Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2026-01-07 @ 5:59 PM
Study NCT ID:
NCT01652560
Status:
UNKNOWN
Last Update Posted:
2012-07-30
First Post:
2012-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Studies of the Application of Bevacizumab in HER2-negative Breast Cancer Neoadjuvant Chemotherapy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2014-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-07-25', 'studyFirstSubmitDate': '2012-07-21', 'studyFirstSubmitQcDate': '2012-07-25', 'lastUpdatePostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': 'From enrollment to disease progression', 'description': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.'}], 'secondaryOutcomes': [{'measure': 'overall response', 'timeFrame': 'From enrollment to disease progression', 'description': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bevacizumab', 'neoadjuvant chemotherapy', 'HER2-negative breast cancer'], 'conditions': ['Breast Cancer', 'Bevacizumab', 'Neoadjuvant Chemotherapy', 'Molecular Targeted Therapy']}, 'descriptionModule': {'briefSummary': '\\- The purpose of this study is to evaluate the efficacy and safety of the application of bevacizumab combined neoadjuvant chemotherapy in HER2-negative breast cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer patients of vascular endocrine surgery department in Xijing Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HER2-negative breast cancer patients\n* Without surgery\n* Plans to neoadjuvant chemotherapy\n\nExclusion Criteria:\n\n* HER2-positive breast cancer patients\n* Post-operative patients'}, 'identificationModule': {'nctId': 'NCT01652560', 'acronym': 'BIBC', 'briefTitle': 'Observational Studies of the Application of Bevacizumab in HER2-negative Breast Cancer Neoadjuvant Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Observational Studies of the Application of Bevacizumab in HER2-negative Breast Cancer Neoadjuvant Chemotherapy', 'orgStudyIdInfo': {'id': 'QTDS-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'bevacizumab combined neoadjuvant chemotherapy', 'interventionNames': ['Drug: bevacizumab']}], 'interventions': [{'name': 'bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'The patients will be treated with Avastin combined neoadjuvant chemotherapy', 'armGroupLabels': ['bevacizumab combined neoadjuvant chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710032', 'city': "Xi'an", 'state': 'Shaanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Nanlin Li, Ph.D', 'role': 'CONTACT', 'email': 'nanlin-74@163.com', 'phone': '+86-186-2963-7041'}, {'name': 'Hongyu Xiao, Master', 'role': 'CONTACT', 'email': 'louch2008@126.com', 'phone': '+86-186-2963-7040'}], 'facility': 'Xijing Hospital ， Fourth Military Medical University', 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'centralContacts': [{'name': 'Nanlin Li, Phd', 'role': 'CONTACT', 'email': 'nanlin-74@163.com', 'phone': '+86-186-2963-7041'}, {'name': 'Hongyu Xiao, Master', 'role': 'CONTACT', 'email': 'louch2008@116.com', 'phone': '+86-186-2963-7040'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LiNanlin,Ph.D, Chief Physician,Clinical Professor', 'class': 'OTHER'}, 'collaborators': [{'name': 'Roche Pharma AG', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'The department of Vascular endocrine surgery', 'investigatorFullName': 'LiNanlin,Ph.D, Chief Physician,Clinical Professor', 'investigatorAffiliation': 'Xijing Hospital'}}}}