Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 11:12 PM
Study NCT ID:
NCT00105456
Status:
COMPLETED
Last Update Posted:
2010-05-06
First Post:
2005-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Patients With HER2-Positive Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': {'count': 1000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-04', 'studyFirstSubmitDate': '2005-03-14', 'studyFirstSubmitQcDate': '2005-03-14', 'lastUpdatePostDateStruct': {'date': '2010-05-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-03-15', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['HER2-Positive Metastatic Breast Cancer', 'HER2'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '24743708', 'type': 'DERIVED', 'citation': 'Yardley DA, Tripathy D, Brufsky AM, Rugo HS, Kaufman PA, Mayer M, Magidson J, Yoo B, Quah C, Ulcickas Yood M. Long-term survivor characteristics in HER2-positive metastatic breast cancer from registHER. Br J Cancer. 2014 May 27;110(11):2756-64. doi: 10.1038/bjc.2014.174. Epub 2014 Apr 17.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective observational cohort study designed to describe effectiveness and safety (treatment outcomes and clinically significant cardiac adverse events, respectively) in patients with HER2-positive metastatic breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from managed care organizations, community physicians or practices, and academic centers.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Signed Informed Consent document (unless the IRB has granted a waiver of consent)\n* Signed Authorization for the Use and Disclosure of Health Information document\n* HER2-positive breast cancer\n* Initial diagnosis of metastatic (Stage IV) breast cancer within 6 months prior to enrollment\n* Availability of cancer-specific historical data points in the patient's medical records\n\nExclusion Criteria:\n\n* There are no exclusion criteria for participation in this trial"}, 'identificationModule': {'nctId': 'NCT00105456', 'briefTitle': 'A Study of Patients With HER2-Positive Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'registHER: An Observational Cohort Study of Patients With HER2 Positive Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': 'H2757n'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Isaiah Dimery, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genentech, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Clinical Trials Posting Group', 'oldOrganization': 'Genentech, Inc.'}}}}