Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-02-27 @ 4:07 PM
Study NCT ID:
NCT02443467
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2015-05-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early 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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2015-05-11', 'studyFirstSubmitQcDate': '2015-05-12', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with adverse events', 'timeFrame': 'Up to 3 years'}, {'measure': 'Percentage of participants with serious adverse events', 'timeFrame': 'Up to 3 years'}]}, 'conditionsModule': {'conditions': ['Breast Cancer, Early Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This was an open-labeled, multi-center, prospective, non-comparative study of the safety of Herceptin (trastuzumab) used as an adjuvant therapy in patients with early breast cancer who had previously received antracycline therapy before or after surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with HER2-positive early breast cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients \\> or = 18 years of age\n* Human Epidermal Growth Factor Receptor 2 (HER2)-neu overexpression\n* Previously treated with adjuvant antracycline containing chemotherapy\n* Left Ventricular Ejection Fraction (LVEF) \\> 50%\n* Eastern Cooperative Oncology Group (ECOG) score \\< or = 2\n* Life expectancy \\> or = 12 weeks\n\nExclusion Criteria:\n\n* Left Ventricular Ejection Fraction (LVEF) \\< 50%\n* Advanced pulmonary disease\n* Severe dyspnea\n* Abnormal laboratory results within 14 days prior to registration\n* Peripheral neuropathy\n* Presence of Central Nervous System (CNS) metastasis'}, 'identificationModule': {'nctId': 'NCT02443467', 'briefTitle': 'A Study to Determine the Safety and Tolerability of Herceptin as an Adjuvant Therapy of Early Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'orgStudyIdInfo': {'id': 'ML20397'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HER2-positive early breast cancer', 'description': 'Human Epidermal Growth Factor Receptor 2 (HER2)-positive early breast cancer treated with loading dose of Herceptin (trastuzumab) administered as 6 mg/kg followed by once in 3 weeks administration at 4 mg/kg up to 12 months of treatment', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'armGroupLabels': ['HER2-positive early breast cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21204', 'city': 'Kamenitz', 'country': 'Serbia', 'geoPoint': {'lat': 45.22334, 'lon': 19.84263}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}