Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-28 @ 7:14 PM
Study NCT ID:
NCT00051103
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2003-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-14', 'studyFirstSubmitDate': '2003-01-03', 'studyFirstSubmitQcDate': '2003-01-03', 'lastUpdatePostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Refractory'], 'conditions': ['Metastatic Breast Cancer', 'Neoplasms, Breast']}, 'referencesModule': {'references': [{'pmid': '19179558', 'type': 'BACKGROUND', 'citation': 'Blackwell KL, Pegram MD, Tan-Chiu E, Schwartzberg LS, Arbushites MC, Maltzman JD, Forster JK, Rubin SD, Stein SH, Burstein HJ. Single-agent lapatinib for HER2-overexpressing advanced or metastatic breast cancer that progressed on first- or second-line trastuzumab-containing regimens. Ann Oncol. 2009 Jun;20(6):1026-31. doi: 10.1093/annonc/mdn759. Epub 2009 Jan 29.'}], 'seeAlsoLinks': [{'url': 'http://www.findclinicalstudy.com/rdt.cfm?R=gov&d=642&t=1', 'label': 'A website where viewers can complete a clinical study-matching questionnaire and also sign up for future study notification and healthcare newsletters.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: (The patient must meet the following criteria in order to be eligible for this study.)\n\n* Signed informed consent\n* No more than two prior regimens for metastatic breast cancer. Each regimen must have contained Herceptin.\n* Refractory Stage IIIb or IV breast cancer\n* HER2/neu tumor overexpression\n* Disease progression while receiving a prior chemotherapy regimen with Herceptin alone or in combination with other chemotherapy.\n* Tumor tissue available for testing.\n* 2 weeks since treatment with Herceptin (alone or in combination).\n* Able to swallow and retain oral medication\n* Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan).\n* Adequate kidney and liver function\n* Adequate bone marrow function\n\nExclusion Criteria: (The patient cannot meet any of the following criteria in order to be eligible for this study.)\n\n* Prior regimens did not include Herceptin.\n* Pregnant or lactating.\n* Conditions that would affect absorption of an oral drug\n* Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.\n* Severe cardiovascular disease or cardiac disease requiring a device.\n* Active infection.\n* Brain metastases.\n* Concurrent cancer therapy or investigational therapy.\n* Use of oral or IV steroids.\n* Unresolved or unstable serious toxicity from prior therapy.\n* Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor other than Herceptin."}, 'identificationModule': {'nctId': 'NCT00051103', 'briefTitle': 'Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.', 'nctIdAliases': ['NCT00044330', 'NCT00053066'], 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving Herceptin Containing Regimens', 'orgStudyIdInfo': {'id': 'EGF 20002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Investigational Cancer Drug', 'type': 'DRUG'}]}, 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