Trial of Myocet in Metastatic Breast Cancer
Sponsor
Sopherion Therapeutics (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00294996
Collaborator
(none)
363
105
3.5
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
363 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date
:
Jan 1, 2006
Outcome Measures
Primary Outcome Measures
- Progression-Free Survival []
Secondary Outcome Measures
- Overall Survival []
- Safety []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Scripps Cancer Center Clinical Research | San Diego | California | United States | 92121 |
| 2 | University of Colorado | Aurora | Colorado | United States | 80045 |
| 3 | Northwest Hematology/Oncology Associates | Coral Springs | Florida | United States | 33065 |
| 4 | Osceola Cancer Center | Kissimmee | Florida | United States | 34741 |
| 5 | UM/Sylvester Cancer Center | Plantation | Florida | United States | 33324 |
| 6 | John B. Amos Cancer Center | Columbus | Georgia | United States | 31904 |
| 7 | Clintell, Inc | Skokie | Illinois | United States | 60076 |
| 8 | Hutchinson Clinic P.A. | Hutchinson | Kansas | United States | 67502 |
| 9 | Western Maryland Health System | Cumberland | Maryland | United States | 21502 |
| 10 | Brody School of Medicine @ ECU | Greenville | North Carolina | United States | 27834 |
| 11 | Aultman Hospital Cancer Center | Canton | Ohio | United States | 44710 |
| 12 | Hematology Oncology Consultants, Inc. | Columbus | Ohio | United States | 43235 |
| 13 | Vita Hematology Oncology | Bethlehem | Pennsylvania | United States | 18015 |
| 14 | Hematology & Oncology Associates of NEPA | Dunmore | Pennsylvania | United States | 18512 |
| 15 | PA Oncology Hematology Asso | Philadelphia | Pennsylvania | United States | 19106 |
| 16 | M. Francisco Gonzalez | Columbia | South Carolina | United States | 29203 |
| 17 | Sioux Valley Clinic | Sioux Falls | South Dakota | United States | 57104 |
| 18 | Tennessee Cancer Specialists | Knoxville | Tennessee | United States | 37920 |
| 19 | Centro Oncologico de Excelencia | Buenos Aires | Argentina | ||
| 20 | Hospital Enrique Tornú | Buenos Aires | Argentina | ||
| 21 | Hospital Interzonal Gral de Agudos " EVITA" | Buenos Aires | Argentina | ||
| 22 | Hospital Profesor A. Posadas | Buenos Aires | Argentina | ||
| 23 | Santorio Municipal Dr. J. Mendez | Buenos Aires | Argentina | ||
| 24 | Unidad Oncologica del Neuquen | Neuquen | Argentina | ||
| 25 | CAICI Instituto | Santa Fe | Argentina | ||
| 26 | Centro Oncologico Rosario | Santa Fe | Argentina | ||
| 27 | ISIS Clinica Especializada | Santa Fe | Argentina | ||
| 28 | Ceten | Villa Dominico | Argentina | ||
| 29 | Dr. Leon Richard Oncology Centre | Moncton | New Brunswick | Canada | E1C 8X3 |
| 30 | QEII Health Sciences Centre | Halifax | Nova Scotia | Canada | B3H 1V7 |
| 31 | London Regional Cancer Centre/London Health Science Centre | London | Ontario | Canada | N6A 4L6 |
| 32 | The Ottawa Hospital Regional Cancer Center | Ottawa | Ontario | Canada | K1H 8L6 |
| 33 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
| 34 | CHUM Hospital Notre-Dame | Montreal | Quebec | Canada | H2L 4M1 |
| 35 | McGill University | Montreal | Quebec | Canada | H2W 1S6 |
| 36 | Allan Blair Cancer Centre | Regina | Saskatchewan | Canada | S47 7T1 |
| 37 | Saskatoon Cancer Centre | Saskatoon | Saskatchewan | Canada | S7N 4H4 |
| 38 | Hopital du St. Sacrement | Quebec | Canada | G1S 4L8 | |
| 39 | U.K Charité, Campus Mitte | Berlin | Germany | ||
| 40 | Universitätsklinikum Magdeburg | Magdeburg | Germany | ||
| 41 | Gemeinschaftspraxis Gynäkologie & Geburtshilfe | Mannheim | Germany | ||
| 42 | Frauenklinik von Roten Kreuz | München | Germany | ||
| 43 | Klinikum Offenbach | Offenbach | Germany | ||
| 44 | Üniversitäts Klinikum Tübingen | Tübingen | Germany | ||
| 45 | Dr. Horst Schmidt Kliniken | Wiesbaden | Germany | ||
| 46 | Gujarat Cancer Research Institute | Asarwa | Gujarat | India | |
| 47 | Kidwai Memorial Institute of Oncology | Bangalore | India | ||
| 48 | Manipal Hospital | Bangalore | India | ||
| 49 | Apollo Specialty Hospitals, Chennai | Chennai | India | ||
| 50 | Nizam's Institute of Medical Science | Hyderabaad | India | ||
| 51 | SMSMedicalCollegeHospital, | Jaipur | India | ||
| 52 | Lakeshore Hospital and Research Centre Ltd | Kerala | India | ||
| 53 | Himadri cancer welfare trusr | Kolkata | India | ||
| 54 | Orchid Nursing Home, | Kolkata | India | ||
| 55 | Ruby Hall Clinic | Maharashtra | India | ||
| 56 | Tata Memorial Hospital | Maharashtra | India | ||
| 57 | Kasturba Medical College, | Mangalore | India | ||
| 58 | Jaslok Hospital and Research Centre | Mumbai | India | ||
| 59 | Batra Hospital & Medical Research Center | New Delhi | India | ||
| 60 | Indraprastha Apollo Hospitals | New Delhi | India | ||
| 61 | Safdarjung Hospital & Vardhaman Mahaveer Medical College | New Delhi | India | ||
| 62 | Fortis Hospital | Noida | India | ||
| 63 | Azienda Ospedialera Pugliese-Ciaccio | Catanzaro | Italy | ||
| 64 | Clinica Oncologica Ospedale | Chieti | Italy | ||
| 65 | DIMI - Università di Genova | Genova | Italy | ||
| 66 | ARNAS CIVICO. Presidio Ospedaliero M. Ascoli | Palermo | Italy | ||
| 67 | Oncologia Medica | Pavia | Italy | ||
| 68 | Day Hospital Oncologico, | Roma | Italy | ||
| 69 | Istituto Clinico Humanitas | Rozzano | Italy | ||
| 70 | SP SK nr1 ACK AMG | Gdańsk | Poland | ||
| 71 | Centrum Onkologii - Instytut Marii Skłodowskiej-Curie Oddział Gliwice | Gliwice | Poland | ||
| 72 | Samodzielny Publiczny Szpital | Lublin | Poland | ||
| 73 | Zakład Opieki Zdrowotnej MSWiA | Olsztyn | Poland | ||
| 74 | Szpital Wojewódzki im. Św. Łukasza | Tarnow | Poland | ||
| 75 | Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie | Warszawa | Poland | ||
| 76 | Wojskowy Instytut Medyczny | Warszawa | Poland | ||
| 77 | SP ZOZ Szpital Wojewódzki | Zielona Gora | Poland | ||
| 78 | Regionalny Ośrodek Onkologiczny | Łódź | Poland | ||
| 79 | Regionalny Szpital Specjalistyczny | Świdnica | Poland | ||
| 80 | nstituto Português de Oncologia Francisco Gentil | Lisbon | Portugal | ||
| 81 | Non-state Health Care Insitution "N.A. Semashko Central Clinical Hospital #2" of the "Russian Railways" Joint Stock Company | Moscow | Russian Federation | ||
| 82 | State Institution "N.N. Blokhin Russian Oncology Scientific Center" of the Russian Academy of Medical Sciences | Moscow | Russian Federation | ||
| 83 | State Science Institution "P.A. Hertzen Moscow Oncology Research Institute" of the Federal Agency of Health Care and Social Development | Moscow | Russian Federation | ||
| 84 | State Health Care Institution "Regional Clinical Oncology Dispensary" | Ryazan | Russian Federation | ||
| 85 | Municipal Health Care Institution of the City of Sochi "Oncology Dispensary" | Sochi | Russian Federation | ||
| 86 | St. Petersburg State Health Care Institution "City Clinical Oncology Dispensary" | St Petersberg | Russian Federation | ||
| 87 | 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 | ||
| 88 | 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 | ||
| 89 | State Health Care Institution "Leningrad Regional Oncology Dispensary" | St. Petersburg | Russian Federation | ||
| 90 | State Health Care Institution of the Yaroslavl Region "Yaroslavl Regional Oncology Dispensary" | Yaroslavl | Russian Federation | ||
| 91 | Hospital de la Santa Creu i Sant Pau | Barcelona | Spain | ||
| 92 | Hospital Universitario Vall d'Hebron | Barcelona | Spain | ||
| 93 | Hospital Universitari Arnau de Vilanova de Lleida | Lleida | Spain | ||
| 94 | Hospital 12 de Octubre | Madrid | Spain | ||
| 95 | Hospital Son Dureta | Palma de Mallorca | Spain | ||
| 96 | Hospital Clínico Universitario de Salamanca | Salamanca | Spain | ||
| 97 | Hospital Virgen Macarena | Sevilla | Spain | ||
| 98 | Hospital Mutua de Terrassa | Terrassa | Spain | ||
| 99 | Hospital Clínico Universitario de Valencia | Valencia | Spain | ||
| 100 | Hospital General Universitario de Valencia | Valencia | Spain | ||
| 101 | Hospital Clínico Universitario Lozano Blesa | Zaragoza | Spain | ||
| 102 | Broomfield Hospital | Broomfield | United Kingdom | ||
| 103 | Christie Hospital NHS Trust | Cardiff | United Kingdom | ||
| 104 | Guy's Hospital | London | United Kingdom | ||
| 105 | Royal Free Hospital | London | United Kingdom |
Sponsors and Collaborators
- Sopherion Therapeutics
Investigators
- Principal Investigator: Jose Baselga, M.D., Vall d'Hebron Hospital, Barcelona, Spain
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00294996
Other Study ID Numbers:
- STM01-102
First Posted:
Feb 22, 2006
Last Update Posted:
Mar 31, 2009
Last Verified:
Mar 1, 2009
Keywords provided by ,
,
Additional relevant MeSH terms: