Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-30 @ 12:18 AM
Study NCT ID:
NCT01288092
Status:
WITHDRAWN
Last Update Posted:
2012-06-07
First Post:
2011-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Australia', 'Belgium', 'Brazil', 'Canada', 'Czechia', 'France', 'Germany', 'Hong Kong', 'Hungary', 'Italy', 'Russia', 'Singapore', 'South Africa', 'Spain', 'Taiwan', 'Thailand', 'Turkey (Türkiye)', 'United Kingdom', 'United States']}, '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': 'C531198', 'term': 'dactolisib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2012-06-05', 'studyFirstSubmitDate': '2011-01-19', 'studyFirstSubmitQcDate': '2011-01-31', 'lastUpdatePostDateStruct': {'date': '2012-06-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival rate after 16 weeks of treatment', 'timeFrame': '16 weeks after the first BEZ235 administration'}], 'secondaryOutcomes': [{'measure': 'determine the efficacy of BEZ235 (objective response rate)', 'timeFrame': 'about 6 months'}, {'measure': 'evaluate the clinical benefit rate of BEZ235', 'timeFrame': 'about 6 months'}, {'measure': 'evaluate the time to response', 'timeFrame': 'about 6 months'}, {'measure': 'evaluate the Progression Free Survival Rate at 16-week & 24-week using the Kaplan-Meier method', 'timeFrame': '16-week & 24-week after the first BEZ235 administration'}, {'measure': 'evaluate safety of BEZ235 (frequency and severity of Adverse Events, abnormal laboratory values, other safety data as appropriate)', 'timeFrame': '30-35 days after treatment discontinuation'}]}, 'conditionsModule': {'keywords': ['Metastatic breast cancer', 'HER2 negative', 'HR positive', 'PI3K pathway', 'no more than 2 prior lines of chemotherapy', 'Metastatic Breast Cancer(MBC)'], 'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-center, open-label, single arm, phase II study with a 2-stage design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in patients with progressive metastatic HR+ HER2- breast cancer who have received at least one prior line of endocrine therapy and two to three prior lines of chemotherapy for metastatic disease. Patients will be stratified into 3 groups according to their PI3K (phosphatidylinositol 3-Kinase) pathway activation status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female ≥ 18 years\n* ECOG performance status ≤ 2\n* Histologically and/or cytologically confirmed diagnosis of breast cancer presenting with metastatic disease (hormone receptor positive and HER2 negative)\n* Known PI3K activation status (defined by PIK3CA (Phosphoinositide-3-kinase, catalytic, alpha polypeptide) mutation and PTEN PTEN (Phosphatase and Tensin Homolog) mutation/expression)\n* Prior treatment with at least one prior line of endocrine therapy and at least two and no more than three prior lines of chemotherapy for metastatic breast cancer\n* Objective and radiologically confirmed progression of disease after prior treatment and at least one measurable lesion as per RECIST\n* Adequate bone marrow and organ function\n\nExclusion Criteria:\n\n* Previous treatment with PI3K and/or mTOR inhibitors\n* Symptomatic Central Nervous System (CNS) metastases\n* Concurrent malignancy or malignancy in the last 5 years prior to start of study treatment\n* Wide field radiotherapy ≤ 28 days or limited field radiation for palliation ≤ 14 days prior to starting study drug\n* Active cardiac disease (e.g. Left Ventricular Ejection Fraction (LVEF) \\< 50%, QTcF \\> 480 msec on screening ECGelectrocardiogram (ECG), unstable angina pectoris, ventricular, supraventricular or nodal arrhythmias)\n* Inadequately controlled hypertension\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of BEZ235\n* Treatment at start of study treatment with drugs with a known risk to induce Torsades de Pointes, moderate and strong inhibitors or inducers of isoenzyme CYP3A4, warfarin and coumadin analogues, LHRH agonists\n* History of photosensitivity reactions to other drugs\n* Pregnant or nursing (lactating) woman\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01288092', 'briefTitle': 'BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase II Study of Orally Administered BEZ235 Monotherapy in Patients With Hormone Receptor Positive, HER2 Negative, Metastatic Breast Cancer, With or Without PI3K Activated Pathway', 'orgStudyIdInfo': {'id': 'CBEZ235B2201'}, 'secondaryIdInfos': [{'id': '2010-024394-39', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BEZ235', 'interventionNames': ['Drug: BEZ235']}], 'interventions': [{'name': 'BEZ235', 'type': 'DRUG', 'armGroupLabels': ['BEZ235']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}, {'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Investigative Site'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}