Spots Global Cancer Trial Database for A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.
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Trial Identification
Brief Title: A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.
Official Title: A Randomized, Open Label Study to Compare the Complete Pathological Response Rate Achieved With 4 Combinations of Herceptin, Docetaxel and Pertuzumab in Patients With Locally Advanced, Inflammatory or Early Stage HER2 Positive Breast Cancer
Study ID: NCT00545688
Conditions
Study Description
Brief Summary: This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Geelong Hospital; Andrew Love Cancer Centre, Geelong, Victoria, Australia
Mount Medical Center, Perth, Western Australia, Australia
Kaiser Franz Josef Spital; Iii. Medizinische Abt. Mit Onkologie, Vienna, , Austria
Medizinische Universität Wien; Univ.Klinik für Innere Medizin I, Wien, , Austria
Hospital de Caridade de Ijui; Oncologia, Ijui, RS, Brazil
Hospital Nossa Senhora da Conceicao, Porto Alegre, RS, Brazil
Clinica de Neoplasias Litoral, Itajai, SC, Brazil
Hospital Amaral Carvalho, Jau, SP, Brazil
Faculdade de Medicina do ABC - FMABC; Oncologia e Hematologia, Santo Andre, SP, Brazil
Instituto do Cancer Arnaldo Vieira de Carvalho - ICAVC; Pesquisa Clinica, Sao Paulo, SP, Brazil
Hospital Perola Byington, Sao Paulo, SP, Brazil
Inst. Brasileiro de Controle Ao Cancer; Oncologia Clinica / Quimioterapia, Sao Paulo, SP, Brazil
Instituto de Oncologia de Sorocaba - CEPOS, Sorocaba, SP, Brazil
Moncton Hospital, Moncton, New Brunswick, Canada
Cancer Centre of Southeastern Ontario; Kingston General Hospital, Kingston, Ontario, Canada
University Health Network; Princess Margaret Hospital; Medical Oncology Dept, Toronto, Ontario, Canada
McGill University; Montreal General Hosptial; Oncology, Montreal, Quebec, Canada
CHU de Québec - Hôpital du Saint-Sacrement / ONCOLOGY, Quebec, , Canada
Hadassah Ein Karem Hospital; Oncology Dept, Jerusalem, , Israel
Meir Medical Center; Oncology, Kfar-Saba, , Israel
Sourasky / Ichilov Hospital; Dept. of Oncology, Tel Aviv, , Israel
Az. Osp. S. Orsola Malpighi; Istituto Di Oncologia Seragnoli, Bologna, Emilia-Romagna, Italy
Ospedale Regionale Di Parma; Divisione Di Oncologia Medica, Parma, Emilia-Romagna, Italy
Azienda Ospedaliero-Universitaria Dipartimento Interaziendale Di Oncologia, Udine, Friuli-Venezia Giulia, Italy
ASST OVEST MILANESE; Oncologia Medica, Legnano, Lombardia, Italy
Ospedale San Raffaele, Servizio di Oncologia e Chemioterapia, Milano, Lombardia, Italy
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 1, Milano, Lombardia, Italy
Ospedale Calvi di Noale; U.O. Complessa di Oncologia ed Ematologia Oncologica, Mirano, Veneto, Italy
Polo Ospedaliero Santorso, Santorso, Veneto, Italy
Ospedale Di Vicenza; Nefrologia, Oncologia Medica, Vicenza, Veneto, Italy
Seoul National Uni Hospital; Dept. of Internal Medicine/Hematology/Oncology, Seoul, , Korea, Republic of
Samsung Medical Centre; Division of Hematology/Oncology, Seoul, , Korea, Republic of
Hospital Miguel Hidalgo, Aguascalientes, , Mexico
ARKE Estudios Clínicos S.A. de C.V., Mexico City, , Mexico
Issstep Puebla, ; Oncology, Puebla, , Mexico
Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica, Arequipa, , Peru
Hospital Nacional Edgardo Rebagliati Martins; Oncologia, Lima, , Peru
Samodzielny Publiczny Kliniczny Nr 1 W Lublinie; Klinika Chirurgii Onkologicznej, Lublin, , Poland
COZL Oddzial Onkologii Klinicznej z pododdzialem Chemioterapii Dziennej, Lublin, , Poland
Olsztyński Ośrodek Onkologiczny Kopernik sp. z o.o., Olsztyn, , Poland
Oddzial Chemioterapii Szpitala Klinicznego Nr 1 w Poznaniu, Poznan, , Poland
NZOZ Centrum Medyczne HCP Sp. z o.o., Poznan, , Poland
Central Hospital of Military School of Medicine; Oncology, Warszawa, , Poland
Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii, Warszawa, , Poland
FSBI "Scientific Research Institute of Oncology named after N.N.Petrov" Ministry of Health of RF, St Petersburg, Leningrad, Russian Federation
SI of Healthcare Kazan Oncology Dispensary, Kazan, , Russian Federation
Russian Oncology Research Center n.a. N.N. Blokhin Dpt of Clinical Pharmacology and Chemotherapy, Moscow, , Russian Federation
NSI of Healthcare Central Clinical Hospital #2 n.a. N.A.Semashko of the Russian Railways, Moscow, , Russian Federation
State Institution Of Healthcare Republican Oncology Dispensary, Petrozavodsk, , Russian Federation
State Budget Institution of Healthcare of Stavropol region Pyatigorsk Oncology Dispensary, Pyatigorsk, , Russian Federation
SBI for HPE "Ryazan State Medical University n.a. I.P. Pavlov" of MoH of RF, Ryazan, , Russian Federation
SBI of Healthcare Samara Regional Clinical Oncology Dispensary, Samara, , Russian Federation
SI of HealthCare Oncologic Dispensary #2 of department of healthcare of Krasnodar region, Soshi, , Russian Federation
SBI of Healthcare Leningrad Regional Oncology Dispensary, St Petersburg, , Russian Federation
Ulyanovsk Regional Oncology Dispensary; Chemotherapy, Ulyanovsk, , Russian Federation
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia, Sabadell, Barcelona, Spain
Hospital de Cruces; Servicio de Oncologia, Barakaldo, Vizcaya, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia, Cordoba, , Spain
Hospital General Universitario Gregorio Marañon; Servicio de Oncologia, Madrid, , Spain
Hospital Ramon y Cajal; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario La Paz; Servicio de Oncologia, Madrid, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia, Valencia, , Spain
Hospital Universitario Miguel Servet; Servicio Oncologia, Zaragoza, , Spain
Karolinska Hospital; Oncology - Radiumhemmet, Stockholm, , Sweden
Akademiska sjukhuset, Onkologkliniken, Uppsala, , Sweden
Kantonsspital Baden; Frauenklinik, Baden, , Switzerland
Brustzentrum, Zürich, , Switzerland
VETERANS GENERAL HOSPITAL; Department of General Surgery, Taipei, , Taiwan
National Taiwan Uni Hospital; Dept of Oncology, Taipei, , Taiwan
Koo Foundation Sun Yat-Sen Cancer Center; Hemato-Oncology, Taipei, , Taiwan
Chulalongkorn Hospital; Medical Oncology, Bangkok, , Thailand
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology, Bangkok, , Thailand
Prince of Songkla Uni ; Unit of Medical Oncology, Songkhla, , Thailand
Dokuz Eylul Uni Medical Faculty; Oncology Dept, Izmir, , Turkey
Hacettepe Uni Medical Faculty Hospital; Oncology Dept, Sıhhiye, ANKARA, , Turkey
Walsgrave Hospital; Dept of Oncology, Coventry, , United Kingdom
Christie Hospital; Breast Cancer Research Office, Manchester, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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