Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2025-12-28 @ 4:21 AM
Study NCT ID:
NCT00433095
Status:
COMPLETED
Last Update Posted:
2011-03-14
First Post:
2007-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vinorelbine (Oral) Plus Trastuzumab for 1st-line Treatment of HER2/Neu Overexpressing 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D000068878', 'term': 'Trastuzumab'}], 'ancestors': [{'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'lastUpdateSubmitDate': '2011-03-11', 'studyFirstSubmitDate': '2007-02-07', 'studyFirstSubmitQcDate': '2007-02-07', 'lastUpdatePostDateStruct': {'date': '2011-03-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate'}], 'secondaryOutcomes': [{'measure': 'Time to tumor progression'}, {'measure': 'Overall survival'}, {'measure': 'Safety'}]}, 'conditionsModule': {'keywords': ['Navelbine', 'Herceptin', 'oral', 'breast cancer'], 'conditions': ['Carcinoma Breast Stage IV']}, 'descriptionModule': {'briefSummary': '1st-line treatment of HER2/neu overexpressing breast cancer', 'detailedDescription': 'The combination of vinorelbine and trastuzumab was demonstrated to be highly effective in several trials showing response rates in the range of 59-78%. This combination is characterized by good tolerability and can be applied for a prolonged period without the risk of major cumulative toxicity The availability of oral vinorelbine promises a further simplification of therapy. The present trial therefore investigates the safety and efficacy of a combined treatment with trastuzumab and oral vinorelbine.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven, metastatic breats cancer.\n* HER2-neu overexpression (IHC3+ or IHC2+/FISH+)\n* Written informed consent\n* no previous therapy with vinorelbine or trastuzumab\n* Age \\* 18 and \\* 75 years\n* Karnofsky-Performance status \\> 70%\n* Life expectance 16 weeks and more\n* Availability of at least one target lesion according to RECIST-criteria. Target lesions need to be outside of radiation fields. Bone metastases are excluded as indicator leasions\n* Exclusion of pregnancy and adequte contraception during childbearing age.\n\n * Adequate hematological, renal, and hepatic function\n* Normal cardiac function. LVEF should not be \\>10% below normal.\n* Adequate compliance to perform treatment and subsequent follow-up visits\n\nExclusion Criteria:\n\n* Locoregional recurrence of breast cancer only or development of contralateral breast cancer\n* Pregnancy or lactation\n* Symptomatic brain- or meningeal metastasis\n* Concurrent endocrine antitumor therapy\n* Other malignancies except basal cell cancer of the skin or in-situ carcinoma of the cervix\n* Peripheral neuropathy \\>= NCI CTC Grade 2.\n* other severel disease which preclude adequate treatment\n* Participation in a clinical trial within the last 30 days.\n* Psychological, familial, sociological or geographical conditions which preclude treatment according to the protocol or the planned follow-up'}, 'identificationModule': {'nctId': 'NCT00433095', 'briefTitle': 'Vinorelbine (Oral) Plus Trastuzumab for 1st-line Treatment of HER2/Neu Overexpressing Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'orgStudyIdInfo': {'id': 'Mamma-2-2004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Navelbine', 'type': 'DRUG'}, {'name': 'Herceptin', 'type': 'DRUG'}, {'name': 'Navelbine (oraly)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'country': 'Germany', 'facility': 'University of Munich - Klinikum Grosshdern', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Volker Heinemann, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Munich - Klinikum Grosshadern'}, {'name': 'Hans-Joachim Stemmler, PhD, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Munich - Klinikum Grosshadern'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pierre Fabre Laboratories', 'class': 'INDUSTRY'}]}}}