Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2026-03-14 @ 11:15 AM
Study NCT ID:
NCT02362958
Status:
COMPLETED
Last Update Posted:
2020-07-15
First Post:
2015-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-Center Study of Lapatinib in Patients With Trastuzumab-refractory Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077341', 'term': 'Lapatinib'}, {'id': 'D000069287', 'term': 'Capecitabine'}, {'id': 'D000077235', 'term': 'Vinorelbine'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-13', 'studyFirstSubmitDate': '2015-02-08', 'studyFirstSubmitQcDate': '2015-02-12', 'lastUpdatePostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'progression-free survival', 'timeFrame': '36 months', 'description': 'The time from randomization to disease progression or death from any causes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['HER2 Positive Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '35291977', 'type': 'DERIVED', 'citation': 'Duan F, Zhong M, Ma Y, Song C, Zhang L, Lin Y, Wu Z, Zhang Y, Huang J, Xu F, Shi Y, Wang S, Yuan Z, Xia W, Bi X. The efficacy of human epidermal growth factor receptor 2 (HER2) blockade switching mode in refractory patients with HER2-positive metastatic breast cancer: a phase II, multicenter, single-arm study (SYSUCC-005). BMC Cancer. 2022 Mar 15;22(1):271. doi: 10.1186/s12885-022-09399-2.'}]}, 'descriptionModule': {'briefSummary': 'Evaluating the Efficacy of Lapatinib in Combination With Chemotherapy in Patients With Trastuzumab-refractory Metastatic HER2-positive Breast Cancer.', 'detailedDescription': 'Some studies has demonstrated that even in trastuzumab pretreated patients with HER-2 positive breast cancer, might benefit from the treatment of trastuzumab. However, there is small benefit for some patients having short disease-free survival after adjuvant trastuzumab or short progression-free survival after first-line trastuzumab-based therapy. In clinical practice, the investigators also found it is fact. And the investigators have a scientific rationale for clinical testing of lapatinib plus chemotherapy in patients with trastuzumab-refractory, metastatic HER2-positive breast cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Metastatic breast cancer\n* Eastern Cooperative Oncology Group (ECOG) 0 or 1\n* HER2-expressing primary or metastatic tumor\n* Recurrence within 1 year completing adjuvant trastuzumab OR rapid progress following first-line trastuzumab-based care.\n* Measurable disease with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1\n* Normal organ function, including bone marrow function, renal function, liver function, and cardiac function\n* Signed and dated an informed consent form\n* Life expectancy of at least 12 weeks\n\nExclusion Criteria:\n\n* Pregnant or breast feeding\n* left ventricular ejection fraction (LVEF) \\< 45% by echocardiogram\n* Disease-free interval (DFI) less than 12 months\n* Uncontrolled medical problems\n* Any previous malignancy exceptions for carcinoma of the cervix, squamous carcinoma of the skin, or basal cell carcinoma of the skin\n* Patients were unable or unwilling to comply with program requirements'}, 'identificationModule': {'nctId': 'NCT02362958', 'briefTitle': 'A Multi-Center Study of Lapatinib in Patients With Trastuzumab-refractory Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Sun Yat-sen University Cancer Center', 'orgStudyIdInfo': {'id': 'SYSUCC-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lapatinib and Capecitabine or Vinorelbine', 'description': 'Lapatinib 1250mg qd and Capecitabine 1000mg/m2 bid or Vinorelbine 25mg/m2 iv (d1,d8)', 'interventionNames': ['Drug: lapatinib and capecitabine or vinorelbine']}], 'interventions': [{'name': 'lapatinib and capecitabine or vinorelbine', 'type': 'DRUG', 'otherNames': ['Tykerb; Xeloda;NVB'], 'description': 'lapatinib 1250 mg qd and Capecitabine 1000 mg/m2 bid or Vinorelbine 25mg/m2(d1,d8)', 'armGroupLabels': ['Lapatinib and Capecitabine or Vinorelbine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Zhong-Yu Yuan, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sun Yat-sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Zhong-yu Yuan', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}