Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-02 @ 12:06 PM
Study NCT ID:
NCT04735367
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2021-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C500026', 'term': 'palbociclib'}, {'id': 'D000077289', 'term': 'Letrozole'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, '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 publication 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': 'For all-cause mortality: From start of subsequent treatment in study A5481010 until date of death, withdrawal of consent or end of study (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in study A5481154. Data for non-serious adverse events and serious adverse events (SAEs) were not collected and evaluated during the study; hence timeframe is not applicable for non-SAEs and SAEs.', 'description': 'This observational retrospective study retrieved data from medical records and the data existed as unstructured data. In these data sources, individual participant data were not retrieved or validated. Hence adverse events were not assessed/collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Palbociclib+ Letrozole', 'description': 'Participants with HR+/HER2- advanced breast cancer who were treated with palbociclib plus letrozole in study A5481010 (NCT01684215).', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 20, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib+ Letrozole', 'description': 'Participants with HR+/HER2- advanced breast cancer who were treated with palbociclib plus letrozole in study A5481010 (NCT01684215).'}], 'classes': [{'categories': [{'measurements': [{'value': '85.42', 'comment': 'Upper limit of 95% confidence interval (CI) could not be estimated because of insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '64.26', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the date of the first dose of the treatment in study A5481010 to the date of any-cause death or censoring date (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study', 'description': 'OS was defined as the time from the date of the first dose of the investigational product in Japanese Phase 2 study (A5481010) to the date of any-cause death. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. Kaplan-Meier method was used for analysis.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set included participants who were enrolled in J-Ph2 and received the investigational product excluding surviving participants who did not give written or oral consent.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants According to Types and Line of Subsequent Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib+ Letrozole', 'description': 'Participants with HR+/HER2- advanced breast cancer who were treated with palbociclib plus letrozole in study A5481010 (NCT01684215).'}], 'classes': [{'title': 'Received First Subsequent Therapy', 'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000'}]}]}, {'title': 'First Subsequent Therapy: Endocrine-based therapy', 'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000'}]}]}, {'title': 'First Subsequent Therapy: Endocrine therapy + Chemotherapy', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'First Subsequent Therapy: Chemotherapy', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}]}]}, {'title': 'First Subsequent Therapy: Other', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}]}]}, {'title': 'Received Second Subsequent Therapy', 'categories': [{'measurements': [{'value': '69.0', 'groupId': 'OG000'}]}]}, {'title': 'Second Subsequent Therapy: Endocrine-based therapy', 'categories': [{'measurements': [{'value': '40.5', 'groupId': 'OG000'}]}]}, {'title': 'Second Subsequent Therapy: Endocrine therapy + Chemotherapy', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'Second Subsequent Therapy: Chemotherapy', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000'}]}]}, {'title': 'Second Subsequent Therapy: Other', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From start of subsequent treatment in study A5481010 until date of death, withdrawal of consent or end of study (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study', 'description': 'Participants were classified based on types of subsequent treatment and by line of subsequent treatment. Subsequent treatments included: endocrine therapy-based, chemotherapy-based and others (Investigational drug + Endocrine therapy/Chemotherapy).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set included participants who were enrolled in J-Ph2 and received the investigational product excluding surviving participants who did not give written or oral consent.'}, {'type': 'SECONDARY', 'title': 'Duration of Subsequent Therapy by Line of Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Palbociclib+ Letrozole', 'description': 'Participants with HR+/HER2- advanced breast cancer who were treated with palbociclib plus letrozole in study A5481010 (NCT01684215).'}], 'classes': [{'title': 'First Subsequent Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.64', 'groupId': 'OG000', 'lowerLimit': '3.91', 'upperLimit': '9.00'}]}]}, {'title': 'Second Subsequent Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.01', 'groupId': 'OG000', 'lowerLimit': '3.25', 'upperLimit': '14.88'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From start of subsequent treatment in study A5481010 until date of death, withdrawal of consent or end of study (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study', 'description': 'Duration of subsequent therapy defined as time from the start date to the end date of each line of treatment among participants who received subsequent treatment. Kaplan-Meier method was used.', 'unitOfMeasure': 'Months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis set included participants who were enrolled in J-Ph2 and received the investigational product excluding surviving participants who did not give written or oral consent. All participants reported under "Number of Participants Analyzed" contributed data to the table; however, may not have evaluable data for every row. Here "Number Analyzed" refers to the number of participants evaluable for the specified rows.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Palbociclib+ Letrozole', 'description': 'Participants with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer who were treated with palbociclib plus letrozole in study A5481010 (NCT01684215).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Data was collected from participants who were treated with palbociclib plus letrozole in Japanese Phase 2 study A5481010 (NCT01684215). Data was collected retrospectively from individual participant medical records for participants under survival follow up at the time of completion of study A5481010 and for participants who died or refused follow-up in study A5481010, data collected in Phase 2 study was used for analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Palbociclib+ Letrozole', 'description': 'Participants with HR+/HER2- advanced breast cancer who were treated with palbociclib plus letrozole in study A5481010 (NCT01684215).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Analysis set included participants who were enrolled in Japanese Phase 2 (J-Ph2) study and received the investigational product, excluding surviving participants who did not give written or oral consent.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-07', 'size': 1758338, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-09-26T12:47', 'hasProtocol': True}, {'date': '2023-09-09', 'size': 134986, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-09-26T12:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-22', 'studyFirstSubmitDate': '2021-01-28', 'resultsFirstSubmitDate': '2024-09-26', 'studyFirstSubmitQcDate': '2021-01-28', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-22', 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival (OS)', 'timeFrame': 'From the date of the first dose of the treatment in study A5481010 to the date of any-cause death or censoring date (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study', 'description': 'OS was defined as the time from the date of the first dose of the investigational product in Japanese Phase 2 study (A5481010) to the date of any-cause death. In the absence of confirmation of death, survival time was censored to last date the participant was known to be alive. Kaplan-Meier method was used for analysis.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants According to Types and Line of Subsequent Treatment', 'timeFrame': 'From start of subsequent treatment in study A5481010 until date of death, withdrawal of consent or end of study (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study', 'description': 'Participants were classified based on types of subsequent treatment and by line of subsequent treatment. Subsequent treatments included: endocrine therapy-based, chemotherapy-based and others (Investigational drug + Endocrine therapy/Chemotherapy).'}, {'measure': 'Duration of Subsequent Therapy by Line of Therapy', 'timeFrame': 'From start of subsequent treatment in study A5481010 until date of death, withdrawal of consent or end of study (maximum of 103.16 months of follow-up); data collected and observed retrospectively over 32 months in A5481154 study', 'description': 'Duration of subsequent therapy defined as time from the start date to the end date of each line of treatment among participants who received subsequent treatment. Kaplan-Meier method was used.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['retrospective', 'multicenter', 'observational study', 'Japan', 'HR+/HER2- advanced breast cancer', 'palbociclib', 'overall survival'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '40841781', 'type': 'DERIVED', 'citation': 'Takahashi M, Yasojima H, Osako T, Inoue K, Kawashima M, Maeda H, Ito M, Sagara Y, Yonemori K, Hattori M, Yamamoto N, Muramatsu Y, Matsui A, Masuda N. Overall survival and subsequent therapy patterns in Japanese patients with ER+/HER2- advanced breast cancer treated with palbociclib plus letrozole in the first-line setting: a final analysis. Breast Cancer. 2025 Nov;32(6):1482-1490. doi: 10.1007/s12282-025-01760-0. Epub 2025 Aug 21.'}, {'pmid': '37882974', 'type': 'DERIVED', 'citation': 'Takahashi M, Osako T, Yasojima H, Inoue K, Kawashima M, Maeda H, Ichikawa A, Muramatsu Y, Masuda N. Overall survival in Japanese patients with ER+/HER2- advanced breast cancer treated with first-line palbociclib plus letrozole. Breast Cancer. 2024 Jan;31(1):53-62. doi: 10.1007/s12282-023-01511-z. Epub 2023 Oct 26.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=A5481154', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a retrospective, multicenter, observational study in Japan. The primary objective is to evaluate overall survival (OS) in Japanese patients with HR+/HER2- advanced breast cancer who have been treated with palbociclib plus letrozole. This observational study was planned as follow-up study of Japanese phase 2 study of palbociclib (NCT01684215, phase 2 portion of A5481010 study).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who participated, treated with palbociclib plus letrozole, and under follow-up for survival in J-Ph2', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participated, treated with palbociclib plus letrozole in J-Ph2, and was under follow-up for survival at the study completion of J-Ph2.\n2. For patients who are still alive and have routine visits to the study site, evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study. For patients who are still alive and had been transferred to another hospital, evidence that the patient has been informed of all pertinent aspects of the study and oral or written informed consent is obtained. For patients who had already passed away, the conduct of this study will be disclosed, and the patients' legally acceptable representatives will be guaranteed an opportunity to refuse data collection for the patients in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects\n\nExclusion Criteria:\n\n1\\. There are no exclusion criteria for this study."}, 'identificationModule': {'nctId': 'NCT04735367', 'briefTitle': 'Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'Retrospective, Multicenter, Observational Study to Evaluate Overall Survival in Japanese Patients With HR+/HER2- Advanced Breast Cancer Treated With Palbociclib Plus Letrozole', 'orgStudyIdInfo': {'id': 'A5481154'}, 'secondaryIdInfos': [{'id': 'NCT04735367', 'type': 'REGISTRY', 'domain': 'ClinicalTrials.gov'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'palbociclib plus letrozole', 'type': 'DRUG', 'description': 'palbociclib plus letrozole'}]}, 'contactsLocationsModule': {'locations': [{'zip': '260-8717', 'city': 'Chiba', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Chiba cancer center', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '791-0280', 'city': 'Matsuyama', 'state': 'Ehime', 'country': 'Japan', 'facility': 'National Hospital Organization Shikoku Cancer Center', 'geoPoint': {'lat': 33.83916, 'lon': 132.76574}}, {'zip': '730-8518', 'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Hiroshima City Hiroshima Citizens Hospital', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'zip': '003-0804', 'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'National Hospital Organization Hokkaido Cancer Center', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'zip': '860-8556', 'city': 'Kumamoto', 'state': 'Kumamoto', 'country': 'Japan', 'facility': 'Kumamoto University Hospital', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '362-0806', 'city': 'Kita-adachi-gun', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Saitama Cancer Center'}, {'zip': '104-0045', 'city': 'Chuo-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'National Cancer Center Hospital'}, {'zip': '811-1395', 'city': 'Fukuoka', 'country': 'Japan', 'facility': 'National Hospital Organization Kyushu Cancer Center', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'zip': '892-0833', 'city': 'Kagoshima', 'country': 'Japan', 'facility': 'Hakuaikai Medical Corporation Sagara Hospital', 'geoPoint': {'lat': 31.56667, 'lon': 130.55}}, {'zip': '862-8655', 'city': 'Kumamoto', 'country': 'Japan', 'facility': 'Kumamoto Shinto General Hospital', 'geoPoint': {'lat': 32.80589, 'lon': 130.69181}}, {'zip': '606-8507', 'city': 'Kyoto', 'country': 'Japan', 'facility': 'Kyoto University Hospital', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'zip': '464-8681', 'city': 'Nagoya', 'country': 'Japan', 'facility': 'Aichi Cancer Center', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '540-0006', 'city': 'Osaka', 'country': 'Japan', 'facility': 'National Hospital Organization - Osaka National Hospital - Institute For Clinical Research', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], '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'}}}}