Trial information

BETH Study: A Study of Avastin (Bevacizumab) in Combination With Chemotherapy + Herceptin (Trastuzumab) in Patients With HER2-Positive Early Breast Cancer.

Status: Recruiting

Protocol number: BO20906

Sponsor: Hoffmann-La Roche; NSABP

Company division: Pharmaceutical

Official Scientific Title: BETH: A randomized, open-label study of adjuvant therapy for patients with HER2-positive node-positive or high risk node-negative breast cancer, comparing the effect on disease-free survival of chemotherapy plus Herceptin, with chemotherapy plus Herceptin plus Avastin

Brief summary: This study will assess the efficacy and safety of adding Avastin to regimens of chemotherapy plus Herceptin in patients with resected node-positive or high risk node-negative, HER2-positive breast cancer. Patients will be randomized to receive standard chemotherapy + Herceptin (8mg/kg iv on day 1 of cycle 1 followed by 6mg/kg iv every 3 weeks) or standard chemotherapy + Herceptin + Avastin (15mg/kg iv every 3 weeks). The anticipated time on study treatment is 1 year, and the target sample size is 500+ individuals.In the US this trial is sponsored/managed by NSABP. Target sample size is 3600.

Study phase: III

Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study

Condition: Breast Cancer

Intervention type: Drug

Intervention name: bevacizumab [Avastin]

Primary outcome: 1. Invasive disease-free survival Time frame: Event driven

Key secondary outcomes: 1. Overall survival, recurrence-free interval, distant recurrence-free interval. Time frame: Event driven 2. Cardiac and non-cardiac toxicity Time frame: Throughout study

Inclusion criteria:

• female patients, >=18 years of age;
• HER2-positive breast cancer;
• total mastectomy, or breast conserving surgery;
• ECOG performance status of 0 or 1.

Exclusion criteria:

• clinical or radiologic evidence of metastatic disease;
• previous treatment for the currently diagnosed breast cancer;
• previous treatment with anthracyclines, taxanes, carboplatin, Herceptin or Avastin for any malignancy;
• clinically significant cardiovascular disease.

Gender: Females

Age limits: Min: 18 Years Max: N/A (No limit)

Accepts healthy volunteers: No

Anticipated start date: September, 2008

Trial registration date: 04/18/2008

Date last updated: 11/21/2008

Link to trial result

This trial is being conducted at the following locations:

Argentina

• Buenos Aires
• La Plata
• Pilar
• Santa Fe

Australia

• Adelaide
• Brisbane
• Campbelltown
• Frankston
• Gosford
• Heidelberg
• Liverpool
• Malvern
• Melbourne
• Milton
• Perth
• St. Leonards
• Sydney
• Wollongong

Austria

• Graz
• Innsbruck
• Klagenfurt
• Kufstein
• Leoben
• Linz
• Oberwart
• Salzburg
• Vöcklabruck
• Wels
• Wien

Belgium

• Brasschaat
• Charleroi
• Ottignies
• Wilrijk

Bosnia and Herzegovina

• Sarajevo

Brazil

• Belo Horizonte
• Campinas
• Fortaleza
• Goiania
• Ijuí
• Jaú
• Porto Alegre
• Porto Alegre Rs
• Rio De Janeiro
• Santo Andre
• Sao Paulo
• Sorocaba

Bulgaria

• Plovdiv
• Sofia

Canada

• Calgary, AB
• Edmonton, AB
• Mediciine Hat, AB
• North Vancouver, BC
• St John'S
• Brampton, ON
• Newmarket, ON
• Ottawa, ON
• Sudbury, ON
• Toronto, ON
• Windsor, ON
• Greenfield Park, QC
• Montreal, QC
• Quebec City, QC

Chile

• Santiago

China

• Beijing
• Hang Zhou
• Hong Kong
• Nanjing
• Suzhou
• Wuhan
• Zhejiang

Colombia

• Bogota
• Medellin

Croatia

• Osijek
• Split
• Zagreb

Czech Republic

• Brno
• Praha

Ecuador

• Guayaquil
• Quito

Egypt

• Cairo
• Giza

Estonia

• Tallinn

France

• Amiens
• Beauvais
• Besancon
• Bordeaux
• Brest
• Colmar
• Creteil
• Dechy
• Evreux
• Grenoble
• La Roche Sur Yon
• Limoges
• Marseille
• Montpellier
• Nantes
• Neuilly-Sur-Seine
• Paris
• Poitiers
• Rouen
• Strasbourg
• Toulon
• Toulouse
• Tours

Germany

• Amberg
• Bad Nauheim
• Böblingen
• Bonn
• Chemnitz
• Dortmund
• Dresden
• Düsseldorf
• Eggenfelden
• Erlangen
• Essen
• Frankfurt Am Main
• Freiburg
• Fulda
• Georgsmarienhütte
• Göttingen
• Hamburg
• Hameln
• Hanau
• Hannover
• Herne
• Jena
• Kaiserslautern
• Kiel
• Köln
• Leer
• Lemgo
• Lich
• Mainz
• Marburg
• Minden
• München
• Münchengladbach
• Münster
• Recklinghausen
• Rosenheim
• Saarbrücken
• Stadthagen
• Stendal
• Stuttgart
• Traunstein
• Tübingen
• Wiesbaden

Greece

• Athens
• Heraklion
• Thessaloniki

Hungary

• Budapest
• Debrecen
• Gyor
• Gyula
• Kaposvar
• Szeged

Ireland

• Cork
• Donegal
• Dublin
• Galway
• Limerick

Israel

• Haifa
• Kfar Saba
• Petah Tikva
• Ramat Gan
• Rehovot
• Tel Aviv
• Zefat
• Zerifin

Italy

• Bologna
• Catania
• Chieti
• Firenze
• Lecce
• Legnago
• Napoli
• Noale
• Palermo
• Pavia
• Roma
• San Giovanni Rotondo
• Sassari
• Sora
• Taormina

Latvia

• Riga

Lebanon

• Beirut
• Jbeil

Mexico

• Durango
• Leon
• Mexico City
• Monterrey

Peru

• Arequipa
• Lima

Philippines

• Cebu City
• Manila
• Quezon City

Poland

• Bialystok
• Gliwice
• Krakow
• Olsztyn
• Rybnik
• Warszawa

Portugal

• Coimbra
• Porto

Romania

• Alba Iulia
• Bucharest
• Cluj-Napoca

Russian Federation

• Kazan
• Moscow
• St Petersburg

Slovakia

• Banska Bystrica
• Bratislava

Slovenia

• Maribor

South Africa

• Bloemfontein
• Durban
• Johannesburg

Spain

• Alcorcon
• Alicante
• Badalona
• Barcelona
• Caceres
• Elche
• Gijon
• Girona
• Guadalajara
• Huesca
• Jaen
• La Coruna
• La Laguna
• Las Palmas de Gran Canaria
• Lugo
• Madrid
• Malaga
• Manresa
• Murcia
• Orense
• Pontevedra
• Sabadell
• Salamanca
• San Sebastian
• Santa Cruz de Tenerife
• Sevilla
• Terrassa
• Toledo
• Torrevieja
• Valencia
• Zaragoza

Sweden

• Goeteborg
• Stockholm

Taiwan

• Changhua
• Kaohsiung
• Tainan
• Taipei
• Taoyuan

Thailand

• Bangkok
• Songkhla

Tunisia

• Sfax
• Tunis

Turkey

• Ankara
• Istanbul

United Kingdom

• Bournemouth
• Bristol
• Chelsmford
• Ipswich
• Norwich
• Nottingham
• Peterborough
• Southampton
• Truro

United States

• Birmingham, AL
• Decatur, AL
• Huntsville, AL
• Little Rock, AR
• Alhambra, CA
• Anaheim, CA
• Bakersfield, CA
• Baldwin Park, CA
• Bellflower, CA
• Burbank, CA
• Chula Vista, CA
• Corona, CA
• Fontana, CA
• Fountain Valley, CA
• Fullerton, CA
• Glendora, CA
• Greenbrae, CA
• Hawthorne, CA
• Hayward, CA
• Huntington Beach, CA
• Irvine, CA
• La Jolla, CA
• La Mesa, CA
• Lancaster, CA
• Long Beach, CA
• Los Alamitos, CA
• Los Angeles, CA
• Mission Hills, CA
• Northridge, CA
• Oakland, CA
• Oceanside, CA
• Orange, CA
• Oxnard, CA
• Panorama City, CA
• Pasadena, CA
• Pomona, CA
• Rancho Cucamonga, CA
• Rancho Mirage, CA
• Redondo Beach, CA
• Riverside, CA
• Roseville, CA
• Sacramento, CA
• San Diego , CA
• San Francisco, CA
• San Jose, CA
• Santa Barbara, CA
• Santa Clara, CA
• Santa Maria, CA
• Santa Monica, CA
• Solvang, CA
• South San Francisco , CA
• Stanford, CA
• Sylmar, CA
• Valencia, CA
• Vallejo, CA
• Vista, CA
• Walnut Creek, CA
• West Covina, CA
• Woodland Hills, CA
• Aurora, CO
• Colorado Springs, CO
• Denver, CO
• Englewood, CO
• Grand Junction, CO
• Lafayette, CO
• Lakewood, CO
• Lone Tree, CO
• Longmont, CO
• Loveland, CO
• Pueblo, CO
• Thornton, CO
• Wheat Ridge, CO
• Bridgeport, CT
• Fairfield, CT
• Hartford, CT
• Meriden, CT
• Norwich, CT
• Trumbull, CT
• Waterbury, CT
• Newark, DE
• Washington, DC
• Aventura, FL
• Boca Raton, FL
• Bonita Springs, FL
• Boynton Beach, FL
• Bradenton, FL
• Cape Coral, FL
• Coral Springs, FL
• Davie, FL
• Englewood, FL
• Fort Myers, FL
• Gainesville, FL
• Jacksonville, FL
• Jacksonville Beach, FL
• Jupiter, FL
• Lake Worth, FL
• Lakeland, FL
• Miami, FL
• Naples, FL
• Orange Park, FL
• Orlando, FL
• Palatka, FL
• Palm Beach Gardens, FL
• Port Charlotte, FL
• Sarasota , FL
• St. Augustine, FL
• Venice, FL
• Wellington, FL
• West Palm Beach, FL
• Winter Park, FL
• Albany, GA
• Athens, GA
• Atlanta, GA
• Augusta, GA
• Austell, GA
• Carrolton, GA
• Cartersville, GA
• Decatur, GA
• Douglasville, GA
• Duluth, GA
• Lawrenceville, GA
• Macon , GA
• Marietta, GA
• Savannah, GA
• Snellville, GA
• Tucker, GA
• Valdosta, GA
• Honolulu, HI
• Boise, ID
• Coeur D'Alene, ID
• Fruitland, ID
• Meridian, ID
• Nampa, ID
• Twin Falls, ID
• Chicago, IL
• Decatur, IL
• Elgin, IL
• Naperville, IL
• Park Ridge, IL
• Plainfield, IL
• Yorkville, IL
• Bedford, IN
• Bloomington, IN
• New Albany, IN
• Terre Haute, IN
• Bettendorf, IA
• Davenport, IA
• Iowa City, IA
• Lawrence, KS
• Crestview Hills, KY
• Lexington, KY
• Louisville, KY
• Baton Rouge, LA
• Metairie, LA
• New Orleans, LA
• Bangor, ME
• Baltimore, MD
• Bethesda, MD
• Chevy Chase, MD
• Kensignton, MD
• Rockville, MD
• Salisbury, MD
• Silver Spring, MD
• Washington, MD
• Wheaton, MD
• Boston, MA
• Fall River, MA
• Pittsfield, MA
• Plymouth, MA
• Adrian, MI
• Ann Arbor, MI
• Battle Creek, MI
• Bay City, MI
• Big Rapids, MI
• Detroit, MI
• East Lansing, MI
• Escanaba, MI
• Flint, MI
• Grand Rapids, MI
• Grosse Pointe Woods, MI
• Hancock, MI
• Iron Mountain, MI
• Ironwood, MI
• Jackson, MI
• Kalamazoo, MI
• Lambertsville, MI
• Lapeer, MI
• Laurium, MI
• Livonia, MI
• Marquette, MI
• Mt Clemens, MI
• Muskegon, MI
• Royal Oaks, MI
• Saginaw, MI
• Sault St. Marie, MI
• Traverse City, MI
• Wyoming, MI
• Burnsville, MN
• Coon Rapids, MN
• Edina, MN
• Fridley, MN
• Maplewood, MN
• Minneapolis, MN
• Robbinsdale, MN
• St Louis Park, MN
• St. Paul, MN
• Woodbury, MN
• Jackson, MS
• South Haven, MS
• Columbia , MO
• Joplin, MO
• Kansas City, MO
• Springfield, MO
• St Louis, MO
• St. Louis, MO
• Billings, MT
• Great Falls, MT
• Carson City, NV
• Henderson , NV
• Las Vegas, NV
• Reno , NV
• Englewood, NJ
• Hamilton, NJ
• Livingston, NJ
• Long Branch, NJ
• Morristown, NJ
• New Brunswick, NJ
• Newark, NJ
• Summit, NJ
• Albany, NY
• Amsterdam, NY
• Brockport, NY
• Canandaigua, NY
• East Syracuse, NY
• Geneva, NY
• Glenn Falls, NY
• Hudson, NY
• Lake Success, NY
• Latham, NY
• New York, NY
• Rochester, NY
• Rome, NY
• Staten Island, NY
• Syracuse, NY
• Troy, NY
• Greeley
• Asheville, NC
• Burlington, NC
• Cary , NC
• Charlotte, NC
• Goldsboro, NC
• Greensboro, NC
• Hendersonville, NC
• Hickory , NC
• Huntersville, NC
• Matthews, NC
• Winston-Salem, NC
• Akron, OH
• Canton, OH
• Cincinnati, OH
• Cleveland, OH
• Dayton, OH
• Fairfield, OH
• Hamilton, OH
• Kettering , OH
• Maumee, OH
• Middletown, OH
• Oregon, OH
• Sylvania, OH
• Toledo, OH
• Troy, OH
• Wilmington, OH
• Xenia, OH
• Tulsa , OK
• Beaverton, OR
• Portland, OR
• Allentown, PA
• Bryn Mawr, PA
• Danville, PA
• Hershey, PA
• Lancaster, PA
• Paoli, PA
• Philadelphia, PA
• Pittsburgh, PA
• Scranton, PA
• State College, PA
• Wynnewood, PA
• York, PA
• Johnson City, TN
• Kingsport, TN
• Knoxville, TN
• Maryville, TN
• Memphis , TN
• Burleson, TX
• Corpus Christi, TX
• Dallas, TX
• Denton, TX
• Fort Worth, TX
• Houston, TX
• Lubbock, TX
• Mineral Wells, TX
• San Antonio, TX
• Weatherford, TX
• St. George, UT
• Chesapeake, VA
• Richmond, VA
• Aberdeen, WA
• Centralia, WA
• Olympia, WA
• Vancouver , WA
• Morgantown, WV
• Burlington, WI
• Eau Claire, WI
• Franklin, WI
• Glendale, WI
• Green Bay, WI
• Kenosha, WI
• Marshfield, WI
• Menomonee Falls, WI
• Mequon, WI
• Milwaukee, WI
• Minocqua, WI
• Racine, WI
• Waukeska, WI
• Wauwatosa, WI
• Weston, WI

Uruguay

• Montevideo

Venezuela

• Barquisimeto
• Caracas