BETH Study: Treatment of HER2 Positive Breast Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab (BETH)

September 9, 2020 updated by: NSABP Foundation Inc

A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients With HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab With Chemotherapy Plus Trastuzumab Plus Bevacizumab

The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer.

Study Overview

Status

Terminated

Conditions

Breast Cancer

Intervention / Treatment

Detailed Description

This Phase III, randomized, open-label trial will determine whether the regimens of chemotherapy plus trastuzumab plus bevacizumab improve invasive disease-free survival (IDFS) relative to the regimens of chemotherapy plus trastuzumab. Secondary aims include determining whether the addition of bevacizumab to chemotherapy plus trastuzumab will improve disease-free survival (DFS), overall survival (OS), recurrence-free interval (RFI), and distant recurrence-free interval (DRFI). The benefit of adding bevacizumab for IDFS, DFS, OS, RFI, and DRFI will also be evaluated for each of the two chemotherapy regimens. The cardiac and non-cardiac toxicities of each of the regimens will also be evaluated.

Following local determination that the tumor is HER2-positive for gene amplification by in situ hybridization or is IHC 2+ or 3+, a tumor sample must be submitted for HER2 testing by a designated central laboratory. If central testing confirms that the tumor is HER2-positive (either positive by FISH or IHC 3+) and all other eligibility criteria have been met, the patient will be randomized to a regimen of chemotherapy and trastuzumab with or without bevacizumab.

Patients in the trial will be enrolled in one of two chemotherapy regimen cohorts. One cohort will receive 6 cycles of docetaxel/carboplatin plus trastuzumab (TCH) with or without bevacizumab; the other cohort will receive 3 cycles of docetaxel plus trastuzumab given with or without bevacizumab followed by 3 cycles of 5-Fluorouracil, Epirubicin, Cyclophosphamide (TH-FEC). With both regimens, patients will continue trastuzumab with or without bevacizumab following chemotherapy to complete 1 year of targeted therapy. Following completion of chemotherapy, patients will also receive adjuvant radiotherapy and endocrine therapy as clinically indicated.

The trial will be conducted by investigators affiliated with the Cancer International Research Group (CIRG) and the National Surgical Adjuvant Breast and Bowel Project (NSABP). CIRG and NSABP investigators will only enroll patients in the TCH regimen cohort. Additional investigators, referred to in the protocol as Independent Investigators, will enroll patients in both the TCH regimen or the TH-FEC regimen cohort depending on institutional preference for the one regimen that will be used by that institution for the duration of the trial.

Patients will be given the option of allowing their tumor samples to be used for the BETH translational research and correlative science studies. Also, patients will be asked to consent to the submission of blood and serum samples at scheduled time points during the study.

LVEF assessments will be performed before study entry and then at scheduled time points during therapy and at 18, 36, and 60 months following randomization.

The planned sample size for the trial is 3,000 patients randomized in the faster accruing cohort and a minimum of 3,500 patients overall.

Study Type

Interventional

Enrollment (Actual)

3509

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1431FWO
    - CEMIC
  - Buenos Aires, Argentina, C1280AEB
    - Hospital Británico de Buenos Aires
- Buenos Aires
  - Derqui, Buenos Aires, Argentina, B1629ODT
    - Hospital Universitario Austral
  - La Plata, Buenos Aires, Argentina, B1902CMV
    - Breast Clinica de la Mama
- Sante Fe
  - Rosario, Sante Fe, Argentina, S2000DSK
    - Centro Oncologico Rosario (COR)
Australia
- New South Wales
  - Campbelltown, New South Wales, Australia, 2560
    - Macarthur Cancer Center
  - Kogarah, New South Wales, Australia, 2217
    - St. George Hospital
  - Liverpool, New South Wales, Australia, 1871
    - Cancer Therapy Center
  - St. Leonards, New South Wales, Australia, 2065
    - Royal North Shore Hospital
  - St. Leonards, New South Wales, Australia, 2065
    - North Shore Private Hospital
  - Wollongong, New South Wales, Australia, 2500
    - Southern Medical Day Care
- Queensland
  - Herston, Queensland, Australia, 4029
    - Royal Brisbane & Women's Hospital
  - South Brisbane, Queensland, Australia, 4101
    - Mater Adult Hospital
- South Australia
  - Ashford, South Australia, Australia, 5035
    - Ashford Cancer Center
  - Bedford, South Australia, Australia, 5042
    - Flinders Medical Centre
- Victoria
  - Frankston, Victoria, Australia, 3199
    - Frankston Hospital
  - Melbourne, Victoria, Australia, 3004
    - The Alfred Hospital
- Western Australia
  - Perth, Western Australia, Australia, 6000
    - Mount Medical Center
  - Subiaco, Western Australia, Australia, 6008
    - Berdat Family Comprehensive Cancer Centre
Austria
- - Graz, Austria, 8020
    - Krankenhaus Barmherzige Brueder Graz, Medizinische Abteilung
  - Graz, Austria, 8036
    - Universitatsfrauenklinik Graz
  - Graz, Austria, A-8036
    - Medizinische Universitat Graz - Onkologie
  - Innsbruck, Austria, A-6020
    - AI University Hospital Innsbruck
  - Kufstein, Austria, 6330
    - Bezirkskrankenhaus Kufstein, Innere Medizin
  - Leoben, Austria, 8700
    - Landeskrankenhaus Leoben, Abteilung fur Haemato-Onkologie
  - Linz, Austria, 4010
    - Krankenhaus Barmherzige Schwestern Linz, Kooperative Studiengruppe, Chirurgie
  - Salzburg, Austria, 5020
    - AI Universitätsklinikum der PMU Landeskliniken
  - Vienna, Austria, 1090
    - AKH Vienna
  - Vienna, Austria, 1090
    - Medizinische Universitaet Wien-Allgemeines Krankenhaus, Onkologie
  - Vienna, Austria, 1130
    - Krankenhaus Hietzing, Gynaekologische Abteilung
  - Voecklabruck, Austria, 4840
    - Landeskrankenhaus Voecklabruck, 2. Medizinische Abteilung
  - Wels, Austria, 4600
    - Klinikum Wels-Grieskirchen, Kooperative Gruppe Wels/4. Medizinische Abteilung
Belgium
- - Brasschaat, Belgium, 2930
    - AZ Klina
  - Charleroi, Belgium, 6000
    - C. H. Notre-Dame and Reine Fabiola
  - Ottignies, Belgium, 1340
    - Clinique St Pierre
  - Wilrijk, Belgium, 2610
    - Medical Institute St. Augustinus
Bosnia and Herzegovina
- - Sarajevo, Bosnia and Herzegovina, 71000
    - Clinical Centre University of Sarajevo
Brazil
- - Sorocaba, Brazil, 18030-075
    - Conjunto Hospitalar de Sorocaba
- GO
  - Goiania, GO, Brazil, 74075-040
    - Centro Goiano de Oncologia
- MG
  - Belo Horizonte, MG, Brazil, 30110-090
    - Lifecenter Sistema de Saude S/A
- RJ
  - Rio de Janeiro, RJ, Brazil, 20560-120
    - Instituto Nacional de Câncer
  - Rio de Janeiro, RJ, Brazil, 22260-020
    - Clinica Oncologistas Associados
- RS
  - Ijui, RS, Brazil, 98700-000
    - Assoiacao hospital de caridade de ijui
  - Porto Alegre, RS, Brazil, 90035-003
    - Hospital Das Clinicas de Porto Alegre-HCPA
  - Porto Alegre, RS, Brazil, 90050-170
    - Irmandade da Santa Casa de Misericoria de Porto Alegre Nucleo de Novos Tratamentos
  - Porto Alegre, RS, Brazil, 90430-090
    - Clínica de Oncologia de Porto Alegre
- SP
  - Jau, SP, Brazil, 17210-080
    - Fundacao Dr. Amaral Carvalho
  - Piracicaba, SP, Brazil, 13419-155
    - Instituto de Oncologia Clínica de Piracicaba
  - Santo Andre, SP, Brazil, 09060-650
    - Centro de Oncologia e Hematologia da Faculdade de Medicina do ABC
  - Sao Paulo, SP, Brazil, 01246-000
    - Instituto do Câncer de São Paulo
Bulgaria
- - Plovdiv, Bulgaria, 4000
    - District Oncology Dispensary Plovdiv
  - Sofia, Bulgaria, 1527
    - MHAT "Tsaritsa Yoanna-ISUL" EOOD
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Centre
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute, Dept of Medicine
- British Columbia
  - North Vancouver, British Columbia, Canada, V7L 2L7
    - Lion's Gate Hospital
- Newfoundland and Labrador
  - St. Johns, Newfoundland and Labrador, Canada, AIB 3V6
    - Dr. H. Bliss Murphy Cancer Centre
- Ontario
  - Brampton, Ontario, Canada, L6R 3J7
    - William Osler Health Center
  - Mississauga, Ontario, Canada, L5M 2N1
    - Credit Valley Hospital
  - New Market, Ontario, Canada, L3Y 2P9
    - Southlake Regional Health Centre
  - Ottawa, Ontario, Canada, K1H 8L6
    - Ottawa Hospital Regional Cancer Centre
  - Toronto, Ontario, Canada, M5B 1W8
    - St. Michaels Hospital
  - Weston, Ontario, Canada, M9N 1N8
    - Humber River Regional Hospital
  - Windsor, Ontario, Canada, N8W 2X3
    - Windsor Regional Cancer Centre
- Quebec
  - Greenfield Park, Quebec, Canada, J4V 2H1
    - Hopital Charles LeMoyne
  - Montreal, Quebec, Canada, H3T 1E2
    - Jewish General Hospital
  - Montreal, Quebec, Canada, H3A 1A1
    - Royal Victoria Hospital
  - Montreal, Quebec, Canada, H3G 1A4
    - Montreal General Hospital
  - Montreal, Quebec, Canada, H1T 2M4
    - Hôpital Maisonneuve Rosemont
  - Montreal, Quebec, Canada, H4J 1C5
    - Hospital du Sacre-Coeur
  - Montreal, Quebec, Canada
    - University of Montreal Hospital Group
  - Quebec City, Quebec, Canada, G1S 4L8
    - Centre Hospitalier Affilie Universitaire De Quebec, Hospital du St-Sacrement
Chile
- VI Region
  - Rancagua, VI Region, Chile, 2820000
    - Hospital Regional Rancagua
China
- - Beijing, China, 100853
    - Chinese PLA General hospital
  - Beijing, China, 100021
    - Chinese Academy of Medical Science
  - Beijing, China, 100071
    - The PLA 307 Hospital
  - Changchun, China, 130012
    - Jilin Cancer Hospital
  - Chengdu, China, 610041
    - West China Hospital, Sichuan University
  - Fuzhou, China, 354200
    - Fuzhou General Hospital of Nanjing Military Area
  - Guangzhou, China, 510060
    - Sun Yat-sen University Hospital
  - Hangzhou, China, 310003
    - 1st Affiliated Hospital of Zhejiang University
  - Hangzhou, China, 310022
    - Zhejiang Tumor Hospital
  - Tianjin, China, 300060
    - Tianjin Cancer Hospital
Croatia
- - Zagreb, Croatia, 10000
    - University Hospital Zagreb
Czechia
- - Praha 8, Czechia, 180 81
    - FN Na Bulovce
Egypt
- - Cairo, Egypt, 11796
    - National Cancer Institute
Estonia
- - Tartu, Estonia, 51014
    - Tartu University Hospital Clinic of Hematology and Oncology
France
- - Amiens, France, 80054
    - CHU d'Amiens
  - Beauvais, France, 60000
    - CH-Service Hemato-Oncologie
  - Bordeaux, France, 33300
    - Clinique Bordeaux Nord Aquitaine
  - Brest, France, 29609
    - CHU Morvan
  - Colmar, France, 68024
    - Hopital Pasteur
  - Creteil, France, 94000
    - CH intercommunal de Créteil
  - Dechy, France, 59187
    - Centre Leonard de Vinci
  - Grenoble, France, 38028
    - Institut Daniel Hollard
  - La Roche sur Yon Cedex, France, 85925
    - CHD Les Oudairies
  - Limoges, France, 87042
    - Chu Dupuytren
  - Limoges, France, 87039
    - Clinique Francois Chenieux
  - Marseille, France, 13008
    - Hôpital St. Joseph
  - Montpellier, France, 34298
    - Centre Regional de Lutte contre le Cancer (CRLC) Val d'Aurelle
  - Nantes Cedex, France, 44202
    - Centre Catherine de Sienne
  - Neuilly sur Seine, France, 92200
    - Clinique Hartmann
  - Paris, France, 75004
    - CHU Hôtel Dieu
  - Paris Cedex 12, France, 75571
    - Hopital St. Antoine
  - Rouen, France, 76000
    - Clinique Saint Hilaire
  - Strasbourg, France, 67000
    - Pole de cancerologie prive
  - Strasbourg, France, 67085
    - CLCC Paul Strauss
  - Toulous, France, 31400
    - Polyclinique du Parc
  - Toulouse Cedex, France, 31052
    - Institution Claudius Regaud
Germany
- - Amberg, Germany, 92224
    - Klinikum St. Marien Amberg
  - Bad Nauheim, Germany, 61231
    - Hochwaldkrankenhaus
  - Böeblingen, Germany, 71032
    - Klinikverbund Suedwest - Sindelfingen-Böeblingen Clinical Centre
  - Chemnitz, Germany, 09116
    - Klinikum Chemnitz
  - Dresden, Germany, 01307
    - Universitaetsklinikum Dresden
  - Duesseldorf, Germany, 40235
    - Luisenkrankenhaus
  - Essen, Germany, 45122
    - Universitaetsfrauenklinik
  - Frankfurt, Germany, D-60590
    - Zentrum fur Frauenheilkunde und Geburtshilfe
  - Fulda, Germany, 36043
    - Medizinisches Versorgungszentrum Osthessen
  - Hameln, Germany, 31785
    - Kreiskrankenhaus Hameln
  - Hanau, Germany, 63450
    - Klinikum Stadt Hanau
  - Hannover, Germany, 30167
    - Klinikum Hannover Nordstadt
  - Jena, Germany, 07743
    - Universitat Frauenklinik Jena
  - Leer, Germany, 26789
    - Onkologische Schwerpunktpraxis
  - Lemgo, Germany, D-32657
    - Klinikum Lippe Lemgo
  - Lich, Germany, 35423
    - Asklepios Kliniken Lich GmbH
  - Mainz, Germany, 55101
    - Universitaetsklinikum Mainz
  - Mainz, Germany, 55131
    - St. Vincenz u. Elisabeth Hospital
  - Munich, Germany, 80637
    - RotKreuzKlinikum München GmbH
  - Munster, Germany, 48129
    - Universitaetsklinikum Munster
  - Mönchengladbach, Germany, 41061
    - Ev Krankenhaus Bethesda
  - Recklinghausen, Germany, 45657
    - Praxis und Tagesklinik fuer Onkologie und
  - Rosenheim, Germany, 83022
    - Klinikum Rosenheim
  - Stadhagen, Germany, 31655
    - Klinikum Schaumburg
  - Stendal, Germany, D-39576
    - Johanniter Krankenhaus
  - Stuttgart, Germany, 70376
    - Robert-Bosch-Krankenhaus
  - Traunstein, Germany, 83278
    - Fachärzte fürlnnere Medizin, Hämatologie
Greece
- - Thessaloniki, Greece, 56429
    - P.G. Hospital of Thessaloniki "Papageorgiou"
Hong Kong
- - Hong Kong, Hong Kong
    - Prince of Wales Hospital
  - Hong Kong, Hong Kong
    - Queen Elizabeth Hospital
Hungary
- - Budapest, Hungary, 1082
    - Semmelweis Egyetem Clinic of Radiology
  - Debrecen, Hungary, 4012
    - DEOEC Onkologiai Tanszek
  - Gyor, Hungary
    - Petz Aladar Megyei Oktato
  - Kaposvar, Hungary, H-7400
    - Kaposi Mor oktato korhaz Onkologiai tanszek
Ireland
- - Cork, Ireland
    - Cork University Hospital
  - Dublin, Ireland, 8
    - St. James's Hospital
  - Dublin, Ireland
    - Mater Private Hospital
  - Dublin, Ireland, 0009
    - Beaumont Hospital
  - Dublin, Ireland
    - Adelaide and Meath National Childrens Hospital
  - Dublin, Ireland
    - Institute for Cancer Research
  - Dublin 4, Ireland
    - St. Vincent's University Hospital
  - Galway, Ireland
    - University College Hospital Galway
  - Limerick, Ireland
    - Midwestern Regional Hospital
  - Sligo, Ireland
    - Sligo General Hospital
Israel
- - Haifa, Israel
    - The Lady Davis Carmel Medical Center/Lynn
  - Kfar, Israel, 13100
    - Meir Medical Center
  - Rehovot, Israel
    - Kaplan Medical Center
  - Tel Aviv, Israel
    - Sourasky (Ichilov) Medical Center
  - Zefat, Israel
    - Ziv Medical Center
  - Zerifin, Israel
    - Assaf Harofeh Medical Center
Italy
- - Catania, Italy, 95126
    - Humanitas Centro Catanese
  - Chieti, Italy, 66100
    - (Azienda u.s.I. chieti) - Policinico Ospedaliero
  - Lecce, Italy
    - Ospedale Vito Fazzi
  - Mirano, Italy
    - Ospedale di Mirano
  - Napoli, Italy, 80131
    - IRCCS - Instituto Nazionale per lo Studio e la Cura
  - Pavia, Italy, 27100
    - Fondazione Salvatore Maugeri
  - Roma, Italy, 00135
    - Ospedale S. Filippo Neri
  - Rome, Italy
    - Regina Elena Cancer Institute
  - San-Giovanni, Italy
    - Ospedale Casa Sollievo della Sofferenza
  - Sassari, Italy, 07100
    - Universita-istituto Clinica Medica
  - Taormina, Italy
    - Asl n. 5 -Ospedale s. Vincenzo
Korea, Republic of
- - Gyeonggi-do, Korea, Republic of, 463-707
    - Seoul National University Bundang Hospital
  - Seoul, Korea, Republic of, 135-710
    - Samsung Medical Center
  - Seoul, Korea, Republic of, 138-736
    - Asan Medical Center
  - Seoul, Korea, Republic of, 110-744
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 120-752
    - Severance Hospital
Latvia
- - Riga, Latvia
    - P. Stradina Clinical University Hospital
Mexico
- - Monterrey, Mexico, 64060
    - Opcion Oncologia
Peru
- - Arequipa, Peru
    - Hospital Nacional Carlos Alberto Seguin
  - Lima, Peru, LIMA 11
    - Hospital Nacional Edgardo Rebagliati Martins
Philippines
- - Cebu City, Philippines, 6000
    - Cebu Doctors University Hospital
Poland
- - Bialystok, Poland
    - Regional Oncology Center
  - Gliwice, Poland, 44-101
    - Centrum Onkologii Instytut im. M.
  - Olsztyn, Poland, 10-513
    - Olsztynski Osrodek Onkologiczny "Kopernik"
  - Olsztyn, Poland, 10-228
    - ZOZ MSWiA z Warminsko-Mazurskim Centrum
  - Rybnik, Poland, 44-200
    - Samodzielny Publiczny Zaklad Opieki
  - Warsaw, Poland, 02-781
    - Breast Cancer Clinic
Portugal
- - Coimbra, Portugal, 3000-073
    - HUC
  - Porto, Portugal, 4200-319
    - IPO Francisco Gentil-Porto
Romania
- - Alba-Iulia, Romania, 510000
    - County Hospital Alba-Iulia
  - Bucharest, Romania, 022338
    - Institute of Oncology "AI.Trestioreanu"
  - Cluj-Napoca, Romania
    - Institutul Oncologic "Prof. Dr. I. Chiricuta" Cluj-Napoca
Russian Federation
- - Kazan, Russian Federation
    - State Medical Institution "Republican Clinical Oncology Dispensary Ministry of Health of Republic Tatarstan"
  - Moscow, Russian Federation
    - State Institution "Russian Oncological Research Center n.a. N.N. Blokhin of RAMS"
  - Saint Petersburg, Russian Federation
    - Federal State Institution "Research Institute of Oncology n.a. N.N. Petrov Rosmedtechnologiy"
  - Saint Petersburg, Russian Federation
    - Saint-Petersburg State Medical Institution "City Clinical Oncology Dispensary"
Serbia
- - Belgrade, Serbia, 11080
    - Clinical Hospital Center Bezanijska Kosa
  - Nis, Serbia, 18000
    - Clinic of Oncology, Clinical Center nis
Slovenia
- - Maribor, Slovenia, 2101
    - University Clinical Centre
South Africa
- - Bloemfontein, South Africa, 9301
    - Department of Oncotherapy National Hospital
  - Durban, South Africa, 4001
    - Hopelands Cancer Centre
  - Johannesburg, South Africa
    - Johannesburg Hospital
Spain
- - Alcorcon, Spain, 28922
    - Fundacion Hospitalaria de Alcorcon
  - Alicante, Spain, 03010
    - Hospital General de Alicante
  - Badajoz, Spain, 6010
    - Hospital Perpetuo Socorro
  - Badalona (Barcelona), Spain, 08916
    - Hospital Germans Trias l Pujol
  - Barbastro, Spain, 22300
    - Hospital Comarcal de Barbastro
  - Barcelona, Spain, 08003
    - Hospital del Mar
  - Barcelona, Spain, 08036
    - Hospital Clinic I Provincial
  - Barcelona, Spain, 08227
    - Consorci Sanitari de Terrassa
  - Barcelona, Spain, 08025
    - Hospital Santa Crue l San Pau
  - Barcelona, Spain, 08243
    - ALTHAIA Xarxa Assistencial de Manresa
  - Barcelona, Spain, 08923
    - Hospital Espíritu Santo
  - Caceres, Spain, 10003
    - Hospital de San Pedro de Alcantara
  - Elche, Spain, 03202
    - Hospital Gral. De Elche
  - Gijon, Spain, 33394
    - Hospital de Cabueñes, Oncologia Médica
  - Girona, Spain, 17007
    - Instituto Catalan Oncologia de Girona
  - Jaen, Spain, 23007
    - Complejo Hospitalario de Jaén
  - La Coruna, Spain, 15006
    - Complejo Hospitalario Universitario A Coruna
  - La Coruña, Spain, 15009
    - Centro Oncológico de Galicia
  - La Laguna, Spain, 38320
    - Hospital Universitario de Canarias
  - Lugo, Spain
    - Hospital Xera Calde
  - Madrid, Spain, 28040
    - Fundacion Jimenez Diaz
  - Madrid, Spain, 28040
    - Hospital Universitario San Carlos
  - Madrid, Spain, 28007
    - Hospital Universitario Gregorio Marañon
  - Madrid, Spain, 28034
    - Hospital Ruber International
  - Madrid, Spain, 28050
    - Centro Integral de Oncologia "Clara Campal"
  - Malaga, Spain, 29010
    - Hospital Clínico Virgen de la Victoria
  - Malaga, Spain, 29010
    - Hospital Univesitario Carlos Haya
  - Ourense, Spain
    - Hospital Santa Maria Nai Dr. Cabaleiro
  - Pontevedra, Spain, 36001
    - Complejo Hospitalario de Pontevedra
  - Sabadell, Spain, 08208
    - Hospital del Parc Tauli
  - Salamanca, Spain, 37007
    - Hospital Universitario de Salamanca
  - San Sebastian, Spain
    - Instituto Oncológico de Guipúzcoa
  - Sevilla, Spain, 41013
    - Hospital Universitario Virgen del Rocío
  - Torrevieja, Spain, 03186
    - Hospital Torrevieja Salud, UTE
  - Valencia, Spain, 46010
    - Hospital Clinico Universitario de Valencia
  - Zaragoza, Spain, 50009
    - Hospital Clinico Universitario Lozano Blesa
  - Zaragoza, Spain, 50009
    - Hospital U. Miguel Servet
- Canary Islands
  - Las Palmas, Canary Islands, Spain, 33106
    - Hospital Universitario Insular de Gran Canaria
Sweden
- - Goteborg, Sweden, 41345
    - Sahlgrenska University Hospital
  - Stockholm, Sweden, S-118
    - Karolinska University Hospital
Taiwan
- - Changhua, Taiwan, 500
    - Changhua Christian Hospital
  - Kaohsiung, Taiwan, 807
    - Kaohsiung Medical University Chung
  - Tainan, Taiwan, 704
    - National Cheng Kung University
  - Taipei, Taiwan, 112
    - Taipei Veterans General Hospital
  - Taipei, Taiwan, 112
    - Sun Yat-Sen Cancer Center
  - Taoyuan, Taiwan, 3330
    - Chang Gung Memorial Hospital
Thailand
- - Bangkok, Thailand, 10400
    - National Cancer Institute
  - Songkhla, Thailand
    - Songklanagarind hospital
- Bangkok
  - Patumwan, Bangkok, Thailand, 10330
    - Chulalongkorn Hospital
United Kingdom
- - Bournemouth, United Kingdom, BH7 7DW
    - Royal Bournemouth Hospital
  - Bristol, United Kingdom, BS2 8ED
    - Bristol Hematology - Oncology Centre
  - Ipswich, United Kingdom, IP4 5PD
    - Ipswich Hospital
  - Manchester, United Kingdom, M20 4BX
    - Christie Hospital NHS Trust
  - Nottingham, United Kingdom, NG5 1PB
    - Nottingham City Hospital
  - Peterborough, United Kingdom, PE3 6DA
    - Peterborough District Hospital
  - Truro, United Kingdom, TR1 3IJ
    - Sunrise Cancer Centre
United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - University of Alabama at Birmingham
  - Decatur, Alabama, United States, 35601
    - Clearview Cancer Institute-Decatur
  - Huntsville, Alabama, United States, 35805
    - Clearview Cancer Institute- Huntsville
  - Huntsville, Alabama, United States, 35801
    - Clearview Cancer Institute
- Arizona
  - Flagstaff, Arizona, United States, 86001
    - Northern Arizona Hematology & Onclogy Associates
  - Sedona, Arizona, United States, 86336
    - Northern Arizona Hematology & Oncology Associates
- California
  - Alhambra, California, United States, 91801
    - Central Hematology/Oncology Medical Group, Inc.
  - Bakersfield, California, United States, 93309
    - Comprehensive Blood And Cancer Center
  - Baldwin Park, California, United States, 91706
    - Kaiser Permanente-Baldwin Park
  - Bellflower, California, United States, 90706
    - Kaiser Permanente-Bellflower
  - Burbank, California, United States, 91505
    - Providence Saint Joseph Medical Center
  - Encinitas, California, United States, 92024
    - Hematology-Encinitas
  - Encinitas, California, United States, 92024
    - Scripps Clinic Encinitas
  - Fontana, California, United States, 92335
    - Kaiser Permanente-Fontana
  - Fullerton, California, United States, 92835
    - St. Jude Heritage Healthcare
  - Hawthorne, California, United States, 90250
    - Breastlink Medical Group, Inc
  - Huntington Beach, California, United States, 92648
    - Pacific Shores Medical Group
  - Irvine, California, United States, 92618
    - Kaiser Permanente-Irvine
  - La Jolla, California, United States, 92037
    - Hematology-La Jolla
  - La Jolla, California, United States, 92037
    - Sabina R. Wallach, MD., AMC
  - La Jolla, California, United States, 92037
    - Scripps Cancer Center-San Diego
  - Lancaster, California, United States, 93534
    - Antelope Valley Cancer Center
  - Los Angeles, California, United States, 90034
    - Kaiser Permanente-West Los Angeles
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente-Sunset
  - Oakland, California, United States, 94611
    - Kaiser Permanente-Oakland
  - Oceanside, California, United States, 92056
    - North County Oncology Medical Clinic, Inc.
  - Panorama City, California, United States, 91042
    - Kaiser Permanente-Panorama City
  - Panorama City, California, United States, 92807
    - Kaiser Permanente-Orange County
  - Pasadena, California, United States, 91750
    - Wilshire Oncology Medical Group
  - Redondo Beach, California, United States, 90277
    - Cancer Care Associates Medical Group, Inc.
  - Riverside, California, United States, 92505
    - Kaiser Permanente-Riverside
  - Roseville, California, United States, 95661
    - Kaiser Permanente-Roseville
  - Roseville, California, United States, 95661
    - Sutter Roseville Medical Center
  - Roseville, California, United States, 95825
    - Kaiser Permanente-Sacramento
  - Sacramento, California, United States, 95816
    - Sutter Medical Group
  - Sacramento, California, United States, 95816
    - Sutter Medical Center
  - San Diego, California, United States, 92123
    - Sharp Rees-Stealy
  - San Diego, California, United States, 92120
    - Kaiser Permanente-San Diego
  - San Diego, California, United States, 92103
    - Peter T. Reissman, MD, Inc
  - San Diego, California, United States, 92103
    - William Stanton, MD, Inc
  - San Diego, California, United States, 92128
    - Scripps Clinic-Rancho Bernardo
  - San Francisco, California, United States, 94115
    - Kaiser Permanente-San Francisco
  - San Francisco, California, United States, 94545
    - Kaiser Permanente-Hayward
  - Santa Barbara, California, United States, 93105
    - Sansum Clinic
  - Santa Barbara, California, United States, 93105
    - Santa Barbara Hematology Oncology Medical Group
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente-Santa Clara
  - Santa Maria, California, United States, 93454
    - Central Coast Medical Oncology Corporation
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente-South San Francisco
  - Stanford, California, United States, 94305
    - Stanford University Medical Center
  - Valencia, California, United States, 91355
    - UCLA/Santa Clarita Valley Cancer Center
  - Vallejo, California, United States, 94589
    - Kaiser Permanente-Vallejo
  - Vista, California, United States, 92803
    - San Diego Pacific Oncology & Hematology-Vista
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente-Walnut Creek
  - Woodland Hills, California, United States, 91367
    - Kaiser Permanente-Woodland Hills
- Colorado
  - Aurora, Colorado, United States, 80045
    - University of Colorado Cancer Center
  - Colorado Springs, Colorado, United States, 80907
    - Penrose Cancer Center
  - Denver, Colorado, United States, 80205
    - Kaiser Permanente-Franklin
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Center - Midtown
  - Denver, Colorado, United States, 80210
    - Cypress Hematology/Oncology
  - Denver, Colorado, United States, 80224
    - CCOP-Colorado Cancer Research Prog. Inc.(Administrative Only)
  - Edwards, Colorado, United States, 81632
    - Shaw Regional Cancer Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Lafayette, Colorado, United States, 80026
    - Kaiser Permanente Rock Creek
  - Loveland, Colorado, United States, 80538
    - McKee Medical Center
  - Wheat Ridge, Colorado, United States, 80033
    - Exempla Lutheran Medical Center
- Connecticut
  - Avon, Connecticut, United States, 06001
    - Oncology Associates P.C.-Avon
  - Bridgeport, Connecticut, United States, 06610
    - Bridgeport Hospital
  - Bridgeport, Connecticut, United States, 06606
    - Medical Specialists of SWIM
  - Fairfield, Connecticut, United States, 06824
    - Medical Specialists of Fairfield
  - Fairfield, Connecticut, United States, 06824
    - Oncology Associates of Bridgeport-Fairfield
  - Hartford, Connecticut, United States, 06102
    - Hartford Hospital
  - Hartford, Connecticut, United States, 06106
    - Connecticut Multi Specialty Group-Hartford
  - Hartford, Connecticut, United States, 06106
    - Oncology Associates P.C.-Hartford
  - Meriden, Connecticut, United States, 06451
    - Medical Oncology and Hematology, P.C.
  - Norwich, Connecticut, United States, 06360
    - Eastern Connecticut Hematology & Oncology Associates
  - Trumbull, Connecticut, United States, 06611
    - Black Rock Medical Group
  - Trumbull, Connecticut, United States, 06611
    - Oncology Associates of Bridgeport-Trumbull
  - Waterbury, Connecticut, United States, 06708
    - Medical Oncology & Hematology, P.C.
  - Wethersfield, Connecticut, United States, 06109
    - Connecticut Multi Specialty Group-Wethersfield
  - Willimantic, Connecticut, United States, 06226
    - Oncology Associates P.C.-Willimantic
- Delaware
  - Newark, Delaware, United States, 19718
    - CCOP, Christiana Care Health Services Inc.
- District of Columbia
  - Washington, District of Columbia, United States, 20016
    - Sibley Memorial Hospital
  - Washington, District of Columbia, United States, 20010
    - Washington Cancer Institute
  - Washington, District of Columbia, United States, 20037
    - Washington Oncology-Hematology Center, PC-Washington
- Florida
  - Boca Raton, Florida, United States, 33428
    - Lynn Cancer Institute
  - Bonita Springs, Florida, United States, 34135
    - Florida Cancer Specialists-Bonita Springs
  - Bradenton, Florida, United States, 34209
    - Florida Cancer Specialists-Bradenton
  - Brandon, Florida, United States, 33511
    - Florida Cancer Specialists, Brandon
  - Cape Coral, Florida, United States, 33914
    - Florida Cancer Specialists-Cape Coral Parkway
  - Cape Coral, Florida, United States, 33990
    - Florida Cancer Specialists-Cape Coral Del Prado
  - Clearwater, Florida, United States, 33756
    - Florida Cancer Specialists
  - Englewood, Florida, United States, 34223
    - Florida Cancer Specialists-Englewood
  - Fort Myers, Florida, United States, 33901
    - Florida Cancer Specialists-Fort Myers Broadway
  - Fort Myers, Florida, United States, 33908
    - Florida Cancer Specialists-Fort Myers Summerlin
  - Gainesville, Florida, United States, 32605
    - Robert R. Carroll, MD, PA
  - Jacksonville, Florida, United States, 32258
    - Integrated Community Oncology Network
  - Lakeland, Florida, United States, 33805
    - Lakeland Regional Cancer Center
  - Naples, Florida, United States, 34102
    - Florida Cancer Specialists-Naples Goodlette
  - Naples, Florida, United States, 34119
    - Florida Cancer Specialists-NAPA Ridge
  - Orange Park, Florida, United States, 32073
    - Integrated Community Oncology Network
  - Orlando, Florida, United States, 32804
    - Florida Hospital Cancer Institute
  - Palm Harbor, Florida, United States, 34684
    - Florida Cancer Specialists, Cornerstone
  - Port Charlotte, Florida, United States, 33980
    - Florida Cancer Specialists-Port Charlotte
  - Saint Petersburg, Florida, United States, 33756
    - Florida Cancer Specialists-Park Place
  - Sarasota, Florida, United States, 34232
    - Florida Cancer Specialist-Cattleman
  - Sarasota, Florida, United States, 34236
    - Florida Cancer Specialists-Downtown
  - Tampa, Florida, United States, 33603
    - Florida Cancer Specialists
  - Tampa, Florida, United States, 33614
    - Florida Cancer Specialists
  - Venice, Florida, United States, 34285
    - Florida Cancer Specialists-Venice Island
  - Venice, Florida, United States, 34292
    - Florida Cancer Specialists-Venice
  - West Palm Beach, Florida, United States, 33401
    - Palm Beach Cancer Institute
- Georgia
  - Albany, Georgia, United States, 31701
    - Phoebe Putney Memorial Hospital
  - Athens, Georgia, United States, 30607
    - Northeast Georgia Cancer Care, LLC
  - Atlanta, Georgia, United States, 30322
    - Emory University
  - Atlanta, Georgia, United States, 30303
    - Grady Healthsystem
  - Augusta, Georgia, United States, 30901
    - Augusta Oncology Associates
  - Austell, Georgia, United States, 30106
    - Northwest Georgia Oncology Centers Pc
  - Carrollton, Georgia, United States, 30117
    - Northwest Georgia Oncology Centers Pc
  - Cartersville, Georgia, United States, 30121
    - Northwest Georgia Oncology Centers Pc
  - Lawrenceville, Georgia, United States, 30045
    - Suburban Hematology-Oncology Associates
  - Macon, Georgia, United States, 31201
    - Central Georgia Cancer Care
  - Macon, Georgia, United States, 31217
    - Georgia Cancer Specialists
  - Marietta, Georgia, United States, 30060
    - Georgia Cancer Specialists
  - Snellville, Georgia, United States, 30078
    - Suburban Hematology Oncology Associates PC
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Oncare Hawaii, Inc-POB2
  - Honolulu, Hawaii, United States, 96817
    - Oncare Hawaii, Inc-KMP
- Idaho
  - Coeur d'Alene, Idaho, United States, 83814
    - Kootenai Cancer Center
  - Meridian, Idaho, United States, 83642
    - Mountain States Tumor Institute
  - Twin Falls, Idaho, United States, 83301
    - Mountain States Tumor Institute
- Illinois
  - Arlington, Illinois, United States, 60005
    - Cancer Care & Hematology Specialists of Chicagoland
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center
  - Chicago, Illinois, United States, 60612
    - MBCCOP, John H. Stroger, JR., Hospital of Cook County-Chicago
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Decatur, Illinois, United States, 62526
    - Cancer Care Specialists-Central Illinois
  - Naperville, Illinois, United States, 60540
    - Edward Hospital
  - Plainfield, Illinois, United States, 60585
    - Edward Cancer Center Plainfield
  - Winfield, Illinois, United States, 60190
    - Cancer Care and Hematology Specialists of Chicagoland
  - Yorkville, Illinois, United States, 60560
    - Yorkville Family Practice
- Indiana
  - Bloomington, Indiana, United States, 47403
    - Cancer Care of Southern Indiana
  - Corydon, Indiana, United States, 47112
    - Corydon Hospital Medical Plaza
  - Elkhart, Indiana, United States, 46514
    - Elkhart Clinic
  - Elkhart, Indiana, United States, 46514
    - Michiana Hematology-Oncology, P.C. (Elkhart)
  - Gary, Indiana, United States, 27518
    - Waverly Hematology Oncology
  - Jeffersonville, Indiana, United States, 47130
    - Clark Medical Building
  - Kokomo, Indiana, United States, 46904
    - Howard Regional Health System
  - LaPorte, Indiana, United States, 46350
    - Michiana Hematology-Oncology, P.C. (LaPorte)
  - New Albany, Indiana, United States, 47150
    - Cancer Care Center
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology-Oncology PC
  - Plymouth, Indiana, United States, 46563
    - Oncology, P.C. Plymouth
  - South Bend, Indiana, United States, 46601
    - Northern Indiana Cancer Research Consortium
  - South Bend, Indiana, United States, 46117
    - South Bend Clinic
  - South Bend, Indiana, United States, 46601
    - Michiana Hematology-Oncology, P.C. (Main Office)
  - South Bend, Indiana, United States, 46617
    - Michiana Hematology-Oncology, P.C. Cedar St.
  - Terre Haute, Indiana, United States, 47802
    - Providence Medical Group
- Iowa
  - Bettendorf, Iowa, United States, 52722
    - Hematology and Medical Oncology Consultants-Bettendorf
  - Davenport, Iowa, United States, 52804
    - Hematology and Medical Oncology Consultants-Davenport
  - Iowa City, Iowa, United States, 52242
    - University of Iowa
- Kansas
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - University of Kentucky Medical Center
  - Louisville, Kentucky, United States, 40207
    - Norton Medical Plaza II
  - Louisville, Kentucky, United States, 40202
    - NortonHealthcare Pavillion
  - Louisville, Kentucky, United States, 40217
    - Norton Medical Plaza West
  - Louisville, Kentucky, United States, 40241
    - Old Brownsboro Crossing
- Louisiana
  - Baton Rouge, Louisiana, United States, 70806
    - Baton Rouge General Medical Center
- Maine
  - Bangor, Maine, United States, 04401
    - Eastern Maine Medical Center
- Maryland
  - Baltimore, Maryland, United States, 21204
    - Greater Baltimore Medical Center
  - Baltimore, Maryland, United States, 21202
    - Mercy Medical Center
  - Baltimore, Maryland, United States, 21237
    - Franklin Square Hospital Center
  - Baltimore, Maryland, United States, 21237
    - Harry & Jeannette Weinberg Cancer Institute
  - Baltimore, Maryland, United States, 21237
    - Hematology-Oncology Associates
  - Bethesda, Maryland, United States, 20817
    - Suburban Hospital
  - Bethesda, Maryland, United States, 20817
    - Carolyn Hendricks, MD
  - Chevy Chase, Maryland, United States, 20815
    - The Office of Frederik Smith
  - Chevy Chase, Maryland, United States, 20815
    - Washington Oncology-Hematology Center, PC-Chevy Chase
  - Rockville, Maryland, United States, 20850
    - Associates in Oncology/Hematology
  - Salisbury, Maryland, United States, 21801
    - Peninsula Regional Medical Center
  - Salisbury, Maryland, United States, 20817
    - Peninsula Regional Oncology & Hematology
  - Silver Spring, Maryland, United States, 20910
    - Holy Cross Hospital
  - Wheaton, Maryland, United States, 20902
    - Oncology Care Associates
- Massachusetts
  - North Adams, Massachusetts, United States, 01247
    - Berkshire Hematology Oncology, P.C.-North Adams
  - Pittsfield, Massachusetts, United States, 01201
    - Berkshire Hematology Oncology, P.C.
- Michigan
  - Adrian, Michigan, United States, 49221
    - Bixby Medical Center
  - Ann Arbor, Michigan, United States, 48106
    - CCOP, St. Joseph Mercy Hospital
  - Battle Creek, Michigan, United States, 49016
    - Battle Creek Health System
  - Bay City, Michigan, United States, 48706
    - Bay Regional Medical Center
  - Bay City, Michigan, United States, 48706
    - Dr. Cook and Abramson - Bay City
  - Brighton, Michigan, United States, 48114
    - St. Joseph Mercy Woodland Health Center
  - Brownstown, Michigan, United States, 48183
    - Josephone Ford Cancer Center
  - Dearborn, Michigan, United States, 48126
    - Henry Ford Medical Center-Fairlane
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Escanaba, Michigan, United States, 49829
    - UP Hematology/Oncology Assoc.-Doctor's Park Family Physicians
  - Flint, Michigan, United States, 48503
    - CCOP Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley
  - Flint, Michigan, United States, 48532
    - Sing and Arora
  - Grand Blanc, Michigan, United States, 48439
    - Genesys Regional Medical Center
  - Grand Rapids, Michigan, United States, 49503
    - Spectrum Health Hospitals
  - Grand Rapids, Michigan, United States, 49503
    - Grand Rapids Clinical Oncology Program
  - Grand Rapids, Michigan, United States, 49503
    - St. Mary's Health Services
  - Grosse Pointe Woods, Michigan, United States, 19229
    - CCOP, St. John Hospital and Medical Center
  - Hancock, Michigan, United States, 49935
    - Portage Internal Medical Associates
  - Iron Mountain, Michigan, United States, 49801
    - UP Hematology/Oncology Associates
  - Ironwood, Michigan, United States, 49938
    - UP Hematology/Oncology Associates-Gogebic Range
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Lambertville, Michigan, United States, 48144
    - Hematology/Oncology Associates of OH and MI, PC
  - Lansing, Michigan, United States, 48910
    - Michigan State University - Breslin Cancer Center
  - Lansing, Michigan, United States, 48909
    - CCOP, Sparrow Health System
  - Lapeer, Michigan, United States, 48446
    - Lapeer Regional Hospital
  - Lapeer, Michigan, United States, 48446
    - Hematology Oncology-Lapeer
  - Laurium, Michigan, United States, 49913
    - Keewanaw Memorial Hospital
  - Livonia, Michigan, United States, 48154
    - St. Mary Mercy Hospital - Livonia
  - Marquette, Michigan, United States, 49855
    - Marquette General Hospital
  - Marquette, Michigan, United States, 49855
    - Upper Peninsula Hematology/Oncology Associates
  - Mount Clemens, Michigan, United States, 48043
    - Mount Clemens Regional Medical Center
  - Mount Clemens, Michigan, United States, 48043
    - Community Cancer Care Specialists-Mt. Clemens
  - Muskegon, Michigan, United States, 49443
    - Hackley Hospital
  - Niles, Michigan, United States, 49120
    - Michiana Hematology-Oncology PC
  - Royal Oak, Michigan, United States, 48073
    - CCOP, William Beaumont Hospital
  - Saginaw, Michigan, United States, 48601
    - CCOP, St. Mary's Medical Center
  - Saint Joseph, Michigan, United States, 49085
    - Lakeside Cancer Specialists, PLLC
  - Saint Joseph, Michigan, United States, 49085
    - Michiana Hematology-Oncology, PC Lakeland
  - Sault Sainte-Marie, Michigan, United States, 49783
    - Chippewa Medical Associates
  - Shelby, Michigan, United States, 48315
    - Osteopathic Medical Oncology Hematology
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - CCOP, St. John Macomb Hospital
  - West Bloomfield, Michigan, United States, 48322
    - Henry Ford Medical Center-West Bloomfield
  - Wyoming, Michigan, United States, 49519
    - Metro Health Hospital
- Minnesota
  - Burnsville, Minnesota, United States, 55337
    - Minnesota Oncology Hematology-Burnsville
  - Burnsville, Minnesota, United States, 55337
    - Park Nicollet Clinic
  - Coon Rapids, Minnesota, United States, 55433
    - Hubert H. Humphrey Cancer Center - Coon Rapids
  - Edina, Minnesota, United States, 55435
    - Minnesota Oncology Hematology-Edina
  - Edina, Minnesota, United States, 55455
    - Fairview Southdale Medical Oncology Clinic
  - Fridley, Minnesota, United States, 55432
    - Hubert H. Humphrey Cancer Center - Fridley
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA - Maplewood
  - Minneapolis, Minnesota, United States, 55407
    - Minnesota Oncology Hematology-Minneapolis
  - Robbinsdale, Minnesota, United States, 55422
    - Hubert H. Humphrey Cancer Center-Robbinsdale
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Health Services
  - Saint Paul, Minnesota, United States, 55102
    - Minnesota Hematology Oncology-St. Paul
  - Waconia, Minnesota, United States, 55387
    - Minnesota Oncology Hematology-Waconia
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology
- Mississippi
  - Southaven, Mississippi, United States, 38671
    - University of Tennessee Cancer Institute
- Missouri
  - Columbia, Missouri, United States, 65203
    - University of Missouri-Ellis Fischel
  - Joplin, Missouri, United States, 64804
    - Freeman Cancer Institute
  - Joplin, Missouri, United States, 64804
    - St. John's Regional Health Center-Joplin
  - Kansas City, Missouri, United States, 64111
    - Saint Luke's Hospital
  - Kansas City, Missouri, United States, 64131
    - CCOP, Kansas City (Administrative Only)
  - Springfield, Missouri, United States, 65807
    - Cox Health Systems
  - Springfield, Missouri, United States, 65805
    - St. John's Regional Health Center
- Montana
  - Billings, Montana, United States, 59101
    - Hematology Oncology Centers of the Northern Rockies
- Nevada
  - Henderson, Nevada, United States, 89052
    - Comprehensive Cancer Centers of Nevada (Siena)
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89135
    - Nevada Cancer Institute
  - Las Vegas, Nevada, United States, 89106
    - Cancer and Blood Specialists- Shadow Lane
  - Las Vegas, Nevada, United States, 89106
    - Cancer Consultants
  - Reno, Nevada, United States, 89502
    - Renown Regional Medical Center
  - Reno, Nevada, United States, 89503
    - Alpine Hematology-Oncology
- New Jersey
  - Berkeley Heights, New Jersey, United States, 07922
    - Summit Medical Group
  - Englewood, New Jersey, United States, 07631
    - Drs. Forte, Schleider, Attas and Condemi, PA
  - Hamilton, New Jersey, United States, 08690
    - Cancer Institute of New Jersey at Hamilton
  - Long Branch, New Jersey, United States, 07740
    - Monmouth Medical Center
  - Morristown, New Jersey, United States, 07960
    - Morristown Memorial Hospital
  - New Brunswick, New Jersey, United States, 08901
    - Cancer Institute of New Jersey
  - Newark, New Jersey, United States, 07112
    - Newark Beth Israel Medical Center
  - Newark, New Jersey, United States, 07103-2425
    - University of Medicine and Dentistry of New Jersey
  - Sparta, New Jersey, United States, 07871
    - Sparta Cancer Treatment Center
  - Summit, New Jersey, United States, 07901
    - Overlook Hospital
- New York
  - Albany, New York, United States, 12206
    - New York Oncology Hematology PC-Albany
  - Albany, New York, United States, 12208
    - NY Oncology Hematology PC at Albany Medical Center
  - Amsterdam, New York, United States, 12010
    - Amsterdam Community Cancer Program
  - Canandaigua, New York, United States, 14424
    - Interlakes Oncology & Hematology, P.C.
  - East Syracuse, New York, United States, 12010
    - Hematology Oncology Assaociates of CNY, CCOP
  - Hudson, New York, United States, 12534
    - NY Oncology Hematology PC-Hudson Carvell Cancer Tx Prog.
  - Latham, New York, United States, 12110
    - NY Oncology Hematology PC- Latham- Capital District Oncology Hematology
  - New York, New York, United States, 10003
    - Beth Israel Medical Center
  - New York, New York, United States, 10019
    - St. Luke's-Roosevelt Hospital Center
  - Rexford, New York, United States, 12148
    - Riverview Cancer Care Medical Association
  - Rome, New York, United States, 13440
    - Hematology Oncology Associates of CNY, CCOP
  - Stony Brook, New York, United States, 11794
    - University Hospital and Medical Center - SUNY
  - Stony Brook, New York, United States, 11794
    - University Hospital and Medical Center-SUNY
  - Syracuse, New York, United States, 13215
    - Hematology Oncology Assoc. of CNY, CCOP (Comm. General Hospital Satellite Office)
  - Troy, New York, United States, 12180
    - Troy Cancer Treatment Program
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Cancer Care of Western North Carolina
  - Asheville, North Carolina, United States, 28801
    - CCOP, Mission Hospitals, Inc.
  - Asheville, North Carolina, United States, 28803
    - Cancer Center of NC at Asheville
  - Charlotte, North Carolina, United States, 28203
    - Carolinas Hematology-Oncology Associates - Tyron St
  - Charlotte, North Carolina, United States, 28204
    - Carolinas Medical Center - Blumenthal Cancer Center
  - Charlotte, North Carolina, United States, 28204
    - CCOP Presbyterian Hospital
  - Charlotte, North Carolina, United States, 28204
    - Mecklenburg Medical Group - Morehead Medical Dr
  - Charlotte, North Carolina, United States, 28211
    - Mecklenburg Medical Group - Cameron Valley Pkwy
  - Charlotte, North Carolina, United States, 28262
    - Carolinas Hematology Oncology Associates - Harris Blvd.
  - Charlotte, North Carolina, United States, 28277
    - Carolinas Hematology-Oncology - John J. Delaney
  - Goldsboro, North Carolina, United States, 27534
    - CCOP, Wayne Memorial Hospital
  - Greensboro, North Carolina, United States, 27403
    - Moses Cone Regional Cancer Center
  - Hickory, North Carolina, United States, 28603
    - Northwestern Carolina Oncology & Hematology, PA
  - Huntersville, North Carolina, United States, 28078
    - Carolina Biooncology Institute
- Ohio
  - Akron, Ohio, United States, 44307
    - Akron General Medical Center
  - Akron, Ohio, United States, 44304
    - Akron City Hospital
  - Alliance, Ohio, United States, 44601
    - Alliance Cancer Center
  - Canton, Ohio, United States, 44710
    - Aultman Hospital
  - Canton, Ohio, United States, 44781
    - Tri County Hematology/Oncology
  - Cincinnati, Ohio, United States, 45236
    - Kenwood Office
  - Cincinnati, Ohio, United States, 45236
    - Oncology/Hematology Care Clinical Trials LLC
  - Cincinnati, Ohio, United States, 45242
    - North Treatment Center - Blue Ash Medical Center
  - Cincinnati, Ohio, United States, 45242
    - Oncology/Hematology Care Clinical Trials LLC, Cincinnati, OH Blue Ash Med. Cntr. (Administrative Only)
  - Cincinnati, Ohio, United States, 45242
    - Oncology/Hematology Care Clinical Trials LLC
  - Cleveland, Ohio, United States, 44106
    - Case Western Reserve/University Hospitals-Ireland Cancer Cntr.
  - Dayton, Ohio, United States, 45415
    - Dayton Physicians-LLC-Hematology & Medical Oncology Division
  - Fairfield, Ohio, United States, 45014
    - Healthplex
  - Greenville, Ohio, United States, 45331
    - Dayton Physicians, LLC - Greenville
  - Hamilton, Ohio, United States, 45013
    - Hamilton Office
  - Kettering, Ohio, United States, 45429
    - Dayton Clinical Oncology Program-Kettering
  - Kettering, Ohio, United States, 45429
    - Marian A. Llenado Lee, MD, Inc.
  - Maumee, Ohio, United States, 43537
    - Northwest Ohio Oncology Center
  - Orange Village, Ohio, United States, 44122
    - UHHS - Chagrin Highlands
  - South Euclid, Ohio, United States, 44121
    - UHHS Green Road-Ireland Cancer Center
  - Sylvania, Ohio, United States, 43560
    - Flower Memorial Hospital
  - Toledo, Ohio, United States, 43616
    - Bayview Oncology Associates
  - Toledo, Ohio, United States, 43617
    - Toledo Clinic
  - Westlake, Ohio, United States, 44145
    - UHHS Westlake-Ireland Cancer Center
- Oregon
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97216
    - Adventist Medical Center
  - Portland, Oregon, United States, 97225
    - Providence St. Vincent Medical Center
  - Portland, Oregon, United States, 97213
    - Northwest Cancer Specialists-Portland
  - Portland, Oregon, United States, 97216
    - Northwest Cancer Specialists-Adventist Office
  - Portland, Oregon, United States, 97225
    - CCOP, Columbia River Oncology
  - Portland, Oregon, United States, 97225
    - Providence Oncology and Hematology Care Clinic
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18105
    - Lehigh Valley Hospital
  - Danville, Pennsylvania, United States, 17882-2170
    - Geisinger Clinic
  - Donora, Pennsylvania, United States, 18142
    - Hematology Oncology Associates of NE PA
  - Ephrata, Pennsylvania, United States, 17522
    - Ephrata Cancer Center at Ephrata Community Hospital
  - Greensburg, Pennsylvania, United States, 15601
    - UPMC Cancer Centers Arnold Palmer Pavilion-Mountainview
  - Greensburg, Pennsylvania, United States, 15601
    - UPMC Cancer Centers Arnold Palmer-Oakbrook
  - Indiana, Pennsylvania, United States, 15701
    - UPMC Cancer Centers-Indiana
  - Johnstown, Pennsylvania, United States, 15901
    - UPMC Cancer Centers-John P. Murtha Cancer Center
  - McKeesport, Pennsylvania, United States, 15132
    - UPMC Cancer Centers - McKeesport Hospital
  - Media, Pennsylvania, United States, 19063
    - Riddle Memorial Hospital
  - Mount Pleasant, Pennsylvania, United States, 15666
    - UPMC Cancer Centers Arnold Palmer-Mt. Pleasant
  - Philadelphia, Pennsylvania, United States, 19141-3098
    - Albert Einstein Healthcare Network
  - Philadelphia, Pennsylvania, United States, 19107
    - Kimmel Cancer Center at Jefferson
  - Philadelphia, Pennsylvania, United States, 19115
    - Cancer Center at Center One
  - Pittsburgh, Pennsylvania, United States, 15213
    - University of Pittsburgh
  - Pittsburgh, Pennsylvania, United States, 15232
    - Hillman Cancer Center
  - Pittsburgh, Pennsylvania, United States, 15212
    - Allegheny General Hospital/Allegheny-Singer Research Institute
  - Pittsburgh, Pennsylvania, United States, 15212
    - NSABP Foundation, Inc
  - Pittsburgh, Pennsylvania, United States, 15215
    - UPMC Cancer Centers - UPMC St. Margaret
  - Pittsburgh, Pennsylvania, United States, 15237
    - UPMC Cancer Centers - UPMC Passavant
  - Scranton, Pennsylvania, United States, 18501
    - Mercy Hospital
  - Scranton, Pennsylvania, United States, 18510
    - Hematology and Oncology Associates
  - Scranton, Pennsylvania, United States, 18501
    - Scranton Hematology Oncology
  - State College, Pennsylvania, United States, 16803
    - Mount Nittany Medical Center
  - Uniontown, Pennsylvania, United States, 15401
    - UPMC Cancer Centers-Uniontown
  - Wexford, Pennsylvania, United States, 15090
    - UPMC Cancer Centers - Wexford
  - York, Pennsylvania, United States, 17403
    - York Hospital
- Tennessee
  - Knoxville, Tennessee, United States, 37916
    - Thompson Cancer Survival Center
  - Knoxville, Tennessee, United States, 37804
    - Thompson Oncology Group-Blount
  - Knoxville, Tennessee, United States, 37909
    - Thompson Cancer Survival Center-Dowell Springs
  - Knoxville, Tennessee, United States, 37932
    - Thompson Oncology Group-West
  - Memphis, Tennessee, United States, 38120
    - The West Clinic
- Texas
  - Dallas, Texas, United States, 75246
    - Texas Oncology- Sammons CC
  - Fort Worth, Texas, United States, 76104
    - The Center for Cancer and Blood Disorders
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine
  - Houston, Texas, United States, 77030
    - Ben Taub General Hospital
  - Lubbock, Texas, United States, 79410
    - Covenant Health System dba Joe Arrington Cancer Research & Treatment Center
  - Plano, Texas, United States, 75075
    - North Texas Regional Cancer Center
- Utah
  - Murray, Utah, United States, 84107
    - Intermountain Medical Center
  - Ogden, Utah, United States, 84403
    - McKay-Dee Hospital
  - Provo, Utah, United States, 84604
    - Utah Valley Regional Medical Center
  - Saint George, Utah, United States, 84780
    - Dixie Medical Center
  - Salt Lake City, Utah, United States, 84143
    - LDS Hospital
- Virginia
  - Richmond, Virginia, United States, 23235
    - VCU Massey Cancer Center at Stony Point
  - Richmond, Virginia, United States, 23298
    - MBCCOP, Virginia Commonwealth University
- Washington
  - Bellevue, Washington, United States, 98004
    - Overlake Internal Medicine
  - Spokane, Washington, United States, 99204
    - Rockwood Cancer Treatment Center
  - Spokane, Washington, United States, 99204
    - Rockwood Cancer Treatment Center - Sinto Ave
  - Vancouver, Washington, United States, 98684
    - Northwest Cancer Specialists-136th Ave
  - Vancouver, Washington, United States, 98686
    - Northwest Cancer Specialists-134th St.
  - Vancouver, Washington, United States, 98664
    - Southwest Washington Hospital
- West Virginia
  - Morgantown, West Virginia, United States, 26506-9162
    - West Virginia University Hospitals Inc.
- Wisconsin
  - Burlington, Wisconsin, United States, 53105
    - Oncology Alliance-Burlington
  - Franklin, Wisconsin, United States, 53132
    - Oncology Alliance-Franklin
  - Glendale, Wisconsin, United States, 53212
    - Oncology Alliance
  - Green Bay, Wisconsin, United States, 54311
    - Aurora BayCare Medical Center
  - Kenosha, Wisconsin, United States, 53143
    - Oncology Alliance-Kenosha South
  - Kenosha, Wisconsin, United States, 53144
    - Oncology Alliance-Kenosha North
  - Marshfield, Wisconsin, United States, 54449
    - CCOP, Marshfield Clinic
  - Menomonee Falls, Wisconsin, United States, 53051
    - Oncology Alliance-Menomonee Falls
  - Mequon, Wisconsin, United States, 53092
    - Oncology Alliance-Mequon
  - Milwaukee, Wisconsin, United States, 53215
    - Oncology Alliance-South
  - Racine, Wisconsin, United States, 53406
    - Oncology Alliance-Racine
  - Waukesha, Wisconsin, United States, 53188
    - Oncology Alliance-Waukeska
  - Weston, Wisconsin, United States, 54476
    - Marshfield Clinic Weston Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Life expectancy of at least 10 years, excluding their diagnosis of breast cancer.
Women who have had breast reconstruction utilizing tissue expanders must be in agreement with delaying surgery to replace the tissue expanders with permanent implants until 3 months following the last dose of bevacizumab
Women of reproductive potential must agree to use an effective non-hormonal method of contraception (for example condoms, some intrauterine devices, diaphragms, vasectomized partner, or abstinence) during therapy and for at least 6 months after the last dose of bevacizumab and/or trastuzumab.
Submission of tumor samples from the breast surgery for central HER2 testing is required for all patients prior to enrollment in the BETH Trial
Signed and dated IRB/EC-approved consent
ECOG performance status of 0 or 1
The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination.
The breast cancer must be HER2-positive based on test results as follows: Local testing (if available) should demonstrate that the tumor is IHC 2+ or 3+ or is considered to be HER2-positive for gene amplification by FISH, CISH, or other in situ hybridization (ISH) method. If local ISH test results are considered equivocal, the tumor can be submitted for central HER2 testing. (If local testing is not possible, the tumor can be submitted for central HER2 testing.) Central testing (a requirement for ALL patients) must demonstrate that the tumor is HER2-positive which is defined as FISH-positive and/or IHC 3+.
All of the following staging criteria (according to the 6th edition of the AJCC Cancer Staging Manual) must be met: By pathologic evaluation, primary tumor must be pT1-3; By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b. If pN0, at least one of the following criteria must be met: Pathologic tumor size > 2.0 cm; ER negative and PgR negative; Histologic and/or nuclear grade 2 (intermediate) or 3 (high); or Age < 35 years
Patients must have undergone either a total mastectomy or breast conserving surgery (lumpectomy).
For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection.)
For patients who undergo mastectomy, margins must be free of gross residual tumor. Patients with microscopic positive margins are eligible.
Patients must have completed one of the following procedures for evaluation of pathologic nodal status: Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; Sentinel lymphadenectomy alone if pathologic nodal staging based on sentinel lymphadenectomy is pN0, pN1mi or pN1b; or Axillary lymphadenectomy without SN isolation procedure.
The interval between the last surgery for breast cancer (treatment or staging) and randomization must be at least 28 days but no more than 84 days.
Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then PgR analysis must also be performed.
The most recent postoperative blood counts, performed within 6 weeks prior to randomization, must meet the following criteria: ANC must be greater than or equal to 1200/mm3; Platelet count must be greater than or equal to 100,000/mm3; and Hemoglobin must be greater than or equal to 10 g/dL.
The following criteria for evidence of adequate hepatic function must be met based on the results of the most recent postoperative tests performed within 6 weeks prior to randomization: total bilirubin must be less than or equal to upper limit of normal (ULN) for the lab unless the patient has a bilirubin elevation > ULN to 1.5 x ULN due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and alkaline phosphatase must be less than or equal to 2.5 x ULN for the lab; and AST must be less than or equal to 1.5 x ULN for the lab. Alkaline phosphatase and AST may not both be > the ULN.
Patients with AST or alkaline phosphatase > ULN are eligible for inclusion in the study if liver imaging (CT, MRI, PET scan, or PET-CT scan performed within 3 months prior to randomization) does not demonstrate metastatic disease and the requirements for evidence of adequate hepatic function are met.
Patients with alkaline phosphatase that is > ULN but less than or equal to 2.5 x ULN are eligible for inclusion in the study if a bone scan,PET scan, or PET-CT scan (performed within 3 months prior to randomization) does not demonstrate metastatic disease.
The following criteria for renal function must be met based on the results of the most recent postoperative tests performed within 6 weeks prior to randomization: Serum creatinine must be less than or equal to ULN for the lab. Measured or calculated creatinine clearance must be > 60 mL/min.
A urine sample must be tested for protein by determination of the urine protein/creatinine (UPC) ratio or by urine dipstick. UPC ratio must be less than 1.0. Urine dipstick must indicate 0-1+ protein. If dipstick reading is greater than or equal to 2+, determine the UPC ratio, which must be less than 1.0, or collect a 24-hour urine specimen, which must demonstrate < 1.0 g of protein per 24 hours.
LVEF assessment must be performed within 3 months prior to randomization. The LVEF must be greater than or equal to 55% regardless of the cardiac imaging facility's lower limit of normal (LLN).
The ECG (performed within 3 months prior to randomization) must not have demonstrated any of the following conditions: ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; and conduction abnormality requiring a pacemaker.

Exclusion Criteria:

Inflammatory breast cancer.
Definitive clinical or radiologic evidence of metastatic disease. (Chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 3 months prior to randomization.)
Synchronous or previous contralateral invasive breast cancer (Patients with synchronous or previous contralateral DCIS or LCIS are eligible).
History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with excision and RT. (Patients with history of ipsilateral LCIS are eligible.)
History of non-breast malignancies within the 5 years prior to study entry, except for the following: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin.
Previous therapy with anthracyclines, taxanes, carboplatin, trastuzumab, or bevacizumab for any malignancy.
RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to randomization.
Continued therapy with any hormonal agent such as raloxifene or tamoxifen (or other SERM) or an aromatase inhibitor. (Patients are eligible if these medications are discontinued prior to randomization.)
Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. Patients are eligible if these medications are discontinued prior to randomization.
Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens. This includes but is not confined to: Active cardiac disease - angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; valvular disease with documented compromise in cardiac function; and symptomatic pericarditis. History of cardiac disease - myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function; history of documented CHF; and documented cardiomyopathy.
Uncontrolled hypertension defined as systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg, with or without anti-hypertensive medication. (BP must be assessed within 28 days prior to randomization.) Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.
History of hypertensive crisis or hypertensive encephalopathy.
History of TIA or CVA.
History of any arterial thrombotic event within 12 months before randomization.
Symptomatic peripheral vascular disease.
Intrinsic lung disease resulting in dyspnea.
Unstable diabetes mellitus.
Active infection or chronic infection requiring chronic suppressive antibiotics.
Any significant bleeding within 6 months before randomization, exclusive of menorrhagia in premenopausal women.
Non-healing wound, skin ulcers, or incompletely healed bone fracture.
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to planned start of study therapy.
Anticipation of need for major surgical procedures during study therapy and for at least 3 months following completion of bevacizumab.
Gastroduodenal ulcer(s) documented by endoscopy to be active within 6 months before randomization.
History of GI perforation, abdominal fistulae, or intra-abdominal abscess.
Known bleeding diathesis or coagulopathy.
Requirement for therapeutic doses of coumadin or equivalent.
Sensory/motor neuropathy greater than or equal to grade 2, as defined by the NCI CTCAE v3.0.
Conditions that would prohibit administration of corticosteroids.
Chronic daily treatment with corticosteroids (dose of > 10 mg/day methylprednisolone equivalent) (excluding inhaled steroids).
History of hypersensitivity reaction to drugs formulated with polysorbate 80.
Pregnancy or lactation at the time of study entry. (Note: Pregnancy testing must be performed within 14 days prior to randomization according to institutional standards for women of child-bearing potential.)
Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Use of any investigational product within 4 weeks prior to enrollment in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: RANDOMIZED
Interventional Model: PARALLEL
Masking: NONE

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1A: TCH-H Docetaxel (T), Carboplatin (C), and Trastuzumab (H) followed by Trastuzumab (H)	Drug: Docetaxel 75 mg/m2 IV on day 1 every 3 weeks for cycles 1-6, Arms 1A and 1B 100 mg/m2 on day 1 every 3 weeks for cycles 1-3, Arms 2A and 2B Other Names: Taxotere Drug: Trastuzumab First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-6. Following completion of chemotherapy cycles: 6 mg/kg IV every 3 weeks until 1 year following first trastuzumab dose. Arms 1A and 1B First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-3. 21 days after last dose of FEC: 8 mg/kg IV first post-FEC dose only; subsequent doses 6 mg/kg IV every 3 weeks for a total of 1 year. Arms 2A and 2B Other Names: Herceptin Drug: Carboplatin 6 mg/ml/min IV on day 1 every 3 weeks for cycles 1-6
EXPERIMENTAL: 1B: TCHB-HB Docetaxel (T), Carboplatin (C), Trastuzumab (H), Bevacizumab (B) followed by Trastuzumab (T) and Bevacizumab (B)	Drug: Docetaxel 75 mg/m2 IV on day 1 every 3 weeks for cycles 1-6, Arms 1A and 1B 100 mg/m2 on day 1 every 3 weeks for cycles 1-3, Arms 2A and 2B Other Names: Taxotere Drug: Trastuzumab First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-6. Following completion of chemotherapy cycles: 6 mg/kg IV every 3 weeks until 1 year following first trastuzumab dose. Arms 1A and 1B First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-3. 21 days after last dose of FEC: 8 mg/kg IV first post-FEC dose only; subsequent doses 6 mg/kg IV every 3 weeks for a total of 1 year. Arms 2A and 2B Other Names: Herceptin Drug: Carboplatin 6 mg/ml/min IV on day 1 every 3 weeks for cycles 1-6 Drug: Bevacizumab 15 mg/kg IV on day 1 every 3 weeks for cycles 1-6. Following completion of chemotherapy cycles: 15 mg/kg IV on day 1 every 3 weeks until 1 year following first bevacizumab dose. Arm 1B 15 mg/kg IV on day 1 every 3 weeks for cycles 1-3. 21 days after the last dose of FEC: 15 mg/kg IV on day 1 every 3 weeks until 1 year following first bevacizumab dose. Arm 2B Other Names: Avastin
ACTIVE_COMPARATOR: 2A: TH-FEC-H Docetaxel (T) and Trastuzumab (H) followed by 5-fluorouracil (F), Epirubicin (E), and Cyclophosphamide (C) followed by Trastuzumab (H)	Drug: Docetaxel 75 mg/m2 IV on day 1 every 3 weeks for cycles 1-6, Arms 1A and 1B 100 mg/m2 on day 1 every 3 weeks for cycles 1-3, Arms 2A and 2B Other Names: Taxotere Drug: Trastuzumab First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-6. Following completion of chemotherapy cycles: 6 mg/kg IV every 3 weeks until 1 year following first trastuzumab dose. Arms 1A and 1B First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-3. 21 days after last dose of FEC: 8 mg/kg IV first post-FEC dose only; subsequent doses 6 mg/kg IV every 3 weeks for a total of 1 year. Arms 2A and 2B Other Names: Herceptin Drug: 5-Fluorouracil 600 mg/m2 IV on day 1 every 3 weeks for cycles 4-6 Drug: Epirubicin 90 mg/m2 IV on day 1 every 3 weeks for cycles 4-6 Drug: Cyclophosphamide 600 mg/m2 IV on day 1 every 3 weeks for cycles 4-6
EXPERIMENTAL: 2B: THB-FEC-HB Docetaxel (T), Trastuzumab (H), and Bevacizumab (B) followed by 5-Fluorouracil (F), Epirubicin (E), and Cyclophosphamide (C) followed by Trastuzumab (H) and Bevacizumab (B)	Drug: Docetaxel 75 mg/m2 IV on day 1 every 3 weeks for cycles 1-6, Arms 1A and 1B 100 mg/m2 on day 1 every 3 weeks for cycles 1-3, Arms 2A and 2B Other Names: Taxotere Drug: Trastuzumab First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-6. Following completion of chemotherapy cycles: 6 mg/kg IV every 3 weeks until 1 year following first trastuzumab dose. Arms 1A and 1B First dose: 8 mg/kg IV on day 1 of cycle 1 only. Subsequent doses: 6 mg/kg IV on day 1 every 3 weeks for cycles 2-3. 21 days after last dose of FEC: 8 mg/kg IV first post-FEC dose only; subsequent doses 6 mg/kg IV every 3 weeks for a total of 1 year. Arms 2A and 2B Other Names: Herceptin Drug: Bevacizumab 15 mg/kg IV on day 1 every 3 weeks for cycles 1-6. Following completion of chemotherapy cycles: 15 mg/kg IV on day 1 every 3 weeks until 1 year following first bevacizumab dose. Arm 1B 15 mg/kg IV on day 1 every 3 weeks for cycles 1-3. 21 days after the last dose of FEC: 15 mg/kg IV on day 1 every 3 weeks until 1 year following first bevacizumab dose. Arm 2B Other Names: Avastin Drug: 5-Fluorouracil 600 mg/m2 IV on day 1 every 3 weeks for cycles 4-6 Drug: Epirubicin 90 mg/m2 IV on day 1 every 3 weeks for cycles 4-6 Drug: Cyclophosphamide 600 mg/m2 IV on day 1 every 3 weeks for cycles 4-6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Invasive Disease-free Survival (IDFS) Time Frame: up to 10 years	up to 10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Invasive disease-free survival (IDFS) within chemotherapy cohorts Time Frame: up to 10 years	up to 10 years
Disease-free survival (DFS) Time Frame: up to 10 years	up to 10 years
Overall survival (OS) Time Frame: Time from randomization until death from any cause or up to a maximum of 10 years from study entry	Time from randomization until death from any cause or up to a maximum of 10 years from study entry
Recurrence-free interval (RFI) Time Frame: Time from randomization until local, regional or distant recurrence or up to a maximum of 10 years from study entry	Time from randomization until local, regional or distant recurrence or up to a maximum of 10 years from study entry
Distant recurrence-free interval (DRFI) Time Frame: Time from randomization until distant disease recurrence only or up to a maximum of 10 years from study entry	Time from randomization until distant disease recurrence only or up to a maximum of 10 years from study entry
Cardiac toxicity. Cumulative incidence of severe cardiac events defined as definite or probable cardiac death, or NYHA Class III or IV CHF Time Frame: 2-3 weeks after cycle 3; 2-3 weeks after last chemotherapy dose; 7, 10, 18, 36, and 60 months from randomization	2-3 weeks after cycle 3; 2-3 weeks after last chemotherapy dose; 7, 10, 18, 36, and 60 months from randomization
Non-cardiac toxicity. Frequencies of adverse events categorized using the NCI CTCAE v3.0. Time Frame: within 3 days of each chemotherapy cycle; 2-3 weeks following last chemotherapy dose; every 6 weeks during targeted therapy; every 6 months through year 5; every 12 months years 6 - 10	within 3 days of each chemotherapy cycle; 2-3 weeks following last chemotherapy dose; every 6 weeks during targeted therapy; every 6 months through year 5; every 12 months years 6 - 10
Identification of biomarkers (from tumor and serum/plasma) predictive for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment for HER2-positive breast cancer as well as for cardiac toxicity Time Frame: baseline, during therapy and follow-up, within 2 weeks of LVEF assessments, any protocol-specified cardiac event, and after diagnosis of recurrence	baseline, during therapy and follow-up, within 2 weeks of LVEF assessments, any protocol-specified cardiac event, and after diagnosis of recurrence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NSABP Foundation Inc

Collaborators

Hoffmann-La Roche

Genentech, Inc.

Cancer International Research Group (CIRG)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

February 21, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (ESTIMATE)

February 29, 2008

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NSABP B-44-I
CIRG (TRIO) 011 (OTHER: Cancer International Research Group)
Roche BO20906 (OTHER: Roche)
BETH (OTHER: NSABP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Northwestern University
Eisai Inc.

Unknown

Carboplatin and Eribulin Mesylate in Triple Negative Breast Cancer Patients

Male Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...

United States
Rutgers, The State University of New Jersey
National Cancer Institute (NCI); Rutgers Cancer Institute of New Jersey

Active, not recruiting

Pegylated Liposomal Doxorubicin Hydrochloride and Carboplatin Followed by Surgery and Paclitaxel in Treating Patients With Triple Negative Stage II-III Breast Cancer

Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast Cancer

United States
University of Southern California
National Cancer Institute (NCI)

Terminated

Endoscopic Breast Surgery in Treating Patients With Breast Cancer

Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer

United States
University of Washington

Terminated

Occupational Therapist-Led Work Intervention in Facilitating Work Maintenance or Re-entry to the Workforce in Patients With Stage I to III Breast Cancer Undergoing Chemotherapy

Breast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIc

United States
Celgene

Completed

Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) (tnAcity)

Breast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...

United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
University of Southern California
National Cancer Institute (NCI)

Terminated

PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer

HER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer

United States
University of Washington
National Cancer Institute (NCI)

Completed

Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery

HER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...

United States
University of Southern California
National Cancer Institute (NCI)

Withdrawn

Azacitidine in Treating Patients With Triple Negative Stage I-IV Invasive Breast Cancer That Can Be Removed By Surgery

Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
Baylor Breast Care Center

Recruiting

Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer (RESPONSE)

Breast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer Invasive

United States
Innocrin Pharmaceutical

Completed

CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448) (CLARITY-01)

Breast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the Breast

United States

Clinical Trials on Docetaxel

Nereus Pharmaceuticals, Inc.

Completed

Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer

Cancer

United States, Australia, India, Chile, Brazil, Argentina
Tianjin Medical University Cancer Institute and...

Recruiting

Phase II Clinical Trial to Evaluate the Safety and Efficacy of TQB2450 Injection Combined With Anlotinib Capsule and Chemotherapy in the Treatment of Immunoresistant Advanced Non-small Cell Lung Cancer

Non-small-cell Lung Cancer

China
Zhuhai Beihai Biotech Co., Ltd

Completed

A Bioequivalence Study of Docetaxel Injection in Patients With Solid Tumours

Solid Tumours | Bioequivalence | Docetaxel

India
Jiangsu HengRui Medicine Co., Ltd.
Shanghai Pulmonary Hospital, Shanghai, China

Completed

A Study of Famitinib Plus Docetaxel in Patients With Advanced Non-squamous and Non-Small Cell Lung Cancer (NSCLC)

Non-Small Cell Lung Cancer (NSCLC)

China
National Cancer Center, Korea
Seoul National University Bundang Hospital; Gachon University Gil Medical Center and other collaborators

Unknown

Docetaxel Versus Docetaxel Plus Cisplatin Versus Docetaxel Plus S-1 as Second-line Chemotherapy in Metastatic Gastric Cancer

Gastric Cancer

Korea, Republic of
Optimal Health Research

Completed

A Novel Approach for Alleviating the Side Effects of Chemotherapeutic Agents.

Breast Cancer | Lung Cancer | Prostate Cancer

United States
Arog Pharmaceuticals, Inc.

Withdrawn

A Phase 2 Study in Patients With Advanced Non-Small Cell Lung Cancer Using New Agents With and Without Docetaxel.

Carcinoma, Non-Small-Cell Lung
Boehringer Ingelheim

Completed

BIBF 1120 + Docetaxel (Japan) in Patients With Advanced Non-small-cell Lung Cancer, Phase I

Carcinoma, Non-Small-Cell Lung

Japan
Sanofi

Completed

Study of Combination Docetaxel and Radiotherapy With or Without Cisplatin to Treat Local Advanced Head and Neck Cancer (TAX200006)

Head and Neck Neoplasms

France
Sanofi

Completed

Pulmonart: Docetaxel - Non-Small Cell Lung Cancer (NSCLC)

Lung Neoplasms

France, Netherlands, Spain, Turkey, Belgium, Finland, Italy, United Kingdom

BETH Study: Treatment of HER2 Positive Breast Cancer With Chemotherapy Plus Trastuzumab vs Chemotherapy Plus Trastuzumab Plus Bevacizumab (BETH)

A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients With HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab With Chemotherapy Plus Trastuzumab Plus Bevacizumab

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Study record dates

Study Major Dates

Study Start

Primary Completion (ACTUAL)

Study Completion (ACTUAL)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (ESTIMATE)

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Breast Cancer

Clinical Trials on Docetaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations