Investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference. | ITT population included all enrolled participants who had centrally assessed AR+ breast cancer and received at least 1 dose of study drug. | Posted | Number | 85% Confidence Interval | Percentage of participants | Week 16 |
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| Secondary | Percentage of Participants With Clinical Benefit at Week 24: Evaluable Population | Percentage of participants with a clinical benefit at Week 24 defined as percentage of participants with a best response of CR, PR, or SD for >= 24 weeks on radiologic imaging based on investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference. | Evaluable population included all enrolled participants who had centrally assessed AR + breast cancer (total nuclear AR expression in >= 10% of tumor cells), had at least 1 dose of study drug and had at least 1 available post baseline tumor assessment evaluable as per RECIST 1.1. | Posted | Number | 85% Confidence Interval | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With Clinical Benefit at Week 24: ITT Population | Percentage of participants with a clinical benefit at Week 24 defined as percentage of participants with a best response of CR, PR, or SD for >= 24 weeks on radiologic imaging based on investigator assessment using RECIST 1.1. An estimate of the percentage and its exact 2-sided 85% CI were calculated using the Blaker method. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in size <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. SD: Neither sufficient reduction to qualify as PR nor sufficient increase to qualify as PD, using the smallest sum diameters during the study as a reference. | ITT population included all enrolled participants who had centrally assessed AR+ breast cancer and received at least 1 dose of study drug. | Posted | Number | 85% Confidence Interval | Percentage of participants | Week 24 |
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| Secondary | Percentage of Participants With Best Objective Response: Evaluable Population | Percentage of participants with best objective response defined as percentage of participants with a best response of CR and PR based on investigator assessment of target, non-target and new lesions using RECIST 1.1. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. | Evaluable population included all enrolled participants who had centrally assessed AR + breast cancer (total nuclear AR expression in >= 10% of tumor cells), had at least 1 dose of study drug and had at least 1 available post baseline tumor assessment evaluable as per RECIST 1.1. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Number | 85% Confidence Interval | Percentage of participants | From Baseline up to disease progression or death due to any cause (up to 87 Weeks) |
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| Secondary | Percentage of Participants With Best Objective Response: ITT Population | Percentage of participants with best objective response defined as percentage of participants with a best response of CR and PR based on investigator assessment of target, non-target and new lesions using RECIST 1.1. As per RECIST 1.1, CR defined as disappearance of all target, non-target lesions and normalization of tumor marker level and all lymph nodes decreased to non-pathological in <10 mm short axis. PR: At least 30% decrease in sum of LD of target lesions taking as reference baseline sum of LD, without progression of non-target lesions, no appearance of new lesions. | ITT population included all enrolled participants who had centrally assessed AR+ breast cancer and received at least 1 dose of study drug. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Number | 85% Confidence Interval | Percentage of participants | From Baseline up to disease progression or death due to any cause (up to 87 Weeks) |
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| Secondary | Progression-Free Survival (PFS): Evaluable Population | PFS was defined as the time (in weeks) from the date of first dose of study drug to the date of documented disease progression or death due to any cause whichever occurs first as determined by the investigator using RECIST 1.1. As per RECIST 1.1, progression was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. | Evaluable population included all enrolled participants who had centrally assessed AR + breast cancer (total nuclear AR expression in >= 10% of tumor cells), had at least 1 dose of study drug and had at least 1 available post baseline tumor assessment evaluable as per RECIST 1.1. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | 85% Confidence Interval | Weeks | From Baseline up to disease progression or death due to any cause (up to 87 Weeks) |
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| Secondary | Progression-Free Survival: ITT Population | PFS was defined as the time (in weeks) from the date of first dose of study drug to the date of documented disease progression or death due to any cause whichever occurs first as determined by the investigator using RECIST 1.1. As per RECIST 1.1, progression was defined as: >=20 percent increase in sum of LD of target lesions taking as a reference the smallest sum of the LD recorded since the treatment started, or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions. | ITT population included all enrolled participants who had centrally assessed AR+ breast cancer and received at least 1 dose of study drug. | Posted | Median | 85% Confidence Interval | Weeks | From Baseline up to disease progression or death due to any cause (up to 87 Weeks) |
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| Other Pre-specified | Trough Plasma Concentration of Enzalutamide and Its Metabolite | M2 was the metabolite of enzalutamide. The lower limit of quantitation (LLQ) was 0.0200 micrograms per milliliter (mcg/mL) for enzalutamide and M2. | Pharmacokinetics (PK) analysis population included all participants who received 1 dose or partial dose of study drug, and who had at least 1 enzalutamide or M2 plasma concentration assessment. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | Predose on Day 1 (Baseline), Week 9 and Week 17 |
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| Other Pre-specified | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment emergent are events that were absent before treatment or that worsened relative to pretreatment state between first dose of study drug and up to 30 days after last dose of study drug or the day prior to initiation of new anti-tumor treatment. AEs included both serious and non-serious AEs. | Safety population included all participants who received 1 dose or partial dose of study drug. | Posted | Count of Participants | Participants | Baseline up to 87 weeks |
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| Other Pre-specified | Number of Participants With Study Drug Discontinuation Due to Adverse Events | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Data reported here is for study drug discontinuation due to adverse events. | Safety population included all participants who received 1 dose or partial dose of study drug. | Posted | Count of Participants | Participants | Baseline up to 87 weeks |
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| Other Pre-specified | Number of Participants With Grade 3 or Higher Adverse Events | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Severity of the AEs was graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. As per the NCI CTCAE, version 4.0, Grade 3= severe, Grade 4= life-threatening and Grade 5= death. Only the participants with treatment-emergent AEs of Grade 3 (severe) or higher grade were reported in this outcome measure. | Safety population included all participants who received 1 dose or partial dose of study drug. | Posted | Count of Participants | Participants | Baseline up to 87 weeks |
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| Other Pre-specified | Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Criteria: Systolic blood pressure (SBP):absolute SBP<90 millimeters of mercury (mmHg) and decrease from baseline (DFB)>30mmHg, absolute SBP>180mmHg and increase from baseline (IFB)>40 mmHg, final visit (FV) or 2 consecutive visits (CV) SBP>=20 mmHg change from baseline (CFB), most extreme post-baseline SBP>=140mmHg, most extreme post- baseline SBP>=180mmHg, most extreme SBP>=140mmHg and>=20 mmHg CFB, most extreme SBP>=180mmHg and>=20mmHg CFB; diastolic blood pressure (DBP): absolute DBP>105mmHg and IFB>30mmHg, absolute DBP<50mmHg and DFB>20mmHg, final visit or 2 consecutive visits DBP>=15mmHg CFB, most extreme post-baseline DBP>=90mmHg, most extreme post-baseline DBP>=105mmHg, most extreme DBP>=90mmHg and>=15mmHg CFB, most extreme DBP>=105mmHg and>=15mmHg CFB; heart rate<50beats per minute (BPM) and DFB>20BPM or heart rate>120BPM and IFB>30BPM. Only those categories, in which at least 1 participant had data were reported. | Safety population included all participants who received 1 dose or partial dose of study drug. | Posted | Count of Participants | Participants | From start of study treatment on Day 1 up to 30 days after the last dose of study drug (up to maximum of 9.6 years) |
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| Other Pre-specified | Number of Participants With Change From Baseline in Laboratory Parameters Grades by 2 or More Grades | Laboratory tests included hematology parameters [low lymphocytes (10^6/L), white blood cells (10^9/L), neutrophils (10^6/L), hemoglobin gram per Liter(g/L) and platelets (10^9/L)] and chemistry parameters [mean albumin grams per Liter(g/L), calcium milli mole per Liter(mmol/L), Phosphate (mmol/L), alanine aminotransferase units per Liter(U/L), Aspartate aminotransferase (U/L), bilirubin micro mole per Liter, Alkaline phosphatase (U/L) and glucose (mmol/L)]. Number of participants with change from baseline in laboratory parameters Grades by 2 or More Grades as per NCI-CTCAE (version 4.0) (Grade 2=Moderate, Grade 3= Severe, Grade 4= Life-threatening) were reported. | Safety population included all participants who received 1 dose or partial dose of study drug. | Posted | Count of Participants | Participants | From start of study treatment on Day 1 up to 30 days after the last dose of study drug (up to maximum of 9.6 years) |
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| Secondary | Time to Response: Evaluable Population | The time to response is defined as the time from the date of first dose of study drug to initial CR or PR. Participants without response of CR or PR before the data cutoff date were censored at the last tumor assessment date before the data cutoff. Kaplan-Meier method was used to summarize time to response. | Evaluable population included all enrolled participants who had centrally assessed AR + breast cancer (total nuclear AR expression in >= 10% of tumor cells), had at least 1 dose of study drug and had at least 1 available post baseline tumor assessment evaluable as per RECIST 1.1. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Weeks | From first dose of study drug until first documentation of CR or PR or data censoring date, whichever occurred first (up to 87 Weeks) |
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| Secondary | Duration of Response: Evaluable Population | Duration of objective response is defined as the time from initial CR or PR to documented disease progression or death due to any cause, whichever occurs first. Participants without disease progression or death due to any cause before the data cutoff date were censored at the last tumor assessment date before the data cutoff. | Evaluable population included all enrolled participants who had centrally assessed AR + breast cancer (total nuclear AR expression in >= 10% of tumor cells), had at least 1 dose of study drug and had at least 1 available post baseline tumor assessment evaluable as per RECIST 1.1. Here, 'Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | 95% Confidence Interval | Weeks | From first documentation of CR or PR until first documentation of tumor progression or death due to any cause or data censoring date, whichever occurred first (up to 87 Weeks) |
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| Secondary | Number of Participants With Postbaseline Laboratory Toxicities Grade 3 or 4 | Laboratory parameters included hematology parameters [low lymphocytes (10^6/L), neutrophils (10^6/L) and Leukocytes (10^9/L)] and chemistry parameters [high phosphate (mmol/L), bilirubin, Alkaline phosphatase (U/L) and glucose (mmol/L)]. Number of participants with postbaseline laboratory toxicity Grade 3 or 4 as per NCI-CTCAE (version 4.0) (Grade 3= Severe, Grade 4= Life-threatening) were reported. | Safety population included all participants who received 1 dose or partial dose of study drug. | Posted | Count of Participants | Participants | From start of study treatment on Day 1 up to 30 days after the last dose of study drug (up to maximum of 9.6 years) |
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|
Baseline up to 87 weeks
Same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study. AEs and SAEs were collected for safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enzalutamide | Participants received enzalutamide 160 mg (as four 40 mg soft gelatin capsules), orally once daily until disease progression, intolerable AEs (including any seizures), non-compliance with protocol requirements, initiation of a new anti-tumor treatment, or participant or physician decision to discontinue treatment or death due to any cause. | 88 | 118 | 29 | 118 | 106 | 118 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericardial effusion | Cardiac disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Bile duct obstruction | Hepatobiliary disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v16.1 | Non-systematic Assessment |
| |
| Radiation oesophagitis | Injury, poisoning and procedural complications | MedDRA v16.1 | Non-systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA v16.1 | Non-systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA v16.1 | Non-systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Malignant pleural effusion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v16.1 | Non-systematic Assessment |
| |
| Metastatic pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v16.1 | Non-systematic Assessment |
| |
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v16.1 | Non-systematic Assessment |
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| Pericardial effusion malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v16.1 | Non-systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v16.1 | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v16.1 | Non-systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v16.1 | Non-systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v16.1 | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v16.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v16.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v16.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C540278 | enzalutamide |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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