Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-28 @ 6:14 PM
Study NCT ID:
NCT01291667
Status:
COMPLETED
Last Update Posted:
2011-02-08
First Post:
2011-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study for HER2-Overexpressed MBC Patients Treated by Cipterbin® Plus vinorelbinE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 330}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'lastUpdateSubmitDate': '2011-02-07', 'studyFirstSubmitDate': '2011-02-06', 'studyFirstSubmitQcDate': '2011-02-07', 'lastUpdatePostDateStruct': {'date': '2011-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progress-free survival'}], 'secondaryOutcomes': [{'measure': 'overall response rate,safety'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Progress-free Survival', 'Overall Response Rate', 'Adverse Events']}, 'descriptionModule': {'briefSummary': "Breast cancer is the most common malignant disease and the most frequent causes of cancer mortality in females worldwide. The situation is same as the world in China. Trastuzumab has been proved valuable treatment for HER2-positive breast cancer patients. Cipterbin® is developing by Shanghai CP Guojian Pharmaceutical Co.Ltd.Now we carried on the phase III trial in order to prove Cipterbin® 's efficacy and safety."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'HER2-positive metastatic breast cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed ICF\n* pathologic diagnosis breast cancer\n* HER2+ status defined as IHC3+ Staining or in situ hybridization positive at least 1 measurable lesion as per RECIST criteria age from 18y to 70y KPS\\>=70\n\nExclusion Criteria:\n\n* More than three prior chemotherapy lines for advanced disease LVEF\\<50%\n* prior exposure vinorebine for breast cancer\n* prior exposure Trastuzumab for breast cancer\n* uncontrolled brain metastasis\n* breastfeeding or pregnant'}, 'identificationModule': {'nctId': 'NCT01291667', 'acronym': 'HOPES', 'briefTitle': 'Study for HER2-Overexpressed MBC Patients Treated by Cipterbin® Plus vinorelbinE', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai CP Guojian Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase III Randomized Study for HER2-Overexpressed Metastatic Breast Cancer Patients Treated by Trastuzumab( Cipterbin®) Plus vinorelbinE Simultaneously or Sequencely', 'orgStudyIdInfo': {'id': 'HOPES'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai CP Guojian Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Zefei Jiang', 'oldOrganization': 'Hospital Affiliated to Academy Military Medical Science'}}}}