Breast Cancer Clinical Trial
Official title:
A Phase III Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel Versus Trastuzumab and Paclitaxel for First-Line Therapy of Metastatic Breast Cancer
| Verified date | March 2009 |
| Source | Sopherion Therapeutics |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of the study is to examine the safety and effectiveness of the drug combination of Myocet, paclitaxel and trastuzumab compared to paclitaxel and trastuzumab without Myocet, as first line treatment for patients with metastatic HER2+ breast cancer.
| Status | Active, not recruiting |
| Enrollment | 363 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Metastatic Her2+ Breast cancer by FISH analysis - No prior chemotherapy for metastatic disease - Measurable disease - normal left ventricular ejection fraction Exclusion Criteria: - prior doxorubicin treatment exceeding 300 mg/m2 or epirubicin exceeding 600 mg/m2 - relapse within 12 months of completion of adjuvant trastuzumab, taxane or anthracycline therapy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Centro Oncologico de Excelencia | Buenos Aires | |
| Argentina | Hospital Enrique Tornú | Buenos Aires | |
| Argentina | Hospital Interzonal Gral de Agudos " EVITA" | Buenos Aires | |
| Argentina | Hospital Profesor A. Posadas | Buenos Aires | |
| Argentina | Santorio Municipal Dr. J. Mendez | Buenos Aires | |
| Argentina | Unidad Oncologica del Neuquen | Neuquen | |
| Argentina | CAICI Instituto | Santa Fe | |
| Argentina | Centro Oncologico Rosario | Santa Fe | |
| Argentina | ISIS Clinica Especializada | Santa Fe | |
| Argentina | Ceten | Villa Dominico | |
| Canada | QEII Health Sciences Centre | Halifax | Nova Scotia |
| Canada | London Regional Cancer Centre/London Health Science Centre | London | Ontario |
| Canada | Dr. Leon Richard Oncology Centre | Moncton | New Brunswick |
| Canada | CHUM Hospital Notre-Dame | Montreal | Quebec |
| Canada | McGill University | Montreal | Quebec |
| Canada | The Ottawa Hospital Regional Cancer Center | Ottawa | Ontario |
| Canada | Hopital du St. Sacrement | Quebec | |
| Canada | Allan Blair Cancer Centre | Regina | Saskatchewan |
| Canada | Saskatoon Cancer Centre | Saskatoon | Saskatchewan |
| Canada | Princess Margaret Hospital | Toronto | Ontario |
| Germany | U.K Charité, Campus Mitte | Berlin | |
| Germany | Universitätsklinikum Magdeburg | Magdeburg | |
| Germany | Gemeinschaftspraxis Gynäkologie & Geburtshilfe | Mannheim | |
| Germany | Frauenklinik von Roten Kreuz | München | |
| Germany | Klinikum Offenbach | Offenbach | |
| Germany | Üniversitäts Klinikum Tübingen | Tübingen | |
| Germany | Dr. Horst Schmidt Kliniken | Wiesbaden | |
| India | Gujarat Cancer Research Institute | Asarwa | Gujarat |
| India | Kidwai Memorial Institute of Oncology | Bangalore | |
| India | Manipal Hospital | Bangalore | |
| India | Apollo Specialty Hospitals, Chennai | Chennai | |
| India | Nizam's Institute of Medical Science | Hyderabaad | |
| India | SMSMedicalCollegeHospital, | Jaipur | |
| India | Lakeshore Hospital and Research Centre Ltd | Kerala | |
| India | Himadri cancer welfare trusr | Kolkata | |
| India | Orchid Nursing Home, | Kolkata | |
| India | Ruby Hall Clinic | Maharashtra | |
| India | Tata Memorial Hospital | Maharashtra | |
| India | Kasturba Medical College, | Mangalore | |
| India | Jaslok Hospital and Research Centre | Mumbai | |
| India | Batra Hospital & Medical Research Center | New Delhi | |
| India | Indraprastha Apollo Hospitals | New Delhi | |
| India | Safdarjung Hospital & Vardhaman Mahaveer Medical College | New Delhi | |
| India | Fortis Hospital | Noida | |
| Italy | Azienda Ospedialera Pugliese-Ciaccio | Catanzaro | |
| Italy | Clinica Oncologica Ospedale | Chieti | |
| Italy | DIMI - Università di Genova | Genova | |
| Italy | ARNAS CIVICO. Presidio Ospedaliero M. Ascoli | Palermo | |
| Italy | Oncologia Medica | Pavia | |
| Italy | Day Hospital Oncologico, | Roma | |
| Italy | Istituto Clinico Humanitas | Rozzano | |
| Poland | SP SK nr1 ACK AMG | Gdansk | |
| Poland | Centrum Onkologii - Instytut Marii Sklodowskiej-Curie Oddzial Gliwice | Gliwice | |
| Poland | Regionalny Osrodek Onkologiczny | Lódz | |
| Poland | Samodzielny Publiczny Szpital | Lublin | |
| Poland | Zaklad Opieki Zdrowotnej MSWiA | Olsztyn | |
| Poland | Regionalny Szpital Specjalistyczny | Swidnica | |
| Poland | Szpital Wojewódzki im. Sw. Lukasza | Tarnow | |
| Poland | Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie | Warszawa | |
| Poland | Wojskowy Instytut Medyczny | Warszawa | |
| Poland | SP ZOZ Szpital Wojewódzki | Zielona Gora | |
| Portugal | nstituto Português de Oncologia Francisco Gentil | Lisbon | |
| Russian Federation | Non-state Health Care Insitution "N.A. Semashko Central Clinical Hospital #2" of the "Russian Railways" Joint Stock Company | Moscow | |
| Russian Federation | State Institution "N.N. Blokhin Russian Oncology Scientific Center" of the Russian Academy of Medical Sciences | Moscow | |
| Russian Federation | State Science Institution "P.A. Hertzen Moscow Oncology Research Institute" of the Federal Agency of Health Care and Social Development | Moscow | |
| Russian Federation | State Health Care Institution "Regional Clinical Oncology Dispensary" | Ryazan | |
| Russian Federation | Municipal Health Care Institution of the City of Sochi "Oncology Dispensary" | Sochi | |
| Russian Federation | St. Petersburg State Health Care Institution "City Clinical Oncology Dispensary" | St Petersberg | |
| Russian Federation | State Science Institution "Prof. N.N. Petrov Research Institute of Oncology" of the Federal Agency of Health Care and Social Development | St Petersberg | |
| Russian Federation | Research Institute of Pulmonology affiliated with State Educational Institution "St. Petersburg State Medical University n.a. academician I.P. Pavlov" of the Federal Agency of Health Care and Social Development | St. Petersberg | |
| Russian Federation | State Health Care Institution "Leningrad Regional Oncology Dispensary" | St. Petersburg | |
| Russian Federation | State Health Care Institution of the Yaroslavl Region "Yaroslavl Regional Oncology Dispensary" | Yaroslavl | |
| Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
| Spain | Hospital Universitario Vall d'Hebron | Barcelona | |
| Spain | Hospital Universitari Arnau de Vilanova de Lleida | Lleida | |
| Spain | Hospital 12 de Octubre | Madrid | |
| Spain | Hospital Son Dureta | Palma de Mallorca | |
| Spain | Hospital Clínico Universitario de Salamanca | Salamanca | |
| Spain | Hospital Virgen Macarena | Sevilla | |
| Spain | Hospital Mutua de Terrassa | Terrassa | |
| Spain | Hospital Clínico Universitario de Valencia | Valencia | |
| Spain | Hospital General Universitario de Valencia | Valencia | |
| Spain | Hospital Clínico Universitario Lozano Blesa | Zaragoza | |
| United Kingdom | Broomfield Hospital | Broomfield | |
| United Kingdom | Christie Hospital NHS Trust | Cardiff | |
| United Kingdom | Guy's Hospital | London | |
| United Kingdom | Royal Free Hospital | London | |
| United States | University of Colorado | Aurora | Colorado |
| United States | Vita Hematology Oncology | Bethlehem | Pennsylvania |
| United States | Aultman Hospital Cancer Center | Canton | Ohio |
| United States | M. Francisco Gonzalez | Columbia | South Carolina |
| United States | Hematology Oncology Consultants, Inc. | Columbus | Ohio |
| United States | John B. Amos Cancer Center | Columbus | Georgia |
| United States | Northwest Hematology/Oncology Associates | Coral Springs | Florida |
| United States | Western Maryland Health System | Cumberland | Maryland |
| United States | Hematology & Oncology Associates of NEPA | Dunmore | Pennsylvania |
| United States | Brody School of Medicine @ ECU | Greenville | North Carolina |
| United States | Hutchinson Clinic P.A. | Hutchinson | Kansas |
| United States | Osceola Cancer Center | Kissimmee | Florida |
| United States | Tennessee Cancer Specialists | Knoxville | Tennessee |
| United States | PA Oncology Hematology Asso | Philadelphia | Pennsylvania |
| United States | UM/Sylvester Cancer Center | Plantation | Florida |
| United States | Scripps Cancer Center Clinical Research | San Diego | California |
| United States | Sioux Valley Clinic | Sioux Falls | South Dakota |
| United States | Clintell, Inc | Skokie | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Sopherion Therapeutics |
United States, Argentina, Canada, Germany, India, Italy, Poland, Portugal, Russian Federation, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-Free Survival | |||
| Secondary | Overall Survival | |||
| Secondary | Safety |
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