Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-02-25 @ 5:21 AM
Study NCT ID:
NCT01784120
Status:
UNKNOWN
Last Update Posted:
2016-02-10
First Post:
2013-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced 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': 'D004317', 'term': 'Doxorubicin'}, {'id': 'C000708971', 'term': 'genexol-PM'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-02-09', 'studyFirstSubmitDate': '2013-01-30', 'studyFirstSubmitQcDate': '2013-02-03', 'lastUpdatePostDateStruct': {'date': '2016-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'overall survival', 'timeFrame': 'one year'}, {'measure': 'progression-free-survival', 'timeFrame': 'one year'}], 'primaryOutcomes': [{'measure': 'response rate', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'number of participants with adverse events', 'timeFrame': 'one year'}]}, 'conditionsModule': {'keywords': ['breast cancer', 'doxorubicin', 'genexol-PM', 'paclitaxel'], 'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'To evaluate efficacy and toxicity of doxorubicin/Genexol-PM in metastatic breast cancer\n\n1. Primary Purpose: response rate\n2. Secondary purpose: toxicity, progression-free survival, overall survival'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older adult women\n* Instrumentation measurable lesions with histologically confirmed advanced (recurrent or metastatic) breast cancer\n* ECOG 0-2\n* Advanced breast cancer in the past, patients who did not receive chemotherapy\n* Recurrence if adjuvant chemotherapy and adjuvant chemotherapy in the past for more than 6 months until the patient\n* life expectancy more than 3 months\n* Agree in writing before the party to participate in a clinical trial to patients\n\nExclusion Criteria:\n\n* immunohistochemical staining 3 + or FISH positive anti-HER 2 therapy patients\n* Severe infections requiring antibiotic therapy\n* Clinically significant heart disease\n* Pregnant or lactating woman\n* Uncontrolled symptoms in the central nervous system (CNS) metastases\n* Patients diagnosed with malignant tumors of other organs'}, 'identificationModule': {'nctId': 'NCT01784120', 'briefTitle': 'A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'A Phase II Trial of Doxorubicin and Genexol-PM in Patients With Advanced Breast Cancer', 'orgStudyIdInfo': {'id': '2011-GIRBA-2566'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'doxotubicin/Genexol-PM', 'interventionNames': ['Drug: Doxorubicin/Genexol-PM']}], 'interventions': [{'name': 'Doxorubicin/Genexol-PM', 'type': 'DRUG', 'armGroupLabels': ['doxotubicin/Genexol-PM']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hee Kyung Ahn', 'role': 'CONTACT', 'phone': '+82-32-460-3229'}], 'facility': 'Gachon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'centralContacts': [{'name': 'Hee Kyung Ahn', 'role': 'CONTACT', 'email': 'hkahn@gilhospital.com', 'phone': '+82-32-460-3229'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eun Kyung Cho', 'investigatorAffiliation': 'Gachon University Gil Medical Center'}}}}