Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT04566458
Status:
COMPLETED
Last Update Posted:
2021-10-07
First Post:
2020-09-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RWD Study in HER2+ mBC Patients in Third-Line Therapy
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-06', 'studyFirstSubmitDate': '2020-09-22', 'studyFirstSubmitQcDate': '2020-09-22', 'lastUpdatePostDateStruct': {'date': '2021-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Canada', 'timeFrame': 'up to 2 years', 'description': 'The proportion of each type of treatment received for all lines of therapy in the metastatic setting will be determined.'}, {'measure': 'To describe the brain metastatic HER2+ mBC subpopulation during third line', 'timeFrame': 'up to 2 years', 'description': 'The proportion of HER2+ mBC having brain metastasis at start of third lineas well as number of patients developing brain metastasis during third line will be quantified.'}, {'measure': 'To describe radiation therapies received for brain metastasis in HER2+ mBC during third line.', 'timeFrame': 'up to 2 years', 'description': 'The proportion of each type of radiation therapy received during third line, the time between brain metastasis detection and whole brain radiation (WBR), and the proportion of patients receiving a second WBR before death will be quantified.'}, {'measure': 'To calculate the median overall survival (OS) of HER2+ mBC patients who received third-line therapy in Canada.', 'timeFrame': 'up to 2 years', 'description': 'The 2-year survival rate and median OS in third-line HER2+ mBC patients will be quantified.'}, {'measure': 'To calculate the median PFS of HER2+ mBC patients receiving third-line therapy in Canada', 'timeFrame': 'up to 2 years', 'description': 'The median PFS in third-line HER2+ mBC patients will be quantified.'}, {'measure': 'To calculate the median time to next active anticancer treatment of HER2+ mBC patients receiving third-line therapy in Canada', 'timeFrame': 'up to 2 years', 'description': 'The median time to next active anticancer treatment in third-line HER2+ mBC patients will be quantified .'}, {'measure': 'To assess HRU for HER2+ mBC patients in Canada during third-line therapy.', 'timeFrame': 'up to 2 years', 'description': 'Information regarding HRU from HER2+ mBC patients in Canada during third-line therapy will be analyzed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HER2 positive', 'Real World Data', 'Metastatic Breast cancer', 'Real World Evidence'], 'conditions': ['Breast Cancer Stage IV']}, 'descriptionModule': {'briefSummary': 'This retrospective observational study will collect Canadian real-world data (RWD) from HER2+ metastatic breast cancer (mBC) patients to describe treatment sequences of all therapies received in the metastatic setting, to measure overall survival (OS), progression free survival (PFS), time to next active anti-cancer therapy, and to estimate the health resources utilization (HRU) during third-line therapy.', 'detailedDescription': 'The proportion of treatment received during all lines of therapy in the metastatic setting will be described. The 2-year survival rate and median OS with interquartile range (IQR) for third-line therapy will be calculated. HRU data and costs during third-line therapy will be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population in this study will include up to 100 patients with HER2+ mBC having completed at least two previous lines of anti-HER2 based therapy or a combination of anti-HER2 based therapy and chemotherapy and ongoing third or additional lines of treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale or female patients (≥18 years of age)\n\nPatients with stage IV breast cancer\n\nPatients with HER2+ status in metastatic setting\n\nPatients that received at least two lines of active anti-cancer drugs due to disease progression.\n\nPatients that began third-line therapy prior to October 31, 2018.\n\nExclusion Criteria:\n\nPatients treated with an investigational anticancer agent in the ≥ 3rd line setting'}, 'identificationModule': {'nctId': 'NCT04566458', 'briefTitle': 'RWD Study in HER2+ mBC Patients in Third-Line Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Exactis Innovation'}, 'officialTitle': 'Real-World Data Study in HER2+ Metastatic Breast Cancer Patients in Third-Line Therapy', 'orgStudyIdInfo': {'id': 'Exactis-05'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single arm', 'description': 'Her2 positive mBC patients who have received at least 3 lines of treatment in the metastatic setting.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'otherNames': ['No treatment was administered'], 'description': 'retrospective chart review study', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Centre hospitalier universitaire Dr-Georges-L.-Dumont', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'The Moncton Hospital', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "CHUM- Centre hospitalier de l'universite de Montreal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHUQ- Centre hospitalier universitaire de Québec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': "CHUS-CIUSSS de l'Estrie - CHUS - Hôtel-Dieu and CHUS - Hôpital Fleurimont", 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Gerald Batist', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Exactis Innovation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The results of this retrospective observational study will not be formally documented in a Clinical Study Report. Coded patient-level data will be shared with the sponsor.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Exactis Innovation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Knight Therapeutics', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}