Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-04-06 @ 5:36 AM
Study NCT ID:
NCT03285568
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2017-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patterns of Prescribing and Monitoring of Palbociclib
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2017-09-14', 'studyFirstSubmitQcDate': '2017-09-14', 'lastUpdatePostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Palbociclib dose according to the package insert recommendations.', 'timeFrame': '22 months', 'description': 'Identify the proportion of patients who were maintained on a palbociclib dose according to the package insert recommendations.'}], 'secondaryOutcomes': [{'measure': 'Dose adjustment for hematologic toxicities', 'timeFrame': '22 months', 'description': 'Number of patients who required dose adjustment for hematologic toxicities while on the study.'}, {'measure': 'Number of patients who experienced neutropenia.', 'timeFrame': '22 months', 'description': 'Patients who experienced neutropenia as a result of their participation in the study.'}, {'measure': 'Duration of therapy', 'timeFrame': '22 months', 'description': 'Number of patients who completed the study compared to the number of patients who were was discontinued with the most common reason for discontinuation being disease progression'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': '22 months', 'description': 'Progression free survival duration of patients that were in the study who received Palbociclib'}, {'measure': 'Adherence to manufacturer monitoring recommendations', 'timeFrame': '22 months', 'description': 'Patient adherence was also a limitation of this study as providers relied on the patient report to track medication adherence. Insurance coverage and access to palbociclib also contributed some variability as there were occasional delays in initiation of therapy or change in dose.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Breast Cancer', 'Advanced Breast Cancer', 'Estrogen Receptor-positive Breast Cancer', 'Human Epidermal Growth Factor 2 Negative Carcinoma of Breast']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if patients with ER+, human epidermal growth factor 2 negative (HER2-), advanced breast cancer are receiving dosing adjustments and monitoring based on manufacturer recommendations at a tertiary academic medical center.', 'detailedDescription': 'This study was a retrospective, single-center study that included women receiving palbociclib for the treatment of ER+, HER2- advanced breast cancer. Exclusion criteria were the presence of brain metastases or active enrollment in a palbociclib clinical trial.\n\nThe primary endpoint was the proportion of patients who were maintained on a palbociclib dose according to the adjustment schedule in package insert recommendations.\n\nThe secondary endpoints were the number of patients dose adjusted for hematologic toxicities, the number of patients experiencing neutropenia, duration of therapy, progression-free survival (PFS), and adherence to manufacturer monitoring recommendations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients seen at RUMC', 'genderDescription': 'women at least 18 years old with - ER+, HER2- advanced breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women at least 18 years old\n* ER+, HER2- advanced breast cancer\n* receiving palbociclib\n\nExclusion Criteria:\n\n* brain metastases\n* on palbociclib clinical trial'}, 'identificationModule': {'nctId': 'NCT03285568', 'briefTitle': 'Patterns of Prescribing and Monitoring of Palbociclib', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Patterns of Prescribing and Monitoring of Palbociclib', 'orgStudyIdInfo': {'id': '16082509'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Palbociclib', 'description': 'women at least 18 years old, with ER+, HER2- advanced breast cancer, and were receiving palbociclib', 'interventionNames': ['Drug: Palbociclib']}], 'interventions': [{'name': 'Palbociclib', 'type': 'DRUG', 'otherNames': ['IBRANCE'], 'description': 'Observe patients receiving palbociclib for dose adjustment and lab monitoring', 'armGroupLabels': ['Palbociclib']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Kathryn Schultz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}