Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-01 @ 5:12 PM
Study NCT ID:
NCT01210768
Status:
UNKNOWN
Last Update Posted:
2021-11-23
First Post:
2010-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients
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': 'C098534', 'term': 'EC regimen'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 254}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-22', 'studyFirstSubmitDate': '2010-08-31', 'studyFirstSubmitQcDate': '2010-09-27', 'lastUpdatePostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-free survival', 'timeFrame': '5 years', 'description': 'To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '5 years'}, {'measure': 'Quality of life', 'timeFrame': 'Baseline and every 3 weeks during therapy'}, {'measure': 'Safety profiles', 'timeFrame': '5 years', 'description': 'Incidence and severity of adverse event (neutropenia, palmar-plantar erythrodysesthesia, cardiac function, and secondary leukemia) by assessing the toxicities and tolerability'}, {'measure': 'Survival correlation with biomarkers expression', 'timeFrame': 'At approximately of 5 years maximum FU'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase II', 'Pegylated Liposomal Doxorubicin', 'Adjuvant Chemotherapy', 'Breast Cancer'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Primary objective:\n\n* To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer\n\nSecondary objectives:\n\n* To assess the overall survival (OS)\n* To establish the safety profile by assessing the toxicities and tolerability\n* To assess the quality of life (QoL)\n* To evaluate survival correlation with biomarkers expression.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* histologically confirmed invasive, but non-inflammatory, breast adenocarcinoma with stage I or II (if N0, T must be \\>1cm) disease\n* Her2-negative on fluorescence in situ hybridization (FISH) study\n* performance status of ECOG 0, 1\n* female, age between 20 and 70 years\n* life expectancy of at least one year\n* ability to understand and willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Her2 3+ over-expression on immunohistochemistry (IHC), or Her2 amplification on fluorescence in situ hybridization (FISH) study\n* previous or current systemic malignancy with the exception of curatively treated non-melanoma skin cancer or cervical carcinoma in situ, unless there has been a disease-free interval of at least 5 years\n* Patients who have received prior chemotherapy\n* inadequate hematological function defined as absolute neutrophil count (ANC)less than 1,500/mm3, and platelets less than 100,000/mm3\n* inadequate hepatic function defined as: serum bilirubin greater than 1.5 times the upper limit of normal range (ULN) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN\n* inadequate renal function defined as serum creatinine greater than 1.5 times the ULN\n* left ventricular ejection fraction (LVEF) \\< 50% confirmed by multiple-gated acquisition (MUGA) scan or echocardiogram\n* concomitant illness that might be aggregated by chemotherapy or interfere study assessment. For examples, active, non- controlled infection (such as hepatitis B and hepatitis C, HIV, infectious tuberculosis) or other active, non-controlled disease such as congestive heart failure, ischemic heart disease, uncontrolled hypertension or arrhythmia, unstable diabetes mellitus, and active peptic ulcer\n* patients who are presence of liver cirrhosis or are HBV/HCV carrier\n* participation in another clinical trial with any investigational drug within 30 days prior to entry\n* pregnant or breast feeding women\n* fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period and for three months following cessation of treatment'}, 'identificationModule': {'nctId': 'NCT01210768', 'briefTitle': 'A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'TTY Biopharm'}, 'officialTitle': 'A Phase II Randomized Study of Pegylated Liposomal Doxorubicin, Cyclophosphamide Versus Epirubicin-Cyclophosphamide as Adjuvant Chemotherapy in Her2-negative Stage I and II Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'TTYLD0914'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'EC', 'description': 'Cyclophosphamide,600 mg/m2 q3wk and Epirubicin,90 mg/m2 q3wk', 'interventionNames': ['Drug: Epirubicin+Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'LC', 'description': 'liposomal doxorubicin, 37.5 mg/m2 q3wk, and Cyclophosphamide,600 mg/m2 q3wk', 'interventionNames': ['Drug: liposomal-doxorubicin+Cyclophosphamide']}], 'interventions': [{'name': 'Epirubicin+Cyclophosphamide', 'type': 'DRUG', 'description': 'Cyclophosphamide 600 mg/m2 infusion followed by epirubicin 90 mg/m2 infusion on Day 1 in each 21-day treatment cycle. Treatment will be repeated for 4 cycles in the EC arm.', 'armGroupLabels': ['EC']}, {'name': 'liposomal-doxorubicin+Cyclophosphamide', 'type': 'DRUG', 'description': 'Cyclophosphamide 600 mg/m2 infusion followed by pegylated liposomal-doxorubicin 37.5mg/m2 infusion on Day 1 in each 21-day treatment cycle. Treatment will be repeated for 5 cycles in the LC arm.', 'armGroupLabels': ['LC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Changhua', 'country': 'Taiwan', 'facility': 'Changhua Christian Hospital', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'city': 'Linkou District', 'country': 'Taiwan', 'facility': 'Chang-Gung Memorial Hospital, Linkou', 'geoPoint': {'lat': 25.07777, 'lon': 121.39348}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Taichung Veterans General Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Shin Kong Wu Ho-Su Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ming-Feng Hou, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TTY Biopharm', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}