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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00448591
Recruitment Status : Completed
First Posted : March 19, 2007
Results First Posted : May 25, 2015
Last Update Posted : May 25, 2015
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: bevacizumab [Avastin] Drug: Taxane-based chemotherapy Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2296 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2006
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: 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
Drug: Taxane-based chemotherapy
As prescribed

Primary Outcome Measures :
  1. 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 ]
    Adverse events (including laboratory abnormalities) were assessed by the investigator according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) grading systems.

Secondary Outcome Measures :
  1. Percentage of Participants With Disease Progression [ Time Frame: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months ]
    Disease progression was assessed by the investigator per standard clinical practice using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

  2. Time to Progression (TTP) [ Time Frame: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months ]
    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.

  3. Percentage of Participants With Recorded Death [ Time Frame: 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 [ Time Frame: Baseline, Day 1 of Cycle 4, Final Visit and every 3 months during follow-up until death up to 45 months ]
    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.

  5. Percentage of Participants by Best Overall Response to Treatment [ Time Frame: Baseline, Day 1 of Cycle 4, final visit and every 3 months during follow-up until disease progression or death up to 45 months ]
    Best overall response is defined as the best response shown throughout the study. Tumor assessment was performed by the investigator using standard clinical practice.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00448591

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Buenos Aires, Argentina, 1406
Buenos Aires, Argentina, 1878
La Plata, Argentina, B1902CMK
Rosario, Argentina, S2002KDS
Tucuman, Argentina, T4000IAK
Adelaide, Australia, 5000
Darlinghurst, Australia, 2010
East Melbourne, Australia, 3002
Frankston, Australia, 3199
Gosford, Australia, 2250
Lismore, Australia, 2480
Maroochydore, Australia, 4558
Milton, Australia, 4064
Perth, Australia, 6000
Richmond, Australia, 3121
St. Leonards, Australia, 2065
Sydney, Australia, 2031
Sydney, Australia, 2060
Wodonga, Australia, 3690
Bludesch, Austria, 6712
Bregenz, Austria, 6900
Dornbirn, Austria, 6850
Graz, Austria, 8036
Hall in Tirol, Austria, 6060
Innsbruck, Austria, 6020
Klagenfurt, Austria, 9026
Krems, Austria, 3500
Kufstein, Austria, 6330
Leoben, Austria, 8700
Linz, Austria, 4010
Ried-innkreis, Austria, 4910
St Pölten, Austria, 3100
St Veit An Der Glan, Austria, 9300
Steyr, Austria, 4400
Villach, Austria, 9500
Wels, Austria, 4600
Wiener Neustadt, Austria, 2700
Wien, Austria, 1030
Wien, Austria, 1130
Wien, Austria, 1140
Wien, Austria, 1160
Wien, Austria, 1220
Zams, Austria, 6511
Belo Horizonte, Brazil, 30140-083
Belo Horizonte, Brazil, 30150-221
Belo Horizonte, Brazil, 30150-320
Campinas, Brazil, 13060-803
Campinas, Brazil, 13073-400
Curitiba, Brazil, 80530-010
Curitiba, Brazil, 80730-180
Fortaleza, Brazil, 60125-151
Fortaleza, Brazil, 60741-420
Goiania, Brazil, 74075-040
Ijui, Brazil, 98700-000
JAU, Brazil, 17210-080
Joao Pessoa, Brazil, 58040280
Niteroi, Brazil, 24220-007
Piracicaba, Brazil, 13419-155
Porto Alegre, Brazil, 90020-090
Porto Alegre, Brazil, 90035-903
Porto Alegre, Brazil, 90110-270
Porto Alegre, Brazil, 91430-001
Porto Alegre, Brazil
Recife, Brazil, 52012-220
Ribeirao Preto, Brazil, 14025-430
Rio de Janeiro, Brazil, 21941-590
Rio de Janeiro, Brazil, 22031072
Rio de Janeiro, Brazil, 22631-004
Salvador, Brazil, 41950-610
Santos, Brazil, 11075-350
Sao Paulo, Brazil, 01232-010
Sao Paulo, Brazil, 01308-000
Sao Paulo, Brazil, 01308-050
Sao Paulo, Brazil, 01332-000
Sao Paulo, Brazil, 01406100
Sao Paulo, Brazil, 01509-900
Sao Paulo, Brazil, 03102-002
Sao Paulo, Brazil, 05403-010
Sao Paulo, Brazil, 08270-070
Sorocaba, Brazil, 18035-300
Vitoria, Brazil, 29055-270
Plovdiv, Bulgaria, 4004
Sofia, Bulgaria, 1527
Sofia, Bulgaria, 1784
Varna, Bulgaria, 9010
Veliko Tarnovo, Bulgaria, 5000
Canada, British Columbia
Surrey, British Columbia, Canada, V3V 1Z2
Canada, Ontario
Barrie, Ontario, Canada, L4M 6MZ
Brampton, Ontario, Canada, L6R 3J7
East York, Ontario, Canada, M4C 3E7
Mississauga, Ontario, Canada, L5M 2N1
Newmarket, Ontario, Canada, L3Y 2P9
Sault Ste Marie, Ontario, Canada, P6A 2C4
Scarborough, Ontario, Canada, M1P 2V5
St. Catharines, Ontario, Canada, L2R 7C6
Toronto, Ontario, Canada, M2K 1E1
Toronto, Ontario, Canada, M4N 3M5
Toronto, Ontario, Canada, M5B 1W8
Toronto, Ontario, Canada, M5G 2M9
Toronto, Ontario, Canada, M9C 1A5
Windsor, Ontario, Canada, N8W 2X3
Canada, Quebec
Montreal, Quebec, Canada, H2W 1S6
Canada, Saskatchewan
Regina, Saskatchewan, Canada, S4T 7T1
Quebec, Canada, G1S 4L8
Beijing, China, 100021
Beijing, China, 100071
Chang Sha, China, 410006
Changchun, China, 130012
Chengdu, China, 610041
Chongqing, China, 400038
Guangzhou, China, 510060
Hang Zhou, China, 310022
He Fei, China, 230022
Nanjing, China, 210002
Shanghai, China, 200032
Shanghai, China, 200080
Suzhou, China, 215006
Tianjin, China, 300060
Cali, Colombia
Neiva, Colombia
Pereira, Colombia
Czech Republic
Brno, Czech Republic, 656 53
Hradec Kralove, Czech Republic, 500 05
Ostrava, Czech Republic, 708 52
Praha, Czech Republic, 180 81
Quito, Ecuador, EC170125
Alexandria, Egypt, 11737
Tallin, Estonia, 11619
Tartu, Estonia, 50406
Haemeenlinna, Finland, 13530
Kotka, Finland, 48210
Kuopio, Finland, 70211
Pori, Finland, 28500
Tampere, Finland, 33520
Turku, Finland, 20520
Vaasa, Finland, 65130
Ales, France, 30100
Angers, France, 49933
Avignon, France, 84918
Bayonne, France, 64100
Bayonne, France, 64109
Besancon, France, 25030
Bobigny, France, 93009
Bordeaux, France, 33000
Bordeaux, France, 33077
Boulogne Sur Mer, France, 62222
Boulogne-billancourt, France, 92100
Brest, France, 29609
Chalon Sur Saone, France, 71100
Chateauroux, France, 36019
Clermont-ferrand, France, 63023
Colmar, France, 68024
Creteil, France, 94010
DAX, France, 40107
Dijon, France, 21000
GAP, France, 05007
Grenoble, France, 38043
L'isle D'espagnac, France, 16340
La Chaussee St Victor, France, 41260
La Tronche, France, 38700
Le Chesnay, France, 78157
Le Coudray, France, 28630
Le Mans, France, 72000
Lille, France, 59000
Lyon, France, 69437
Mantes La Jolie, France, 78201
Marseille, France, 13285
Marseille, France, 13291
Metz, France, 57038
Metz, France, 57072
Mont-de-marsan, France, 40024
Montbeliard, France, 25209
Montfermeil, France, 93370
Montpellier, France, 34967
Mougins, France, 06250
Nancy, France, 54100
Nevers, France, 58000
Nimes, France, 30900
Niort, France, 79021
Paris, France, 75012
Paris, France, 75231
Paris, France, 75475
Paris, France, 75651
Paris, France, 75908
Paris, France, 75970
Perigueux, France, 24000
Perpignan, France, 66000
Pierre Benite, France, 69310
Pontoise, France, 95300
Reims, France, 51056
Rouen, France, 76038
Saint Brieuc, France, 22015
Saint Gregoire, France, 35768
Saint Jean, France, 31240
Saint Pierre, France, 97448
Saint-cloud, France, 92210
Saint-denis de La Reunion, France, 97400
St-priest-en-jarez, France, 42271
Strasbourg, France, 67065
Strasbourg, France, 67091
Toulon, France, 83056
Toulouse, France, 31052
Toulouse, France, 31078
Tours, France, 37044
Valenciennes, France, 59322
Vandoeuvre Les Nancy, France, 54511
Vannes, France, 56001
Villeneuve-sur-lot, France, 47307
Augsburg, Germany, 86150
Bad Saarow, Germany, 15526
Berlin, Germany, 10117
Berlin, Germany, 13125
Berlin, Germany, 13589
Bielefeld, Germany, 33604
Bochum, Germany, 44787
Böblingen, Germany, 71032
Chemnitz, Germany, 09116
Cottbus, Germany, 03046
Deggendorf, Germany, 94469
Dresden, Germany, 01307
Duisburg, Germany, 47051
Düsseldorf, Germany, 40479
Erfurt, Germany, 99085
Essen, Germany, 45122
Frankfurt, Germany, 65929
Freiburg, Germany, 79106
Halle, Germany, 06120
Hamburg, Germany, 20249
Hamburg, Germany, 22081
Hannover, Germany, 30167
Hannover, Germany, 30559
Kassel, Germany, 34117
Kiel, Germany, 24105
Leipzig, Germany, 04129
Lübeck, Germany, 23562
Magdeburg, Germany, 39108
Magdeburg, Germany, 39130
Mainz, Germany, 55131
Mannheim, Germany, 68167
München, Germany, 80638
Regensburg, Germany, 93053
Rostock, Germany, 18059
Saarbruecken, Germany, 66113
Stralsund, Germany, 18435
Stuttgart, Germany, 70176
Stuttgart, Germany, 70199
Troisdorf, Germany, 53804
ULM, Germany, 89075
Unna, Germany, 59423
Wiesbaden, Germany, 65199
Wuerselen, Germany, 52146
Wuppertal, Germany, 42105
Hong Kong
Hong Kong, Hong Kong, 852
Hong Kong, Hong Kong
Budapest, Hungary, 1082
Budapest, Hungary, 1122
Szeged, Hungary, 6720
Beer Sheva, Israel, 8410101
Haifa, Israel, 34354
Holon, Israel, 58100
Jerusalem, Israel, 91031
Jerusalem, Israel, 91120
Kfar Saba, Israel, 44281
Nahariya, Israel, 22100
Petach Tikva, Israel, 49100
Ramat-gan, Israel, 52621
Rehovot, Israel, 76100
Safed, Israel, 13110
Tel Aviv, Israel, 6423906
Zerifin, Israel, 70300
Ancona, Italy
Aviano, Italy, 33081
Brescia, Italy, 25123
Cagliari, Italy, 09100
Cagliari, Italy, 09121
Candiolo, Italy, 10060
Carpi, Italy, 41012
Castelfranco Veneto, Italy, 31033
Castrovillari, Italy, 87012
Catania, Italy, 95100
Chieti, Italy, 66100
Como, Italy, 22100
Cremona, Italy, 26100
Frattamaggiore, Italy, 80027
Genova, Italy, 16132
Lecce, Italy, 73100
Lido Di Camaiore, Italy, 55043
Lucca, Italy, 55100
Mantova, Italy, 46100
Messina, Italy, 98123
Milano, Italy, 20142
Milano, Italy, 20162
Montevarchi, Italy, 52025
Napoli, Italy, 80131
Novara, Italy, 28100
Palermo, Italy, 90127
Paola, Italy, 87027
Pavia, Italy, 27100
Piove Di Sacco, Italy, 35028
Pordenone, Italy, 33170
Pozzuoli, Italy, 80087
Prato, Italy, 59100
Ravenna, Italy, 48100
Rionero in Vulture, Italy, 85028
Roma, Italy, 00128
Roma, Italy, 00144
Roma, Italy, 00153
Roma, Italy, 00168
Roma, Italy, 00189
Salerno, Italy, 84131
San Giovanni Rotondo, Italy, 71013
Saronno, Italy, 21047
Sassari, Italy, 07100
Siena, Italy, 53100
Torino, Italy, 10126
Verona, Italy, 37126
Vicenza, Italy, 36100
Riga, Latvia, LV 1079
Riga, Latvia, LV-1002
Beirut, Lebanon, 1107 2020
Beirut, Lebanon, 166378
Kaunas, Lithuania, 50009
Klaipeda, Lithuania, 5808
Vilnius, Lithuania, 08660
Chihuahua, Mexico, 31000
Ciudad Juarez, Mexico, 32300
Guadalajara, Mexico, 45200
Leon, Mexico, 37000
Mexico City, Mexico, 06700
Mexico City, Mexico, 07360
Mexico City, Mexico, 14140
Mexico City, Mexico, 97000
Puebla, Mexico, 72240
Tijuana, Mexico, 22320
Rabat, Morocco, 10 000
Rabat, Morocco, 21000
Ac Amsterdam, Netherlands, 1091
Blaricum, Netherlands, 1261 AN
Capelle Ad Yssel, Netherlands, 2906 ZC
Delftzijl, Netherlands, 9934 JD
Doetinchem, Netherlands, 7009 BL
Goes, Netherlands, 4462 RA
Hoofddorp, Netherlands, 2134 TM
Vlissingen, Netherlands, 4382 EE
Zoetermeer, Netherlands, 2275 NA
Bydgoszcz, Poland, 85-796
Lublin, Poland, 20-090
Olsztyn, Poland, 10-226
Poznan, Poland, 61-866
Warszawa, Poland, 00-909
Warszawa, Poland, 02-781
Almada, Portugal, 2801-951
Aveiro, Portugal, 3814-501
Barreiro, Portugal, 2830-094
Beja, Portugal, 7801-849
Cascais, Portugal, 2750-349
Coimbra, Portugal, 3000-061
Lisboa, Portugal, 1150-199
Lisboa, Portugal, 1649-035
Lisboa, Portugal, 1998-018
Porto, Portugal, 4099-001
Porto, Portugal, 4200-072
Porto, Portugal, 4200-319
Santa Maria Da Feira, Portugal, 4520-211
Santarém, Portugal, 2005-177
Setubal, Portugal, 2910-446
Vila Nova de Gaia, Portugal, 4434-502
Russian Federation
Balashikha, Russian Federation, 143900
Barnaul, Russian Federation, 656049
Ekaterinburg, Russian Federation, 620905
Engels, Russian Federation, 413115
Izhevsk, Russian Federation, 426009
Kazan, Russian Federation, 420029
Kazan, Russian Federation, 420111
Kursk, Russian Federation, 305035
Moscow, Russian Federation, 107005
Moscow, Russian Federation, 115478
Moscow, Russian Federation, 121356
Moscow, Russian Federation, 125284
Moscow, Russian Federation, 143423
Smolensk, Russian Federation, 214000
St Petersburg, Russian Federation, 197022
St Petersburg, Russian Federation, 197758
Stavropol, Russian Federation, 355047
Tumen, Russian Federation, 625047
Tver, Russian Federation, 170008
UFA, Russian Federation, 450054
Ulyanovsk, Russian Federation, ND
Saudi Arabia
Jeddah, Saudi Arabia, 21499
Riyadh, Saudi Arabia, 11211
Riyadh, Saudi Arabia, 22490
Banska Bystrica, Slovakia, 975 17
Bratislava, Slovakia, 812 50
Bratislava, Slovakia, 831 01
Kosice, Slovakia, 041 90
Poprad, Slovakia, 05801
Presov, Slovakia, 080 01
Zilina, Slovakia, 012 07
Ljubljana, Slovenia, 1000
Alcorcon, Spain, 28922
Barakaldo, Spain, 48903
Barcelona, Spain, 08029
Castellon, Spain, 12002
Gijon, Spain, 33394
Las Palmas de Gran Canaria, Spain, 35016
Logroño, Spain, 26001
Madrid, Spain, 28041
Madrid, Spain, 28905
Madrid, Spain, 28943
Manresa, Spain, 08243
Murcia, Spain, 30008
Navarra, Spain, 31008
Orense, Spain, 32005
Palma de Mallorca, Spain, 07014
Pontevedra, Spain, 36002
Sabadell, Barcelona, Spain, 08208
Sagunto, Spain, 46520
Salamanca, Spain, 37007
San Sebastian, Spain, 20012
San Sebastian, Spain, 20080
Santiago de Compostela, Spain, 15706
Terrassa, Spain, 08221
Terrassa, Spain, 08227
Valencia, Spain, 46026
Vigo, Spain, 36204
Zamora, Spain, 49021
Göteborg, Sweden, 41345
Jonkoping, Sweden, 55185
Kalmar, Sweden, 39185
Karlstad, Sweden, 65185
Malmoe, Sweden, 20502
Stockholm, Sweden, 11486
Sundsvall, Sweden, 85186
Vaxjo, Sweden, 35185
Västerås, Sweden, 72189
Aarau, Switzerland, 5000
Baden, Switzerland, 5404
Biel, Switzerland, 2502
Genolier, Switzerland, 1272
Locarno, Switzerland, 6601
Lugano, Switzerland, 6900
Adana, Turkey, 01330
Ankara, Turkey, 06230
Gaziantep, Turkey, 27310
Istanbul, Turkey, 34300
Istanbul, Turkey, 34390
Shhiye, Ankara, Turkey, 06100
United Kingdom
Colchester, United Kingdom, CO3 3NB
Coventry, United Kingdom, CV2 2DX
Dundee, United Kingdom, DD1 9SY
Glasgow, United Kingdom, G11 6NT
London, United Kingdom, W6 8RF
Peterborough, United Kingdom, PE 3 9GZ
Sutton, United Kingdom, SM2 5PT
Truro, United Kingdom, TR1 3LJ
Westcliffe-on-sea, United Kingdom, SS0 0RY
Worthing, United Kingdom, B11 2DH
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00448591     History of Changes
Other Study ID Numbers: MO19391
First Posted: March 19, 2007    Key Record Dates
Results First Posted: May 25, 2015
Last Update Posted: May 25, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents