Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-01-02 @ 5:32 AM
Study NCT ID:
NCT00431795
Status:
TERMINATED
Last Update Posted:
2013-02-13
First Post:
2007-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic 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': 'C506643', 'term': 'liposomal doxorubicin'}, {'id': 'D015251', 'term': 'Epirubicin'}], 'ancestors': [{'id': 'D004317', 'term': 'Doxorubicin'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'whyStopped': 'Due to poor accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-12', 'studyFirstSubmitDate': '2007-02-05', 'studyFirstSubmitQcDate': '2007-02-05', 'lastUpdatePostDateStruct': {'date': '2013-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of antitumor efficacy by objective tumor response rates', 'timeFrame': 'Objective responses confirmed by CT or MRI (on 3rd and 6th cy)'}], 'secondaryOutcomes': [{'measure': 'Toxicity profile and tolerance between the two treatment arms', 'timeFrame': 'Toxicity assessment of each chemotherapy cycle'}, {'measure': 'Time to progression', 'timeFrame': '1 year'}, {'measure': 'Overall survival', 'timeFrame': '1 year'}]}, 'conditionsModule': {'keywords': ['Advanced breast cancer', 'Pegylated liposomal doxorubicin', 'Epirubicin'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'DOXORUBICIN is recognized as one of the most active drugs for breast cancer, but its clinical utility is limited because of a cumulative dose-dependent cardiac myopathy that can lead to potentially fatal congestive heart failure. Caelyx (pegylated liposomal doxorubicin) was designed to reduce the cardiotoxicity of doxorubicin while preserving its antitumor efficacy', 'detailedDescription': 'To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line chemotherapy in patient with advanced breast cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Adequate bone marrow function (Absolute neutrophil count \\>1000/mm\\^3, Platelet count\\>100000/mm\\^3, Hemoglobin\\>9gr/mm\\^3)\n* Histologically- or cytologically- confirmed breast adenocarcinoma\n* No prior anthracycline-based chemotherapy as treatment of advanced breast cancer\n* No prior chemotherapy with ≥ 300mg/m2 doxorubicin or ≥ 540mg/m2 epirubicin as adjuvant setting\n* At least 4 weeks interval since prior anticancer treatment\n* Measurable disease as defined by the presence of at least one measurable lesion(except bone metastases, ascites or pleural effusions)\n* Life expectancy \\> 3 months\n* Written informed consent\n\nExclusion Criteria:\n\n* Pregnancy or nursing\n* Documented history of congestive heart failure (CHF), serious arrhythmia, or myocardial infarction (within 6 months)\n* Other invasive malignancy except nonmelanoma skin cancer or acute infection.\n* Radiation of measurable disease (except brain metastases)\n* Progressive brain metastases according to clinical or radiological criteria.\n* Brain metastases without prior radiation therapy'}, 'identificationModule': {'nctId': 'NCT00431795', 'briefTitle': 'Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hellenic Oncology Research Group'}, 'officialTitle': 'A Multicenter Randomized Phase II Study of Second Line Chemotherapy With Epirubicin( Farmorubicin) Versus the Pegylated Liposomal Doxorubicin in Advanced Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'CT/03.12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Epi', 'interventionNames': ['Drug: Epirubicin']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Cael', 'interventionNames': ['Drug: Pegylated liposomal doxorubicin (Caelyx)']}], 'interventions': [{'name': 'Pegylated liposomal doxorubicin (Caelyx)', 'type': 'DRUG', 'otherNames': ['Caelyx'], 'description': 'Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m\\^2 IV every 4 weeks for 6 consecutive cycles', 'armGroupLabels': ['2']}, {'name': 'Epirubicin', 'type': 'DRUG', 'otherNames': ['Farmorubicine'], 'description': 'Epirubicin (Farmorubicin) at the dose of 90mg/m\\^2 IV every 3 weeks for 6 consecutive cycles', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71110', 'city': 'Heraklion', 'state': 'Crete', 'country': 'Greece', 'facility': 'University Hospital of Crete', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}, {'city': 'Alexandroupoli', 'country': 'Greece', 'facility': 'University General Hospital of Alexandroupolis, Dep of Medical Oncology', 'geoPoint': {'lat': 40.84995, 'lon': 25.87644}}, {'city': 'Athens', 'country': 'Greece', 'facility': '"IASO" General Hospital of Athens, 1st Dep of Medical Oncology', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': '"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': '"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': '401 Military Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Air Forces Military Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Larissa', 'country': 'Greece', 'facility': 'State General Hospital of Larissa, Dep of Medical Oncology', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'city': 'Piraeus', 'country': 'Greece', 'facility': '"Metaxa\'s" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology', 'geoPoint': {'lat': 37.94203, 'lon': 23.64619}}, {'city': 'Thessaloniki', 'country': 'Greece', 'facility': '"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Dimitris Mavrudis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Crete'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hellenic Oncology Research Group', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital of Crete', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}