Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-26 @ 5:01 AM
Study NCT ID:
NCT00377559
Status:
COMPLETED
Last Update Posted:
2015-10-06
First Post:
2006-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Liposomal Doxorubicin and Docetaxel in HER2 Negative Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D066126', 'term': 'Cardiotoxicity'}], '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': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011832', 'term': 'Radiation Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D004317', 'term': 'Doxorubicin'}], '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'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-05', 'studyFirstSubmitDate': '2006-09-15', 'studyFirstSubmitQcDate': '2006-09-15', 'lastUpdatePostDateStruct': {'date': '2015-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiotoxicity (definite or probable cardiac death)', 'timeFrame': 'treatment period'}, {'measure': 'Signs or symptoms of congestive heart failure (CHF), New York Heart Association (NYHA) class III-IV', 'timeFrame': 'treatment period'}, {'measure': 'Decline in left ventricular ejection fraction (LVEF) of ≥ 5% to < 50% with mild signs or symptoms of CHF (NYHA class < III)', 'timeFrame': 'treatment period'}, {'measure': 'Decline in LVEF of ≥ 10% to < 50% without signs or symptoms of CHF', 'timeFrame': 'treatment period'}], 'secondaryOutcomes': [{'measure': 'Frequency and severity of intercurrent events according to the National Cancer Institute - Common Terminology Criteria (NCI-CTC) classification', 'timeFrame': 'treatment period'}, {'measure': 'Response rate', 'timeFrame': 'treatment period'}, {'measure': 'Median time to progression', 'timeFrame': 'treatment period'}, {'measure': 'Progression free survival', 'timeFrame': 'treatment period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'metastatic', 'cardiotoxicity', 'liposomal', 'doxorubicin', 'docetaxel', 'HER2/neu negative metastatic breast cancer'], 'conditions': ['Breast Cancer', 'Neoplasm Metastasis']}, 'descriptionModule': {'briefSummary': 'This is an open phase II multicentre study evaluating the efficacy and safety of the non pegylated liposomal doxorubicin (Myocet®) and docetaxel (Taxotere®) combination as first-line treatment of patients with metastatic HER2/neu negative breast cancer.', 'detailedDescription': 'Phase II non comparative study, assessing the safety (primarily cardiac safety) and efficacy in patients with locally advanced or metastatic HER2/neu negative breast cancer not yet treated with chemotherapy for metastatic disease.\n\nMyocet and Taxotere will be given for a maximum of 6 cycles. Endpoints: cardiotoxicity (left ventricular ejection fraction decrease and/or symptoms of heart failure), serious other toxicity, disease progression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with histologically documented metastatic or locally advanced metastatic HER2/neu negative breast cancer.\n* In the case of previous adjuvant or neoadjuvant chemotherapy with anthracyclines or taxanes, this must have been completed more than 12 months before inclusion.\n* In the case of previous adjuvant or neoadjuvant chemotherapy, cumulative anthracycline dose ≤ 360 mg/m2 of doxorubicin or 600 mg/m2 of epirubicin or 75 mg/m2 of mitoxantrone on inclusion.\n* Previous endocrine therapy is authorized (endocrine therapy other than goserelin must be stopped before starting treatment).\n* Previous radiotherapy is authorized, if discontinued ≥ 4 weeks prior to inclusion in the study and if \\< 10% of the bone marrow was within the irradiated area.\n* Age ≥ 18 years.\n* Performance status 0,1, or 2.\n* Life expectancy ≥ 3 months.\n* Evaluable disease.\n* Normal LVEF (multigated acquisition \\[MUGA\\] scan or echocardiography).\n* Normal haematological, hepatic and renal parameters: neutrophils ≥ 1.5 x 10\\^9/l; platelets ≥ 100 x 10\\^9/l; hemoglobin (Hb) ≥ 6 mmol/L; total bilirubin ≤ 1.5 times the upper limit of normal (ULN); transaminases ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5 x ULN; creatinine ≤ 1.5 x ULN.\n* Dated and signed written informed consent.\n\nExclusion Criteria:\n\n* Previous chemotherapy for metastatic disease.\n* History of other cancer, except for cervical carcinoma in situ treated by cone resection or basal cell or squamous cell skin cancer.\n* History of congestive heart failure or myocardial infarction ≤ 1 year; cardiac function: NYHA ≥ 2 or LVEF \\< 50%. Uncontrolled significant heart disease, such as unstable angina.\n* Poorly controlled hypertension.\n* Performance status 3, 4.\n* Symptomatic or progressive brain metastases.\n* Active infection or other serious underlying disease.\n* Concomitant participation in other clinical trials.\n* Pregnant women or nursing mothers; patients of childbearing potential without effective contraception.\n* Absolute medical contraindication to the use of corticosteroid premedication.\n* Allergy to polysorbate 80, doxorubicin, or egg lecithin.\n* NCI-CTC grade \\> 1 peripheral neuropathy.\n* Patients not able to comply with regular medical follow-up'}, 'identificationModule': {'nctId': 'NCT00377559', 'acronym': 'MYOTAX', 'briefTitle': 'Liposomal Doxorubicin and Docetaxel in HER2 Negative Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Catharina Ziekenhuis Eindhoven'}, 'officialTitle': 'Phase II Multicentre Open Label Trial Evaluating the Efficacy and Safety of the Liposomal Doxorubicin (Myocet®) and Docetaxel (Taxotere®) Combination as First-line Treatment of Patients With Metastatic HER2/Neu Negative Breast Cancer', 'orgStudyIdInfo': {'id': 'MYOTAX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1.', 'description': 'Myocet+docetaxel', 'interventionNames': ['Drug: Non pegylated liposomal doxorubicin and docetaxel']}], 'interventions': [{'name': 'Non pegylated liposomal doxorubicin and docetaxel', 'type': 'DRUG', 'otherNames': ['Myocet, Taxotere'], 'description': 'max. 6 courses', 'armGroupLabels': ['1.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5211 NL', 'city': "'s-Hertogenbosch", 'country': 'Netherlands', 'facility': 'Jeroen Bosch Ziekenhuis', 'geoPoint': {'lat': 51.69917, 'lon': 5.30417}}, {'zip': '9400 RA', 'city': 'Assen', 'country': 'Netherlands', 'facility': 'Wilhelmina Ziekenhuis', 'geoPoint': {'lat': 52.99667, 'lon': 6.5625}}, {'zip': '5602 ZA', 'city': 'Eindhoven', 'country': 'Netherlands', 'facility': 'Catharina-Ziekenhuis', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'zip': '4380 DD', 'city': 'Flushing', 'country': 'Netherlands', 'facility': 'Ziekenhuis Walcheren', 'geoPoint': {'lat': 51.4425, 'lon': 3.57361}}, {'zip': '3083 AN', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Ikazia Ziekenhuis', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '5000 LC', 'city': 'Tilburg', 'country': 'Netherlands', 'facility': 'Sint Elisabeth Ziekenhuis', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}, {'zip': '3527 CE', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Mesos Medisch Centrum', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '5500 MB', 'city': 'Veldhoven', 'country': 'Netherlands', 'facility': 'Maxima Medisch Centrum', 'geoPoint': {'lat': 51.41833, 'lon': 5.40278}}, {'zip': '5900 BX', 'city': 'Venlo', 'country': 'Netherlands', 'facility': 'VieCuri MC', 'geoPoint': {'lat': 51.37, 'lon': 6.16806}}, {'zip': '7100 GG', 'city': 'Winterswijk', 'country': 'Netherlands', 'facility': 'Streekziekenhuis Koningin Beatrix', 'geoPoint': {'lat': 51.9725, 'lon': 6.71944}}], 'overallOfficials': [{'name': 'Laurence J. van Warmerdam, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catharina Ziekenhuis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catharina Ziekenhuis Eindhoven', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cephalon', 'class': 'INDUSTRY'}, {'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Raymond J.P. Schmidt, MD', 'oldOrganization': 'Stichting (Foundation) BO3'}}}}