A Study of Avastin (Bevacizumab) Plus Taxane-Based Therapy in Patients With Locally Recurrent or Metastatic Breast Cancer.

NCT ID: NCT00448591

Last Updated: 2015-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2296 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2013-02-28

Brief Summary

This single arm study will assess the safety and efficacy of a regimen of Avastin plus a taxane, with or without additional chemotherapy, as first-line treatment in patients with locally recurrent or metastatic breast cancer. All patients will receive Avastin (10mg/kg iv every 2 weeks, or 15 mg/kg iv every 3 weeks) plus taxane-based chemotherapy. If taxanes are contraindicated, alternative chemotherapy (other than anthracyclines or pegylated liposomal doxorubicin) may be used. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

bevacizumab [Avastin]

Intervention Type: DRUG

10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle

Taxane-based chemotherapy

Intervention Type: DRUG

As prescribed

Interventions

bevacizumab [Avastin]

10mg/kg iv on day 1 of each 3 week cycle, or 15mg/kg iv on day 1 of each 2 week cycle

Intervention Type: DRUG

Taxane-based chemotherapy

As prescribed

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• patients, >=18 years of age;
• HER-2 negative adenocarcinoma of the breast, with locally recurrent or metastatic disease; (HER-2 positive patients only if previously treated with Herceptin in the adjuvant setting;
• candidates for chemotherapy.

Exclusion Criteria

• previous chemotherapy for metastatic or locally recurrent breast cancer;
• concomitant hormonal therapy for metastatic or locally recurrent disease;
• concomitant Herceptin therapy for treatment of metastatic or locally recurrent HER-2 positive disease;
• previous radiotherapy for treatment of metastatic disease;
• evidence of CNS metastases.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Gaziantep, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Shhiye, Ankara, , Turkey (Türkiye)

Glasgow, , United Kingdom

London, , United Kingdom

Peterborough, , United Kingdom

Sutton, , United Kingdom

Truro, , United Kingdom

Westcliffe-on-sea, , United Kingdom

Worthing, , United Kingdom

Colchester, , United Kingdom

Coventry, , United Kingdom

Buenos Aires, , Argentina

Buenos Aires, , Argentina

La Plata, , Argentina

Rosario, , Argentina

San Miguel de Tucumán, , Argentina

Adelaide, , Australia

Darlinghurst, , Australia

East Melbourne, , Australia

Frankston, , Australia

Gosford, , Australia

Lismore, , Australia

Maroochydore, , Australia

Milton, , Australia

Perth, , Australia

Richmond, , Australia

St Leonards, , Australia

Sydney, , Australia

Sydney, , Australia

Wodonga, , Australia

Bludesch, , Austria

Bregenz, , Austria

Dornbirn, , Austria

Graz, , Austria

Hall in Tirol, , Austria

Innsbruck, , Austria

Klagenfurt, , Austria

Krems, , Austria

Kufstein, , Austria

Leoben, , Austria

Linz, , Austria

Ried-innkreis, , Austria

Sankt Pölten, , Austria

Sankt Veit an der Glan, , Austria

Steyr, , Austria

Vienna, , Austria

Vienna, , Austria

Vienna, , Austria

Vienna, , Austria

Vienna, , Austria

Villach, , Austria

Wels, , Austria

Wiener Neustadt, , Austria

Zams, , Austria

Belo Horizonte, , Brazil

Belo Horizonte, , Brazil

Belo Horizonte, , Brazil

Campinas, , Brazil

Campinas, , Brazil

Curitiba, , Brazil

Curitiba, , Brazil

Fortaleza, , Brazil

Fortaleza, , Brazil

Goiânia, , Brazil

Ijuí, , Brazil

Jaú, , Brazil

João Pessoa, , Brazil

Niterói, , Brazil

Piracicaba, , Brazil

Porto Alegre, , Brazil

Porto Alegre, , Brazil

Porto Alegre, , Brazil

Porto Alegre, , Brazil

Porto Alegre, , Brazil

Recife, , Brazil

Ribeirão Preto, , Brazil

Rio de Janeiro, , Brazil

Rio de Janeiro, , Brazil

Rio de Janeiro, , Brazil

Salvador, , Brazil

Santos, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

São Paulo, , Brazil

Sorocaba, , Brazil

Vitória, , Brazil

Plovdiv, , Bulgaria

Sofia, , Bulgaria

Sofia, , Bulgaria

Varna, , Bulgaria

Veliko Tarnovo, , Bulgaria

Surrey, British Columbia, Canada

Barrie, Ontario, Canada

Brampton, Ontario, Canada

East York, Ontario, Canada

Mississauga, Ontario, Canada

Newmarket, Ontario, Canada

Sault Ste. Marie, Ontario, Canada

Scarborough Village, Ontario, Canada

St. Catharines, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Toronto, Ontario, Canada

Windsor, Ontario, Canada

Montreal, Quebec, Canada

Québec, Quebec, Canada

Regina, Saskatchewan, Canada

Beijing, , China

Beijing, , China

Changchun, , China

Changsha, , China

Chengdu, , China

Chongqing, , China

Guangzhou, , China

Hangzhou, , China

Hefei, , China

Nanjing, , China

Shanghai, , China

Shanghai, , China

Suzhou, , China

Tianjin, , China

Cali, , Colombia

Neiva, , Colombia

Pereira, , Colombia

Brno, , Czechia

Hradec Králové, , Czechia

Ostrava, , Czechia

Prague, , Czechia

Quito, , Ecuador

Alexandria, , Egypt

Tallinn, , Estonia

Tartu, , Estonia

Hämeenlinna, , Finland

Kotka, , Finland

Kuopio, , Finland

Pori, , Finland

Tampere, , Finland

Turku, , Finland

Vaasa, , Finland

Alès, , France

Angers, , France

Avignon, , France

Bayonne, , France

Bayonne, , France

Besançon, , France

Bobigny, , France

Bordeaux, , France

Bordeaux, , France

Boulogne-Billancourt, , France

Boulogne-sur-Mer, , France

Brest, , France

Chalon-sur-Saône, , France

Châteauroux, , France

Clermont-Ferrand, , France

Colmar, , France

Créteil, , France

Dax, , France

Dijon, , France

Gap, , France

Grenoble, , France

La Chaussée-Saint-Victor, , France

La Tronche, , France

Le Chesnay, , France

Le Coudray, , France

Le Mans, , France

Lille, , France

LIsle-dEspagnac, , France

Lyon, , France

Mantes-la-Jolie, , France

Marseille, , France

Marseille, , France

Metz, , France

Metz, , France

Mont-de-Marsan, , France

Montbéliard, , France

Montfermeil, , France

Montpellier, , France

Mougins, , France

Nancy, , France

Nevers, , France

Niort, , France

Nîmes, , France

Paris, , France

Paris, , France

Paris, , France

Paris, , France

Paris, , France

Paris, , France

Perpignan, , France

Périgueux, , France

Pierre-Bénite, , France

Pontoise, , France

Reims, , France

Rouen, , France

Saint-Brieuc, , France

Saint-Cloud, , France

Saint-denis de La Reunion, , France

Saint-Grégoire, , France

Saint-Jean, , France

Saint-Pierre, , France

Saint-Priest-en-Jarez, , France

Strasbourg, , France

Strasbourg, , France

Toulon, , France

Toulouse, , France

Toulouse, , France

Tours, , France

Valenciennes, , France

Vandœuvre-lès-Nancy, , France

Vannes, , France

Villeneuve-sur-Lot, , France

Augsburg, , Germany

Bad Saarow, , Germany

Berlin, , Germany

Berlin, , Germany

Berlin, , Germany

Bielefeld, , Germany

Bochum, , Germany

Böblingen, , Germany

Chemnitz, , Germany

Cottbus, , Germany

Deggendorf, , Germany

Dresden, , Germany

Duisburg, , Germany

Düsseldorf, , Germany

Erfurt, , Germany

Essen, , Germany

Frankfurt, , Germany

Freiburg im Breisgau, , Germany

Halle, , Germany

Hamburg, , Germany

Hamburg, , Germany

Hanover, , Germany

Hanover, , Germany

Kassel, , Germany

Kiel, , Germany

Leipzig, , Germany

Lübeck, , Germany

Magdeburg, , Germany

Magdeburg, , Germany

Mainz, , Germany

Mannheim, , Germany

München, , Germany

Regensburg, , Germany

Rostock, , Germany

Saarbrücken, , Germany

Stralsund, , Germany

Stuttgart, , Germany

Stuttgart, , Germany

Troisdorf, , Germany

Ulm, , Germany

Unna, , Germany

Wiesbaden, , Germany

Wuppertal, , Germany

Würselen, , Germany

Hong Kong, , Hong Kong

Hong Kong, , Hong Kong

Budapest, , Hungary

Budapest, , Hungary

Szeged, , Hungary

Beersheba, , Israel

Haifa, , Israel

Holon, , Israel

Jerusalem, , Israel

Jerusalem, , Israel

Kfar Saba, , Israel

Dundee, , United Kingdom

Nahariya, , Israel

Petah Tikva, , Israel

Ramat Gan, , Israel

Rehovot, , Israel

Safed, , Israel

Tel Aviv, , Israel

Ẕerifin, , Israel

Ancona, , Italy

Aviano, , Italy

Brescia, , Italy

Cagliari, , Italy

Cagliari, , Italy

Candiolo, , Italy

Carpi, , Italy

Castelfranco Veneto, , Italy

Castrovillari, , Italy

Catania, , Italy

Chieti, , Italy

Como, , Italy

Cremona, , Italy

Frattamaggiore, , Italy

Genova, , Italy

Lecce, , Italy

Lido di Camaiore, , Italy

Lucca, , Italy

Mantova, , Italy

Messina, , Italy

Milan, , Italy

Milan, , Italy

Montevarchi, , Italy

Napoli, , Italy

Novara, , Italy

Palermo, , Italy

Paola, , Italy

Pavia, , Italy

Piove di Sacco, , Italy

Pordenone, , Italy

Pozzuoli, , Italy

Prato, , Italy

Ravenna, , Italy

Rionero in Vulture, , Italy

Roma, , Italy

Roma, , Italy

Roma, , Italy

Roma, , Italy

Roma, , Italy

Salerno, , Italy

San Giovanni Rotondo, , Italy

Saronno, , Italy

Sassari, , Italy

Siena, , Italy

Torino, , Italy

Verona, , Italy

Vicenza, , Italy

Riga, , Latvia

Riga, , Latvia

Beirut, , Lebanon

Beirut, , Lebanon

Kaunas, , Lithuania

Klaipėda, , Lithuania

Vilnius, , Lithuania

Chihuahua City, , Mexico

Ciudad Juárez, , Mexico

Guadalajara, , Mexico

León, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Mexico City, , Mexico

Puebla City, , Mexico

Tijuana, , Mexico

Rabat, , Morocco

Rabat, , Morocco

Ac Amsterdam, , Netherlands

Blaricum, , Netherlands

Capelle Ad Yssel, , Netherlands

Delftzijl, , Netherlands

Doetinchem, , Netherlands

Flushing, , Netherlands

Goes, , Netherlands

Hoofddorp, , Netherlands

Zoetermeer, , Netherlands

Bydgoszcz, , Poland

Lublin, , Poland

Olsztyn, , Poland

Poznan, , Poland

Warsaw, , Poland

Warsaw, , Poland

Almada, , Portugal

Aveiro, , Portugal

Barreiro, , Portugal

Beja, , Portugal

Cascais, , Portugal

Coimbra, , Portugal

Lisbon, , Portugal

Lisbon, , Portugal

Lisbon, , Portugal

Porto, , Portugal

Porto, , Portugal

Porto, , Portugal

Santa Maria da Feira, , Portugal

Santarém, , Portugal

Setúbal, , Portugal

Vila Nova de Gaia, , Portugal

Balashikha, , Russia

Barnaul, , Russia

Engel's, , Russia

Izhevsk, , Russia

Kazan', , Russia

Kazan', , Russia

Kursk, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Moscow, , Russia

Saint Petersburg, , Russia

Saint Petersburg, , Russia

Smolensk, , Russia

Stavropol, , Russia

Tver', , Russia

Tyumen, , Russia

Ufa, , Russia

Ulyanovsk, , Russia

Yekaterinburg, , Russia

Jeddah, , Saudi Arabia

Riyadh, , Saudi Arabia

Riyadh, , Saudi Arabia

Banská Bystrica, , Slovakia

Bratislava, , Slovakia

Bratislava, , Slovakia

Košice, , Slovakia

Poprad, , Slovakia

Prešov, , Slovakia

Žilina, , Slovakia

Ljubljana, , Slovenia

Alcorcón, , Spain

Barakaldo, , Spain

Barcelona, , Spain

Castellon, , Spain

Donostia / San Sebastian, , Spain

Donostia / San Sebastian, , Spain

Gijón, , Spain

Las Palmas de Gran Canaria, , Spain

Logroño, , Spain

Madrid, , Spain

Madrid, , Spain

Madrid, , Spain

Manresa, , Spain

Murcia, , Spain

Navarra, , Spain

Ourense, , Spain

Palma de Mallorca, , Spain

Pontevedra, , Spain

Sabadell, Barcelona, , Spain

Sagunto, , Spain

Salamanca, , Spain

Santiago de Compostela, , Spain

Terrassa, , Spain

Terrassa, , Spain

Valencia, , Spain

Vigo, , Spain

Zamora, , Spain

Gothenburg, , Sweden

Jönköping, , Sweden

Kalmar, , Sweden

Karlstad, , Sweden

Malmo, , Sweden

Stockholm, , Sweden

Sundsvall, , Sweden

Vaxjo, , Sweden

Västerås, , Sweden

Aarau, , Switzerland

Baden, , Switzerland

Biel, , Switzerland

Genolier, , Switzerland

Locarno, , Switzerland

Lugano, , Switzerland

Adana, , Turkey (Türkiye)

Ankara, , Turkey (Türkiye)

Countries

Argentina; Australia; Austria; Brazil; Bulgaria; Canada; China; Colombia; Czechia; Ecuador; Egypt; Estonia; Finland; France; Germany; Hong Kong; Hungary; Israel; Italy; Latvia; Lebanon; Lithuania; Mexico; Morocco; Netherlands; Poland; Portugal; Russia; Saudi Arabia; Slovakia; Slovenia; Spain; Sweden; Switzerland; Turkey (Türkiye); United Kingdom

References

Llombart-Cussac A, Pivot X, Biganzoli L, Cortes-Funes H, Pritchard KI, Pierga JY, Smith I, Thomssen C, Srock S, Sampayo M, Cortes J. A prognostic factor index for overall survival in patients receiving first-line chemotherapy for HER2-negative advanced breast cancer: an analysis of the ATHENA trial. Breast. 2014 Oct;23(5):656-62. doi: 10.1016/j.breast.2014.06.017. Epub 2014 Jul 19.

Reference Type: DERIVED

PMID: 25047747 (View on PubMed)

Xu BH, Jiang ZF, Shen ZZ, Guan ZZ, Chen ZD, Cheng Y, Zheng H, Jiang J, Wang XJ, Tong ZS, Qin SK, Luo Y, Yao M, Wang LW, He J. Safety and efficacy of first-line bevacizumab combined with taxane therapy in Chinese patients with HER2-negative locally recurrent or metastatic breast cancer: findings from the ATHENA study. Chin Med J (Engl). 2012 Mar;125(5):764-9.

Reference Type: DERIVED

PMID: 22490570 (View on PubMed)

Other Identifiers

MO19391

Identifier Type: -

Identifier Source: org_study_id