Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-21 @ 11:27 AM
Study NCT ID:
NCT03159195
Status:
COMPLETED
Last Update Posted:
2025-07-01
First Post:
2017-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Ibrance Real World Insights
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Not applicable as safety data was not planned to be collected for the study', 'description': 'Due to non-interventional nature of the study, safety data was not collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Palbociclib + Aromatase Inhibitor (P+AI)', 'description': 'Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Palbociclib + Fulvestrant (P+FV)', 'description': 'Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Progression Free Survival (PFS) at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor (P+AI)', 'description': 'Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant (P+FV)', 'description': 'Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.1', 'groupId': 'OG000'}, {'value': '79.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of palbociclib combination treatment up to Month 12 (data recorded during 4 years of retrospective observation period)', 'description': 'PFS was defined as the time from palbociclib combination treatment initiation until 1) clinician documented disease progression (PD) while on palbociclib, 2) death, 3) start of a new therapy line after final palbociclib dose, if the reason for discontinuation of palbociclib was disease progression, or 4) last available follow-up, whichever occurred first. Participants who did not experience a progression event (items 1, 2 and 3) were censored at date of last available follow-up. PFS (in months) was calculated as (first event date - palbociclib initiation date + 1)/30.4. Progressive disease - An increase in visible disease and/or presence of any new lesions; included cases where the clinician indicated progressive disease. Percentage of participants with PFS events at 12 months based on the Kaplan-Meier estimate were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included participants aged \\>=18 years, diagnosed with HR+/HER- breast cancer with confirmed ABC/MBC, received palbociclib + letrozole/AI or palbociclib + fulvestrant in line with the licensed indication, had no prior or current enrolment in an interventional clinical trial for ABC/MBC, had minimum of 3 months of follow up data since palbociclib with fulvestrant initiation, or minimum of 6 months of follow up data since palbociclib with letrozole/AI initiation.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Progression Free Survival at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor (P+AI)', 'description': 'Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.'}], 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 of palbociclib combination treatment up to Month 24 (data recorded during 4 years of retrospective observation period)', 'description': 'PFS was defined as the time from palbociclib combination treatment initiation until 1) clinician documented disease progression (PD) while on palbociclib, 2) death, 3) start of a new therapy line after final palbociclib dose, if the reason for discontinuation of palbociclib was disease progression, or 4) last available follow-up, whichever occurred first. Participants who did not experience a progression event (items 1, 2 and 3) were censored at date of last available follow-up. PFS (in months) was calculated as (first event date - palbociclib initiation date + 1)/30.4. Progressive disease - An increase in visible disease and/or presence of any new lesions; included cases where the clinician indicated progressive disease. Percentage of participants with PFS events at 24 months based on the Kaplan-Meier estimate were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population was analyzed for this outcome measure. Data for this outcome measure for reporting group ''P+FV'' was not collected due to limited time on treatment for participants in this group, data was not available beyond Month 12."}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Objective Response Rate (ORR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor (P+AI)', 'description': 'Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant (P+FV)', 'description': 'Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.5', 'groupId': 'OG000'}, {'value': '74.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)', 'description': 'ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) on palbociclib combination therapy according to the RECIST version 1.1 recorded from first dose of study treatment until disease progression due to any cause. 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Percentage of participants who alive after 1 year post Palbociclib treatment initiation were based on the Kaplan-Meier estimate.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS:participants aged \\>=18 years, diagnosed with HR+/HER- breast cancer with confirmed ABC/MBC, received P + letrozole/AI or P + FV in line with licensed indication, had no prior or current enrolment in an interventional clinical trial for ABC/MBC, had minimum of 3 months of follow up data since P with FV initiation, or minimum of 6 months of follow up data since P with letrozole/AI initiation. "Overall Number of Participants Analyzed"=participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Alive After 2 Years Post Palbociclib Treatment Initiation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '354', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor (P+AI)', 'description': 'Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 years (Month 24) post Palbociclib treatment initiation (data recorded during 4 years of retrospective observation period)', 'description': 'Percentage of participants alive from date of initiation of palbociclib treatment through up to 2 or above progression-based lines of therapy were recorded and reported in this outcome measure. Percentage of participants who alive after 2 years post Palbociclib treatment initiation were based on the Kaplan-Meier estimate.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population was analyzed for this outcome measure. Data for this outcome measure for reporting group \'\'P+FV\'\' was not collected due to limited time on treatment for participants in this group, data was not available beyond Month 12. Here, "Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Clinical Benefit Rate (CBR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib + Aromatase Inhibitor (P+AI)', 'description': 'Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.'}, {'id': 'OG001', 'title': 'Palbociclib + Fulvestrant (P+FV)', 'description': 'Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000'}, {'value': '93.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)', 'description': "CBR was defined as the percentage of participants who achieved complete (where 'complete response' was recorded at any time on treatment) or partial response (where 'partial response' was recorded at any time on treatment), or stable disease at greater than equal to (\\>=) 24 weeks on palbociclib combination therapy. Stable disease was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Complete response - Complete resolution of all visible disease. 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Stable disease was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population was analyzed. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Palbociclib + Aromatase Inhibitor (AI) (P+AI)', 'description': 'Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.'}, {'id': 'FG001', 'title': 'Palbociclib + Fulvestrant (P+FV)', 'description': 'Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '360'}, {'groupId': 'FG001', 'numSubjects': '292'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '360'}, {'groupId': 'FG001', 'numSubjects': '292'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants who received palbociclib plus aromatase inhibitor (P + AI) or palbociclib plus fulvestrant (P + FV) as treatment of hormone receptor positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (ABC/MBC) in April 2017 or later, were observed retrospectively for treatment patterns and clinical outcomes.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '360', 'groupId': 'BG000'}, {'value': '292', 'groupId': 'BG001'}, {'value': '652', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Palbociclib + Aromatase Inhibitor (P+AI)', 'description': 'Participants who received palbociclib along with AI for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.'}, {'id': 'BG001', 'title': 'Palbociclib + Fulvestrant (P+FV)', 'description': 'Participants who received palbociclib along with FV for the treatment of ABC/MBC as part of their routine treatment were observed retrospectively for a period of 4 years, approximately.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.8', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '63.0', 'spread': '11.4', 'groupId': 'BG001'}, {'value': '64.0', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '360', 'groupId': 'BG000'}, {'value': '292', 'groupId': 'BG001'}, {'value': '652', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race and Ethnicity', 'categories': [{'title': 'White/Caucasian', 'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '391', 'groupId': 'BG002'}]}, {'title': 'African American', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Hispanic/Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full analysis set (FAS) population included participants aged \\>=18 years, diagnosed with HR+/HER- breast cancer with confirmed ABC/MBC, received palbociclib + letrozole/AI or palbociclib + fulvestrant in line with the licensed indication, had no prior or current enrolment in an interventional clinical trial for ABC/MBC, had minimum of 3 months of follow up data since palbociclib with fulvestrant initiation, or minimum of 6 months of follow up data since palbociclib with letrozole/AI initiation.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-25', 'size': 2461194, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-23T12:42', 'hasProtocol': True}, {'date': '2019-10-04', 'size': 2171777, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-23T12:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 652}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2021-06-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-23', 'studyFirstSubmitDate': '2017-05-17', 'resultsFirstSubmitDate': '2021-07-23', 'studyFirstSubmitQcDate': '2017-05-17', 'lastUpdatePostDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-23', 'studyFirstPostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Clinical Benefit Rate (CBR)', 'timeFrame': 'From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)', 'description': "CBR was defined as the percentage of participants who achieved complete (where 'complete response' was recorded at any time on treatment) or partial response (where 'partial response' was recorded at any time on treatment), or stable disease at greater than equal to (\\>=) 24 weeks on palbociclib combination therapy. Stable disease was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Complete response - Complete resolution of all visible disease. Partial response - Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease."}, {'measure': 'Percentage of Participants With Best Overall Response', 'timeFrame': 'From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)', 'description': "Best overall response was defined as the percentage of participants who achieved complete (where 'complete response' was recorded at any time on treatment), partial response (where 'partial response' was recorded at any time on treatment) and stable disease at greater than equal to (\\>=) 24 weeks on palbociclib combination therapy. Stable disease was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater."}], 'primaryOutcomes': [{'measure': 'Percentage of Participants With Progression Free Survival (PFS) at Month 12', 'timeFrame': 'Day 1 of palbociclib combination treatment up to Month 12 (data recorded during 4 years of retrospective observation period)', 'description': 'PFS was defined as the time from palbociclib combination treatment initiation until 1) clinician documented disease progression (PD) while on palbociclib, 2) death, 3) start of a new therapy line after final palbociclib dose, if the reason for discontinuation of palbociclib was disease progression, or 4) last available follow-up, whichever occurred first. Participants who did not experience a progression event (items 1, 2 and 3) were censored at date of last available follow-up. PFS (in months) was calculated as (first event date - palbociclib initiation date + 1)/30.4. Progressive disease - An increase in visible disease and/or presence of any new lesions; included cases where the clinician indicated progressive disease. Percentage of participants with PFS events at 12 months based on the Kaplan-Meier estimate were reported.'}, {'measure': 'Percentage of Participants With Progression Free Survival at Month 24', 'timeFrame': 'Day 1 of palbociclib combination treatment up to Month 24 (data recorded during 4 years of retrospective observation period)', 'description': 'PFS was defined as the time from palbociclib combination treatment initiation until 1) clinician documented disease progression (PD) while on palbociclib, 2) death, 3) start of a new therapy line after final palbociclib dose, if the reason for discontinuation of palbociclib was disease progression, or 4) last available follow-up, whichever occurred first. Participants who did not experience a progression event (items 1, 2 and 3) were censored at date of last available follow-up. PFS (in months) was calculated as (first event date - palbociclib initiation date + 1)/30.4. Progressive disease - An increase in visible disease and/or presence of any new lesions; included cases where the clinician indicated progressive disease. Percentage of participants with PFS events at 24 months based on the Kaplan-Meier estimate were reported.'}, {'measure': 'Percentage of Participants With Objective Response Rate (ORR)', 'timeFrame': 'From initiation of treatment up to disease progression (data recorded during 4 years of retrospective observation period)', 'description': 'ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) on palbociclib combination therapy according to the RECIST version 1.1 recorded from first dose of study treatment until disease progression due to any cause. Complete response: complete resolution of all visible disease. Partial response: partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.'}, {'measure': 'Percentage of Participants Alive After 1 Year Post Palbociclib Treatment Initiation', 'timeFrame': '1 Year (Month 12) post Palbociclib treatment initiation (data recorded during 4 years of retrospective observation period)', 'description': 'Percentage of participants alive from date of initiation of palbociclib treatment through up to 2 or above progression-based lines of therapy were recorded and reported in this outcome measure. Percentage of participants who alive after 1 year post Palbociclib treatment initiation were based on the Kaplan-Meier estimate.'}, {'measure': 'Percentage of Participants Alive After 2 Years Post Palbociclib Treatment Initiation', 'timeFrame': '2 years (Month 24) post Palbociclib treatment initiation (data recorded during 4 years of retrospective observation period)', 'description': 'Percentage of participants alive from date of initiation of palbociclib treatment through up to 2 or above progression-based lines of therapy were recorded and reported in this outcome measure. Percentage of participants who alive after 2 years post Palbociclib treatment initiation were based on the Kaplan-Meier estimate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['metastatic breast cancer', 'advanced breast cancer', 'HR+/ HER2-'], 'conditions': ['Malignant Neoplasm of Breast']}, 'referencesModule': {'references': [{'pmid': '35567914', 'type': 'DERIVED', 'citation': 'Mycock K, Zhan L, Hart K, Taylor-Stokes G, Milligan G, Atkinson C, Mitra D. Real-world treatment patterns and clinical outcomes in patients receiving palbociclib combinations for HR+/HER2- advanced/metastatic breast cancer in Japan: Results from the IRIS study. Cancer Treat Res Commun. 2022;32:100573. doi: 10.1016/j.ctarc.2022.100573. Epub 2022 May 6.'}, {'pmid': '33498797', 'type': 'DERIVED', 'citation': 'Mycock K, Zhan L, Taylor-Stokes G, Milligan G, Mitra D. Real-World Palbociclib Use in HR+/HER2- Advanced Breast Cancer in Canada: The IRIS Study. Curr Oncol. 2021 Jan 24;28(1):678-688. doi: 10.3390/curroncol28010066.'}, {'pmid': '31050919', 'type': 'DERIVED', 'citation': 'Waller J, Mitra D, Mycock K, Taylor-Stokes G, Milligan G, Zhan L, Iyer S. Real-World Treatment Patterns and Clinical Outcomes in Patients Receiving Palbociclib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced or Metastatic Breast Cancer in Argentina: The IRIS Study. J Glob Oncol. 2019 May;5:JGO1800239. doi: 10.1200/JGO.18.00239.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=A5481090', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To describe patient demographics, clinical characteristics, treatment patterns and clinical outcomes of adult female patients who have received palbociclib combination treatments in line with regional licensed indications in real world settings across multiple countries.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult female patients with HR+/HER2 advanced or metastatic breast cancer receiving palbociclib combination regimens as per the approved indication.', 'genderDescription': 'Female participants only', 'healthyVolunteers': False, 'eligibilityCriteria': 'Physician inclusion criteria\n\n* Oncologist or gynecologist\n* Responsible for treating a minimum of ≥2-6 (depending on country) ABC/MBC patients who meet the eligibility criteria.\n* Agrees to participate in the study and complete the eCRFs within the data collection period.\n\nPatient inclusion criteria\n\n* Female\n* ≥18 years old.\n* HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease.\n* Received palbociclib plus letrozole/aromatase inhibitor or palbociclib plus fulvestrant in line with the licenced indication(s).\n* No prior or current enrolment in an interventional clinical trial for ABC/MBC.\n* Minimum of three months of follow up data since palbociclib with fulvestrant initiation, or minimum of six months of follow up data since palbociclib with letrozole/aromatase inhibitor initiation (core medical record review).\n* Minimum of three months of follow up data since palbociclib initiation (German interim medical record review only).\n* Inoperable or recurrent breast cancer (Japan only)\n\nExclusion criteria:\n\nPhysician exclusion criteria\n\n* Qualified less than 2 years ago or more than 35 years ago\n* Participated in observational research for ABC/MBC in the last 3 months\n* Have not prescribed either palbociclib plus fulvestrant or palbociclib plus aromatase inhibitor in line with the licenced indication(s).'}, 'identificationModule': {'nctId': 'NCT03159195', 'acronym': 'IRIS', 'briefTitle': 'Ibrance Real World Insights', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'TREATMENT PATTERNS AND CLINICAL OUTCOMES AMONG PATIENTS RECEIVING PALBOCICLIB COMBINATIONS FOR HR+/HER2- ADVANCED/METASTATIC BREAST CANCER IN REAL WORLD SETTINGS', 'orgStudyIdInfo': {'id': 'A5481090'}, 'secondaryIdInfos': [{'id': 'IRIS', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Breast Cancer Patients', 'description': 'HR+/HER2- advanced/metastatic breast cancer patients across multiple countries.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10017', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer, Inc.', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "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."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}