AzTrials
AzTrials

Breast CancerPhase 3NCT00448591

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

A Phase 3 study testing bevacizumab [Avastin] and Taxane-based chemotherapy in people with Breast Cancer, run by Hoffmann-La Roche at 457 sites in 36 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
bevacizumab [Avastin] and Taxane-based chemotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,296 participants
Where
457 sitesin 36 countries
Study dates
Sep 2006to Feb 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

457 sites in 36 countries.

457 sites in 36 countries

France72 sites

  • Study site

    Alès, 30100

  • Study site

    Angers, 49933

  • Study site

    Avignon, 84918

  • Study site

    Bayonne, 64100

  • Study site

    Bayonne, 64109

  • Study site

    Besançon, 25030

  • Study site

    Bobigny, 93009

  • Study site

    Bordeaux, 33000

  • Study site

    Bordeaux, 33077

  • Study site

    Boulogne-Billancourt, 92100

  • Study site

    Boulogne-sur-Mer, 62222

  • Study site

    Brest, 29609

  • Study site

    Chalon-sur-Saône, 71100

  • Study site

    Châteauroux, 36019

  • Study site

    Clermont-Ferrand, 63023

  • Study site

    Colmar, 68024

  • Study site

    Créteil, 94010

  • Study site

    Dax, 40107

  • Study site

    Dijon, 21000

  • Study site

    Gap, 05007

  • Study site

    Grenoble, 38043

  • Study site

    La Chaussée-Saint-Victor, 41260

  • Study site

    La Tronche, 38700

  • Study site

    Le Chesnay, 78157

  • Study site

    Le Coudray, 28630

  • Study site

    Le Mans, 72000

  • Study site

    Lille, 59000

  • Study site

    LIsle-dEspagnac, 16340

  • Study site

    Lyon, 69437

  • Study site

    Mantes-la-Jolie, 78201

  • Study site

    Marseille, 13285

  • Study site

    Marseille, 13291

  • Study site

    Metz, 57038

  • Study site

    Metz, 57072

  • Study site

    Mont-de-Marsan, 40024

  • Study site

    Montbéliard, 25209

  • Study site

    Montfermeil, 93370

  • Study site

    Montpellier, 34967

  • Study site

    Mougins, 06250

  • Study site

    Nancy, 54100

  • Study site

    Nevers, 58000

  • Study site

    Nîmes, 30900

  • Study site

    Niort, 79021

  • Study site

    Paris, 75012

  • Study site

    Paris, 75231

  • Study site

    Paris, 75475

  • Study site

    Paris, 75651

  • Study site

    Paris, 75908

  • Study site

    Paris, 75970

  • Study site

    Périgueux, 24000

  • Study site

    Perpignan, 66000

  • Study site

    Pierre-Bénite, 69310

  • Study site

    Pontoise, 95300

  • Study site

    Reims, 51056

  • Study site

    Rouen, 76038

  • Study site

    Saint-Brieuc, 22015

  • Study site

    Saint-Cloud, 92210

  • Study site

    Saint-denis de La Reunion, 97400

  • Study site

    Saint-Grégoire, 35768

  • Study site

    Saint-Jean, 31240

  • Study site

    Saint-Pierre, 97448

  • Study site

    Saint-Priest-en-Jarez, 42271

  • Study site

    Strasbourg, 67065

  • Study site

    Strasbourg, 67091

  • Study site

    Toulon, 83056

  • Study site

    Toulouse, 31052

  • Study site

    Toulouse, 31078

  • Study site

    Tours, 37044

  • Study site

    Valenciennes, 59322

  • Study site

    Vandœuvre-lès-Nancy, 54511

  • Study site

    Vannes, 56001

  • Study site

    Villeneuve-sur-Lot, 47307

Other trials in France

Italy47 sites

  • Study site

    Ancona

  • Study site

    Aviano, 33081

  • Study site

    Brescia, 25123

  • Study site

    Cagliari, 09100

  • Study site

    Cagliari, 09121

  • Study site

    Candiolo, 10060

  • Study site

    Carpi, 41012

  • Study site

    Castelfranco Veneto, 31033

  • Study site

    Castrovillari, 87012

  • Study site

    Catania, 95100

  • Study site

    Chieti, 66100

  • Study site

    Como, 22100

  • Study site

    Cremona, 26100

  • Study site

    Frattamaggiore, 80027

  • Study site

    Genova, 16132

  • Study site

    Lecce, 73100

  • Study site

    Lido di Camaiore, 55043

  • Study site

    Lucca, 55100

  • Study site

    Mantua, 46100

  • Study site

    Messina, 98123

  • Study site

    Milan, 20142

  • Study site

    Milan, 20162

  • Study site

    Montevarchi, 52025

  • Study site

    Naples, 80131

  • Study site

    Novara, 28100

  • Study site

    Palermo, 90127

  • Study site

    Paola, 87027

  • Study site

    Pavia, 27100

  • Study site

    Piove di Sacco, 35028

  • Study site

    Pordenone, 33170

  • Study site

    Pozzuoli, 80087

  • Study site

    Prato, 59100

  • Study site

    Ravenna, 48100

  • Study site

    Rionero in Vulture, 85028

  • Study site

    Roma, 00128

  • Study site

    Roma, 00144

  • Study site

    Roma, 00153

  • Study site

    Roma, 00168

  • Study site

    Roma, 00189

  • Study site

    Salerno, 84131

  • Study site

    San Giovanni Rotondo, 71013

  • Study site

    Saronno, 21047

  • Study site

    Sassari, 07100

  • Study site

    Siena, 53100

  • Study site

    Torino, 10126

  • Study site

    Verona, 37126

  • Study site

    Vicenza, 36100

Other trials in Italy

Germany44 sites

  • Study site

    Augsburg, 86150

  • Study site

    Bad Saarow, 15526

  • Study site

    Berlin, 10117

  • Study site

    Berlin, 13125

  • Study site

    Berlin, 13589

  • Study site

    Bielefeld, 33604

  • Study site

    Böblingen, 71032

  • Study site

    Bochum, 44787

  • Study site

    Chemnitz, 09116

  • Study site

    Cottbus, 03046

  • Study site

    Deggendorf, 94469

  • Study site

    Dresden, 01307

  • Study site

    Duisburg, 47051

  • Study site

    Düsseldorf, 40479

  • Study site

    Erfurt, 99085

  • Study site

    Essen, 45122

  • Study site

    Frankfurt, 65929

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Halle, 06120

  • Study site

    Hamburg, 20249

  • Study site

    Hamburg, 22081

  • Study site

    Hanover, 30167

  • Study site

    Hanover, 30559

  • Study site

    Kassel, 34117

  • Study site

    Kiel, 24105

  • Study site

    Leipzig, 04129

  • Study site

    Lübeck, 23562

  • Study site

    Magdeburg, 39108

  • Study site

    Magdeburg, 39130

  • Study site

    Mainz, 55131

  • Study site

    Mannheim, 68167

  • Study site

    München, 80638

  • Study site

    Regensburg, 93053

  • Study site

    Rostock, 18059

  • Study site

    Saarbrücken, 66113

  • Study site

    Stralsund, 18435

  • Study site

    Stuttgart, 70176

  • Study site

    Stuttgart, 70199

  • Study site

    Troisdorf, 53804

  • Study site

    Ulm, 89075

  • Study site

    Unna, 59423

  • Study site

    Wiesbaden, 65199

  • Study site

    Wuppertal, 42105

  • Study site

    Würselen, 52146

Other trials in Germany

Brazil38 sites

  • Study site

    Belo Horizonte, 30140-083

  • Study site

    Belo Horizonte, 30150-221

  • Study site

    Belo Horizonte, 30150-320

  • Study site

    Campinas, 13060-803

  • Study site

    Campinas, 13073-400

  • Study site

    Curitiba, 80530-010

  • Study site

    Curitiba, 80730-180

  • Study site

    Fortaleza, 60125-151

  • Study site

    Fortaleza, 60741-420

  • Study site

    Goiânia, 74075-040

  • Study site

    Ijuí, 98700-000

  • Study site

    Jaú, 17210-080

  • Study site

    João Pessoa, 58040280

  • Study site

    Niterói, 24220-007

  • Study site

    Piracicaba, 13419-155

  • Study site

    Porto Alegre, 90020-090

  • Study site

    Porto Alegre, 90035-903

  • Study site

    Porto Alegre, 90110-270

  • Study site

    Porto Alegre, 91430-001

  • Study site

    Porto Alegre

  • Study site

    Recife, 52012-220

  • Study site

    Ribeirão Preto, 14025-430

  • Study site

    Rio de Janeiro, 21941-590

  • Study site

    Rio de Janeiro, 22031072

  • Study site

    Rio de Janeiro, 22631-004

  • Study site

    Salvador, 41950-610

  • Study site

    Santos, 11075-350

  • Study site

    São Paulo, 01232-010

  • Study site

    São Paulo, 01308-000

  • Study site

    São Paulo, 01308-050

  • Study site

    São Paulo, 01332-000

  • Study site

    São Paulo, 01406100

  • Study site

    São Paulo, 01509-900

  • Study site

    São Paulo, 03102-002

  • Study site

    São Paulo, 05403-010

  • Study site

    São Paulo, 08270-070

  • Study site

    Sorocaba, 18035-300

  • Study site

    Vitória, 29055-270

Other trials in Brazil

Spain27 sites

  • Study site

    Alcorcón, 28922

  • Study site

    Barakaldo, 48903

  • Study site

    Barcelona, 08029

  • Study site

    Castellon, 12002

  • Study site

    Donostia / San Sebastian, 20012

  • Study site

    Donostia / San Sebastian, 20080

  • Study site

    Gijón, 33394

  • Study site

    Las Palmas de Gran Canaria, 35016

  • Study site

    Logroño, 26001

  • Study site

    Madrid, 28041

  • Study site

    Madrid, 28905

  • Study site

    Madrid, 28943

  • Study site

    Manresa, 08243

  • Study site

    Murcia, 30008

  • Study site

    Navarra, 31008

  • Study site

    Ourense, 32005

  • Study site

    Palma de Mallorca, 07014

  • Study site

    Pontevedra, 36002

  • Study site

    Sabadell, Barcelona, 08208

  • Study site

    Sagunto, 46520

  • Study site

    Salamanca, 37007

  • Study site

    Santiago de Compostela, 15706

  • Study site

    Terrassa, 08221

  • Study site

    Terrassa, 08227

  • Study site

    Valencia, 46026

  • Study site

    Vigo, 36204

  • Study site

    Zamora, 49021

Other trials in Spain

Austria24 sites

  • Study site

    Bludesch, 6712

  • Study site

    Bregenz, 6900

  • Study site

    Dornbirn, 6850

  • Study site

    Graz, 8036

  • Study site

    Hall in Tirol, 6060

  • Study site

    Innsbruck, 6020

  • Study site

    Klagenfurt, 9026

  • Study site

    Krems, 3500

  • Study site

    Kufstein, 6330

  • Study site

    Leoben, 8700

  • Study site

    Linz, 4010

  • Study site

    Ried-innkreis, 4910

  • Study site

    Sankt Pölten, 3100

  • Study site

    Sankt Veit an der Glan, 9300

  • Study site

    Steyr, 4400

  • Study site

    Vienna, 1030

  • Study site

    Vienna, 1130

  • Study site

    Vienna, 1140

  • Study site

    Vienna, 1160

  • Study site

    Vienna, 1220

  • Study site

    Villach, 9500

  • Study site

    Wels, 4600

  • Study site

    Wiener Neustadt, 2700

  • Study site

    Zams, 6511

Other trials in Austria

Russia21 sites

  • Study site

    Balashikha, 143900

  • Study site

    Barnaul, 656049

  • Study site

    Engel's, 413115

  • Study site

    Izhevsk, 426009

  • Study site

    Kazan', 420029

  • Study site

    Kazan', 420111

  • Study site

    Kursk, 305035

  • Study site

    Moscow, 107005

  • Study site

    Moscow, 115478

  • Study site

    Moscow, 121356

  • Study site

    Moscow, 125284

  • Study site

    Moscow, 143423

  • Study site

    Saint Petersburg, 197022

  • Study site

    Saint Petersburg, 197758

  • Study site

    Smolensk, 214000

  • Study site

    Stavropol, 355047

  • Study site

    Tver', 170008

  • Study site

    Tyumen, 625047

  • Study site

    Ufa, 450054

  • Study site

    Ulyanovsk, ND

  • Study site

    Yekaterinburg, 620905

Other trials in Russia

Canada18 sites

  • Study site

    Barrie, Ontario, L4M 6MZ

  • Study site

    Brampton, Ontario, L6R 3J7

  • Study site

    East York, Ontario, M4C 3E7

  • Study site

    Mississauga, Ontario, L5M 2N1

  • Study site

    Montreal, Quebec, H2W 1S6

  • Study site

    Newmarket, Ontario, L3Y 2P9

  • Study site

    Québec, Quebec, G1S 4L8

  • Study site

    Regina, Saskatchewan, S4T 7T1

  • Study site

    Sault Ste. Marie, Ontario, P6A 2C4

  • Study site

    Scarborough Village, Ontario, M1P 2V5

  • Study site

    St. Catharines, Ontario, L2R 7C6

  • Study site

    Surrey, British Columbia, V3V 1Z2

  • Study site

    Toronto, Ontario, M2K 1E1

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Toronto, Ontario, M5B 1W8

  • Study site

    Toronto, Ontario, M5G 2M9

  • Study site

    Toronto, Ontario, M9C 1A5

  • Study site

    Windsor, Ontario, N8W 2X3

Other trials in Canada

Portugal16 sites

  • Study site

    Almada, 2801-951

  • Study site

    Aveiro, 3814-501

  • Study site

    Barreiro, 2830-094

  • Study site

    Beja, 7801-849

  • Study site

    Cascais, 2750-349

  • Study site

    Coimbra, 3000-061

  • Study site

    Lisbon, 1150-199

  • Study site

    Lisbon, 1649-035

  • Study site

    Lisbon, 1998-018

  • Study site

    Porto, 4099-001

  • Study site

    Porto, 4200-072

  • Study site

    Porto, 4200-319

  • Study site

    Santa Maria da Feira, 4520-211

  • Study site

    Santarém, 2005-177

  • Study site

    Setúbal, 2910-446

  • Study site

    Vila Nova de Gaia, 4434-502

Other trials in Portugal

Australia14 sites

  • Study site

    Adelaide, 5000

  • Study site

    Darlinghurst, 2010

  • Study site

    East Melbourne, 3002

  • Study site

    Frankston, 3199

  • Study site

    Gosford, 2250

  • Study site

    Lismore, 2480

  • Study site

    Maroochydore, 4558

  • Study site

    Milton, 4064

  • Study site

    Perth, 6000

  • Study site

    Richmond, 3121

  • Study site

    St Leonards, 2065

  • Study site

    Sydney, 2031

  • Study site

    Sydney, 2060

  • Study site

    Wodonga, 3690

Other trials in Australia

China14 sites

  • Study site

    Beijing, 100021

  • Study site

    Beijing, 100071

  • Study site

    Changchun, 130012

  • Study site

    Changsha, 410006

  • Study site

    Chengdu, 610041

  • Study site

    Chongqing, 400038

  • Study site

    Guangzhou, 510060

  • Study site

    Hangzhou, 310022

  • Study site

    Hefei, 230022

  • Study site

    Nanjing, 210002

  • Study site

    Shanghai, 200032

  • Study site

    Shanghai, 200080

  • Study site

    Suzhou, 215006

  • Study site

    Tianjin, 300060

Other trials in China

Israel13 sites

  • Study site

    Beersheba, 8410101

  • Study site

    Haifa, 34354

  • Study site

    Holon, 58100

  • Study site

    Jerusalem, 91031

  • Study site

    Jerusalem, 91120

  • Study site

    Kfar Saba, 44281

  • Study site

    Nahariya, 22100

  • Study site

    Petah Tikva, 49100

  • Study site

    Ramat Gan, 52621

  • Study site

    Rehovot, 76100

  • Study site

    Safed, 13110

  • Study site

    Tel Aviv, 6423906

  • Study site

    Tsrifin, 70300

Other trials in Israel

Mexico10 sites

  • Study site

    Chihuahua City, 31000

  • Study site

    Ciudad Juárez, 32300

  • Study site

    Guadalajara, 45200

  • Study site

    León, 37000

  • Study site

    Mexico City, 06700

  • Study site

    Mexico City, 07360

  • Study site

    Mexico City, 14140

  • Study site

    Mexico City, 97000

  • Study site

    Puebla City, 72240

  • Study site

    Tijuana, 22320

Other trials in Mexico

United Kingdom10 sites

  • Study site

    Colchester, CO3 3NB

  • Study site

    Coventry, CV2 2DX

  • Study site

    Dundee, DD1 9SY

  • Study site

    Glasgow, G11 6NT

  • Study site

    London, W6 8RF

  • Study site

    Peterborough, PE 3 9GZ

  • Study site

    Sutton, SM2 5PT

  • Study site

    Truro, TR1 3LJ

  • Study site

    Westcliffe-on-sea, SS0 0RY

  • Study site

    Worthing, B11 2DH

Other trials in United Kingdom

Netherlands9 sites

  • Study site

    Ac Amsterdam, 1091

  • Study site

    Blaricum, 1261 AN

  • Study site

    Capelle Ad Yssel, 2906 ZC

  • Study site

    Delftzijl, 9934 JD

  • Study site

    Doetinchem, 7009 BL

  • Study site

    Flushing, 4382 EE

  • Study site

    Goes, 4462 RA

  • Study site

    Hoofddorp, 2134 TM

  • Study site

    Zoetermeer, 2275 NA

Other trials in Netherlands

Sweden9 sites

  • Study site

    Gothenburg, 41345

  • Study site

    Jönköping, 55185

  • Study site

    Kalmar, 39185

  • Study site

    Karlstad, 65185

  • Study site

    Malmö, 20502

  • Study site

    Stockholm, 11486

  • Study site

    Sundsvall, 85186

  • Study site

    Västerås, 72189

  • Study site

    Vaxjo, 35185

Other trials in Sweden

Finland7 sites

  • Study site

    Hämeenlinna, 13530

  • Study site

    Kotka, 48210

  • Study site

    Kuopio, 70211

  • Study site

    Pori, 28500

  • Study site

    Tampere, 33520

  • Study site

    Turku, 20520

  • Study site

    Vaasa, 65130

Other trials in Finland

Slovakia7 sites

  • Study site

    Banská Bystrica, 975 17

  • Study site

    Bratislava, 812 50

  • Study site

    Bratislava, 831 01

  • Study site

    Košice, 041 90

  • Study site

    Poprad, 05801

  • Study site

    Prešov, 080 01

  • Study site

    Žilina, 012 07

Other trials in Slovakia

Poland6 sites

  • Study site

    Bydgoszcz, 85-796

  • Study site

    Lublin, 20-090

  • Study site

    Olsztyn, 10-226

  • Study site

    Poznan, 61-866

  • Study site

    Warsaw, 00-909

  • Study site

    Warsaw, 02-781

Other trials in Poland

Switzerland6 sites

  • Study site

    Aarau, 5000

  • Study site

    Baden, 5404

  • Study site

    Biel, 2502

  • Study site

    Genolier, 1272

  • Study site

    Locarno, 6601

  • Study site

    Lugano, 6900

Other trials in Switzerland

Turkey (Türkiye)6 sites

  • Study site

    Adana, 01330

  • Study site

    Ankara, 06230

  • Study site

    Gaziantep, 27310

  • Study site

    Istanbul, 34300

  • Study site

    Istanbul, 34390

  • Study site

    Shhiye, Ankara, 06100

Other trials in Turkey (Türkiye)

Argentina5 sites

  • Study site

    Buenos Aires, 1406

  • Study site

    Buenos Aires, 1878

  • Study site

    La Plata, B1902CMK

  • Study site

    Rosario, S2002KDS

  • Study site

    San Miguel de Tucumán, T4000IAK

Other trials in Argentina

Bulgaria5 sites

  • Study site

    Plovdiv, 4004

  • Study site

    Sofia, 1527

  • Study site

    Sofia, 1784

  • Study site

    Varna, 9010

  • Study site

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Czechia4 sites

  • Study site

    Brno, 656 53

  • Study site

    Hradec Králové, 500 05

  • Study site

    Ostrava, 708 52

  • Study site

    Prague, 180 81

Other trials in Czechia

Colombia3 sites

  • Study site

    Cali

  • Study site

    Neiva

  • Study site

    Pereira

Other trials in Colombia

Hungary3 sites

  • Study site

    Budapest, 1082

  • Study site

    Budapest, 1122

  • Study site

    Szeged, 6720

Other trials in Hungary

Lithuania3 sites

  • Study site

    Kaunas, 50009

  • Study site

    Klaipėda, 5808

  • Study site

    Vilnius, 08660

Other trials in Lithuania

Saudi Arabia3 sites

  • Study site

    Jeddah, 21499

  • Study site

    Riyadh, 11211

  • Study site

    Riyadh, 22490

Other trials in Saudi Arabia

Estonia2 sites

  • Study site

    Tallinn, 11619

  • Study site

    Tartu, 50406

Other trials in Estonia

Hong Kong2 sites

  • Study site

    Hong Kong, 852

  • Study site

    Hong Kong

Other trials in Hong Kong

Latvia2 sites

  • Study site

    Riga, LV 1079

  • Study site

    Riga, LV-1002

Other trials in Latvia

Lebanon2 sites

  • Study site

    Beirut, 1107 2020

  • Study site

    Beirut, 166378

Other trials in Lebanon

Morocco2 sites

  • Study site

    Rabat, 10 000

  • Study site

    Rabat, 21000

Other trials in Morocco

Ecuador1 site

  • Study site

    Quito, EC170125

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Egypt1 site

  • Study site

    Alexandria, 11737

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Slovenia1 site

  • Study site

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: An Open-label Study to Evaluate the Safety and Effect on Disease Progression and Overall Survival of Avastin Plus Taxane-based Chemotherapy in Patients With Locally Recurrent or Metastatic Breast Cancer

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
Being tested
bevacizumab [Avastin], Taxane-based chemotherapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bevacizumab [Avastin]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 chemotherapyDrug

    As prescribed

Study groups in NCT00448591
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: bevacizumab [Avastin]; Drug: Taxane-based chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs)

    Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.

    Measured: Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion

Secondary outcomes (5)

  1. Percentage of Participants With Disease Progression

    Disease progression was assessed by the investigator per standard clinical practice using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

    Measured: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months

  2. Time to Progression (TTP)

    TTP was defined as the time period from the start of first-line therapy to investigator-assessed disease progression. Tumor assessments were performed according to standard clinical practice using NCI criteria. Participants who had not progressed at the time of analysis (including those who died before progressive disease [PD]) or who were lost to follow-up were censored at the last bevacizumab administration date. Time to disease progression was determined by Kaplan-Meier estimates.

    Measured: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months

  3. Percentage of Participants With Recorded Death

    Measured: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months

  4. Overall Survival

    Overall Survival was defined as the time from start of first-line therapy to death due to any cause. Participants for whom no death was captured in the clinical database were censored at the last date they were known to be alive. Median time to overall survival was calculated by Kaplan Meier estimates.

    Measured: Baseline, Day 1 of Cycle 4, Final Visit and every 3 months during follow-up until death up to 45 months

  5. Percentage of Participants by Best Overall Response to Treatment

    Best overall response is defined as the best response shown throughout the study. Tumor assessment was performed by the investigator using standard clinical practice.

    Measured: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2007 (estimated)
  2. Study startSep 2006
  3. Primary completionFeb 2013
  4. Study completionFeb 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2,296 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00448591
Sponsor's protocol ID
MO19391
Status last verified
May 2015
First submitted
16 Mar 2007
Last updated
25 May 2015

Publications

  • 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.

    PubMed 25047747

  • 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.

    PubMed 22490570

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing bevacizumab [Avastin] and Taxane-based chemotherapy in people with Breast Cancer, run by Hoffmann-La Roche at 457 sites in 36 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 457 sites in France, Italy, Germany, Brazil, Spain and 31 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) Related to Bevacizumab, Death, and AEs of Special Interest (AESIs) (time frame: Day 1 of Cycles 1, 2, 3, 4, 5, and 6 up to 6 months after the last bevacizumab infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00448591, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2015.

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