Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2026-02-20 @ 8:26 PM
Study NCT ID:
NCT02761616
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2016-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine Biopsy Rate in Participants With a First Relapse of Breast Cancer
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': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2016-05-03', 'studyFirstSubmitQcDate': '2016-05-03', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of biopsied participants with metastatic relapse', 'timeFrame': 'Approximately up to 24 months'}], 'secondaryOutcomes': [{'measure': 'Percentage of non-biopsied participants at first relapse according to different reasons for not performing a biopsy of the metastasis', 'timeFrame': 'Approximately up to 24 months'}, {'measure': 'Percentage of biopsied and non-biopsied participants at first relapse metastatic breast cancer (mBC) for each metastatic site', 'timeFrame': 'Approximately up to 24 months'}, {'measure': 'Percentage of biopsied participants at first relapse mBC according to each biopsy method', 'timeFrame': 'Approximately up to 24 months'}, {'measure': 'Percentage of biopsied and non- biopsied participants at first relapse mBC for each molecular profile of primary tumor', 'timeFrame': 'Approximately up to 24 months'}, {'measure': 'Percentage of biopsied participants at first relapse mBC for each molecular profile of biopsied metastases', 'timeFrame': 'Approximately up to 24 months'}, {'measure': 'Percentage of biopsied participants at first relapse mBC with same and different molecular profiles between primary tumor and metastasis for each molecular profile', 'timeFrame': 'Approximately up to 24 months'}, {'measure': 'Time to relapse', 'timeFrame': 'Approximately up to 24 months'}, {'measure': 'Percentage of participants with type of first line therapy selected for metastatic disease', 'timeFrame': 'Approximately up to 24 months'}, {'measure': 'Percentage of participants influenced with biopsy in mBC', 'timeFrame': 'Approximately up to 24 months'}, {'measure': 'Percentage of biopsied and non- biopsied participants at first relapse mBC for each systemic treatment scheme in the adjuvant and in the metastatic setting', 'timeFrame': 'Approximately up to 24 months'}]}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a retrospective, and observational cohort study to determine the proportion of breast cancer first relapses, that are biopsied. The duration of the study will be approximately 24 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with a first relapse of breast cancer after being treated for eBC.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with histologically confirmed breast cancer treated for early breast cancer (eBC) with first metastatic relapse disease in the period from January 1, 2014 and December 31, 2015\n\nExclusion Criteria:\n\nNot Applicable'}, 'identificationModule': {'nctId': 'NCT02761616', 'briefTitle': 'A Study to Determine Biopsy Rate in Participants With a First Relapse of Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'orgStudyIdInfo': {'id': 'ML30038'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'eBC treated participants', 'description': 'Participants with metastatic disease after previously being treated for eBC were observed for 24 months.', 'interventionNames': ['Other: eBC treated participants']}], 'interventions': [{'name': 'eBC treated participants', 'type': 'OTHER', 'description': 'No intervention administered in this retrospective observational study.', 'armGroupLabels': ['eBC treated participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1431FWO', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Cemic; Oncologia Clinica', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'city': 'Morón', 'country': 'Argentina', 'facility': 'Hospital de Morón', 'geoPoint': {'lat': -34.65118, 'lon': -58.62205}}, {'city': 'Rosario', 'country': 'Argentina', 'facility': 'CENICLAR', 'geoPoint': {'lat': -32.94682, 'lon': -60.63932}}, {'zip': 'T4000IAK', 'city': 'San Miguel de Tucumán', 'country': 'Argentina', 'facility': 'Centro Medico San Roque', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}