Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-31 @ 3:52 PM
Study NCT ID:
NCT00448305
Status:
COMPLETED
Last Update Posted:
2012-01-05
First Post:
2007-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C511389', 'term': 'MBT-0206'}, {'id': 'D017239', 'term': 'Paclitaxel'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-03', 'studyFirstSubmitDate': '2007-03-15', 'studyFirstSubmitQcDate': '2007-03-15', 'lastUpdatePostDateStruct': {'date': '2012-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '4-month progression free survival (PFS) rate', 'timeFrame': '4 month'}], 'secondaryOutcomes': [{'measure': 'median progression free survival (PFS) time', 'timeFrame': 'progression of last patient'}, {'measure': 'tumor response', 'timeFrame': 'Last patient out'}, {'measure': '4-month survival rate', 'timeFrame': '4-month'}, {'measure': 'median overall survival time', 'timeFrame': 'Withdrawal or death of last patient'}, {'measure': 'pain assessment', 'timeFrame': 'Last patient out'}, {'measure': 'clinical benefit assessment via quality of life (QoL)Scale', 'timeFrame': 'Last patient out'}, {'measure': 'adverse events', 'timeFrame': 'Last patient out'}, {'measure': 'laboratory values', 'timeFrame': 'Last patient out'}, {'measure': 'dose variations', 'timeFrame': 'Last patient out'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['breast cancer', 'metastatic', 'relapsed', 'triple-receptor negative', 'EndoTAG-1', 'metastatic or relapsed breast neoplasm'], 'conditions': ['Breast Neoplasms']}, 'referencesModule': {'references': [{'pmid': '24667715', 'type': 'DERIVED', 'citation': 'Awada A, Bondarenko IN, Bonneterre J, Nowara E, Ferrero JM, Bakshi AV, Wilke C, Piccart M; CT4002 study group. A randomized controlled phase II trial of a novel composition of paclitaxel embedded into neutral and cationic lipids targeting tumor endothelial cells in advanced triple-negative breast cancer (TNBC). Ann Oncol. 2014 Apr;25(4):824-831. doi: 10.1093/annonc/mdu025.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the efficacy, safety and tolerability of a therapy with EndoTAG-1 + paclitaxel in combination and EndoTAG-1 alone as a rescue therapy for patients with relapsed or metastatic triple receptor negative breast cancer (a special subgroup of breast cancer).', 'detailedDescription': 'Breast cancer is still a major public health problem worldwide, as it is by far the most frequent neoplasm in women. In recent years so-called "profiling of breast cancer" with expression arrays has become common and it was suggested that the results will allow individualization of care. Breast cancer may now be subclassified into luminal, basal, and HER-2 subtypes with distinct differences in prognosis and response to therapy. About 80% of all basal-like-breast cancers possess a so-called "triple-receptor-negative" phenotype.\n\nPatients with "triple receptor negative breast cancer" have a complete absence of hormone receptors incl. HER-2, an aggressive clinical course and a paucity of treatment options. The only therapeutic option is chemotherapy and in this respect the choice of cytostatic agents is limited. Against this background, the study tries to find another therapeutic option by combining a vascular-disrupting activity with the cytostatic effects of paclitaxel in the study drug EndoTAG-1.\n\nComparison: EndoTAG-1 + paclitaxel (combination therapy) and EndoTAG-1 (monotherapy) in comparison to paclitaxel (control group)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically proven triple-receptor-negative metastatic or relapsed breast cancer\n* Minimum interval of 6 months after the end of any previous taxane- containing chemotherapy regimen\n* At least one tumor lesion measurable according to RECIST criteria\n* Gender: female\n* Age \\>= 18 years old\n* Negative pregnancy test (females of childbearing potential)\n* Willingness to perform double-barrier-contraception during study and for 6 months post chemotherapy treatment\n* ECOG performance status 0, 1 or 2\n* Signed informed consent\n\nExclusion Criteria:\n\n* More than 1 previous chemotherapeutic treatment for metastatic or relapsed disease\n* Major surgery \\< 4 weeks prior to enrollment\n* Immunotherapy \\< 2 weeks prior to enrollment\n* Severe pulmonary obstructive or restrictive disease\n* Uncontrolled inflammatory disease (autoimmune or infectious)\n* Clinically significant cardiac disease (NYHA stadium \\> 2)\n* Laboratory tests (hematology, chemistry) outside specified limits\n* Pregnancy or nursing status\n* Known positive HIV testing\n* Known hypersensitivity to any component of the EndoTAG-1 or taxane formulations\n* History of malignancy other than breast cancer \\< 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally\n* Known progressive cerebral metastasis (patients with cerebral metastases in a stable state or after successful surgical or radiological treatment are allowed to participate in the study)\n* History of active or significant neurological disorder or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial\n* Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry'}, 'identificationModule': {'nctId': 'NCT00448305', 'briefTitle': 'EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'MediGene'}, 'officialTitle': 'An Open-label, Randomized, Controlled Phase-II Trial Evaluating the Efficacy and Safety of EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients', 'orgStudyIdInfo': {'id': 'CT 4002'}, 'secondaryIdInfos': [{'id': 'EudraCT-Nr. 2006-002221-23'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'EndoTAG-1 + Paclitaxel', 'interventionNames': ['Drug: EndoTAG-1 + paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'EndoTAG-1', 'interventionNames': ['Drug: EndoTAG-1']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'Paclitaxel', 'interventionNames': ['Drug: Paclitaxel']}], 'interventions': [{'name': 'EndoTAG-1 + paclitaxel', 'type': 'DRUG', 'description': 'EndoTAG-1 22 mg/m² + Paclitaxel 70 mg/m² weekly', 'armGroupLabels': ['1']}, {'name': 'EndoTAG-1', 'type': 'DRUG', 'description': 'EndoTAG-1 44 mg/m² twice weekly', 'armGroupLabels': ['2']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Paclitaxel 90 mg/m² weekly', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': "Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles", 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Brugmann', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'city': 'Edegem', 'country': 'Belgium', 'facility': 'UZ Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Nice', 'country': 'France', 'facility': 'Cente Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Paris', 'country': 'France', 'facility': 'Institut Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Tours', 'country': 'France', 'facility': 'Hôpital de Jour Centre Henri Kaplan', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}, {'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'city': 'Ahmedabad', 'country': 'India', 'facility': 'Vedanta Institute of Medical Science', 'geoPoint': {'lat': 23.02579, 'lon': 72.58727}}, {'city': 'Bangalore', 'country': 'India', 'facility': 'Bangalore Institute of Oncology', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'city': 'Jaipur', 'country': 'India', 'facility': 'Searoc Cancer Center', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'city': 'Kochi', 'country': 'India', 'facility': 'Lakeshore Hospital', 'geoPoint': {'lat': 9.93988, 'lon': 76.26022}}, {'city': 'Pune', 'country': 'India', 'facility': 'Deenanath Mangeshkar Hospital', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}, {'city': 'Thane', 'country': 'India', 'facility': 'Kaushalya Medical Foundation', 'geoPoint': {'lat': 19.19704, 'lon': 72.96355}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': 'Wojewodzkie Centrum Onkologii', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Gliwice', 'country': 'Poland', 'facility': 'Centrum Onkologii Instytut im. M. Sklodowskiej-Curie', 'geoPoint': {'lat': 50.29761, 'lon': 18.67658}}, {'city': 'Lublin', 'country': 'Poland', 'facility': 'Instytut im. M. Sklodowskiej-Curie', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Olsztyn', 'country': 'Poland', 'facility': 'NZOZ Grupowa Specjalistyczna', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Klinika Onkologii Adadmii Medycznej', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Institute of Oncology "Prof. Dr. Al. Trestioreanu"', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Cluj-Napoca', 'country': 'Romania', 'facility': 'Institute of Oncology "Prof. Dr. I. 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