Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-01 @ 8:19 PM
Study NCT ID:
NCT00903656
Status:
TERMINATED
Last Update Posted:
2013-12-24
First Post:
2009-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy
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': 'D000077341', 'term': 'Lapatinib'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'whyStopped': 'Caelyx was not available anymore', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-23', 'studyFirstSubmitDate': '2009-05-14', 'studyFirstSubmitQcDate': '2009-05-15', 'lastUpdatePostDateStruct': {'date': '2013-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of a Lapatinib plus Caelyx combination regimen in the treatment of advanced metastatic breast cancer, in terms of overall response rates (complete or partial response)determined by RECIST'}], 'secondaryOutcomes': [{'measure': 'Safety profile'}, {'measure': 'Occurrence of clinically apparent brain metastases'}, {'measure': 'Overall survival, progression free survival, clinical benefit (CR, PR or stable disease for at least 24 weeks)'}, {'measure': 'Quality of Life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['metastatic breast cancer', 'Her2', 'Lapatinib', 'Caelyx', 'cardiotoxic'], 'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the potential of a Lapatinib plus Caelyx combination therapy as an effective and safe therapeutic regimen with a favourable cardiotoxicity profile, in the treatment of metastatic breast cancer following failure of prior trastuzumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female patients, age ≥ 18 years\n* Advanced or metastatic breast cancer, histologically confirmed\n* Documented HER2 overexpression (IHC 3+ and/or FISH positive)\n* At least one measurable lesion according to RECIST criteria. Patients with bone-only lesions are not eligible for study entry\n* Documented disease progression\n* Patients may have no more than 1 line of palliative treatment, however prior therapies must include trastuzumab in adjuvant or metastatic setting\n* Life expectancy of at least 12 weeks\n* Performance status 0-1\n* Cardiac ejection fraction \\>= 50% as measured by echocardiogram or MUGA scan\n* Adequate hematology, liver and renal function\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Serious medical or psychiatric disorders that would interfere with the patient's safety or informed consent\n* Severe cardiac disease (uncontrolled angina, arrhythmia, chronic heart failure (CHF) or cardiac disease requiring a device)\n* Ejection fraction below the institutional normal limit\n* Maximum cumulative dose of 360 mg/m2 for doxorubicin and 720 mg/m2 for epirubicin\n* Active bacterial, viral or fungal infection\n* Patients with clinically apparent brain metastases\n* Positivity for HIV, Hepatitis B or C\n* History of other malignancy; patients who have been disease-free for 5 years\n* Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy) or concurrent treatment with an investigational drug or participation in another clinical trial\n* Known hypersensitivity to the study drugs Lapatinib and Caelyx or their excipients"}, 'identificationModule': {'nctId': 'NCT00903656', 'briefTitle': 'Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Arbeitsgemeinschaft medikamentoese Tumortherapie'}, 'officialTitle': 'Lapatinib Plus Caelyx in Patients With Advanced Metastatic Breast Cancer Following Failure of Trastuzumab Therapy - a Phase II Study', 'orgStudyIdInfo': {'id': 'AGMT_MBC-5'}, 'secondaryIdInfos': [{'id': 'EudraCT 2008-004530-25'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caelyx/Lapatinib', 'interventionNames': ['Drug: doxorubicinhydrochloride, Lapatinib']}], 'interventions': [{'name': 'doxorubicinhydrochloride, Lapatinib', 'type': 'DRUG', 'description': 'Lapatinib 1250mg/d p.o. Caelyx 40 mg/m² i.v. q4w for a maximum of 6 cycles', 'armGroupLabels': ['Caelyx/Lapatinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'state': 'Salzburg', 'country': 'Austria', 'facility': 'Uniklinik Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}], 'overallOfficials': [{'name': 'Alois Lang, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LKH Feldkirch'}, {'name': 'Rainhard Ziebermayr, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KH Elisabethinen Linz'}, {'name': 'Richard Greil, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uniklinik Salzburg'}, {'name': 'Hellmut Samonigg, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univ. Klinikum Graz'}, {'name': 'Michael Fridrik, Doz.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AKH Linz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arbeitsgemeinschaft medikamentoese Tumortherapie', 'class': 'OTHER'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}