AzTrials
AzTrials

Breast CancerPhase 3NCT00528567

BEATRICE Study: A Study of Bevacizumab (Avastin) Adjuvant Therapy in Triple Negative Breast Cancer

A Phase 3 study testing Bevacizumab and Standard adjuvant chemotherapy in people with Breast Cancer, run by Hoffmann-La Roche at 403 sites in 40 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

The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab. 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 and Standard adjuvant chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,591 participants
Where
403 sitesin 40 countries
Study dates
Dec 2007to Jun 2014
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

  • adult patients, >=18 years of age;
  • operable primary invasive breast cancer;
  • completed definitive loco-regional surgery;
  • primary tumor centrally confirmed as triple negative.

Who cannot join

  • locally advanced breast cancers;
  • previous breast cancer history;
  • clinically significant cardiovascular disease.

Trial locations and contacts

403 sites in 40 countries.

403 sites in 40 countries

United States44 sites

  • Study site

    Abingdon, Virginia, 24211

  • Study site

    Atlanta, Georgia, 30318

  • Study site

    Augusta, Georgia, 30901

  • Study site

    Austin, Texas, 78759

  • Study site

    Bakersfield, California, 93309

  • Study site

    Baltimore, Maryland, 21215

  • Study site

    Baltimore, Maryland, 21237

  • Study site

    Brownstown, Michigan, 48183

  • Study site

    Chattanooga, Tennessee, 37404

  • Study site

    Cincinnati, Ohio, 45242

  • Study site

    Columbia, South Carolina, 29210

  • Study site

    Columbus, Ohio, 43235

  • Study site

    Dallas, Texas, 75234

  • Study site

    Fairfield, Connecticut, 06824

  • Study site

    Fayetteville, Arkansas, 72703

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Gainesville, Florida, 32605

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Greenbrae, California, 94904

  • Study site

    Hickory, North Carolina, 28602

  • Study site

    Huntsville, Alabama, 35805

  • Study site

    Iowa City, Iowa, 52242

  • Study site

    Kalamazoo, Michigan, 49007

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Lawrenceville, Georgia, 30046

  • Study site

    Long Branch, New Jersey, 07740

  • Study site

    Los Angeles, California, 90057

  • Study site

    Middletown, Ohio, 45042

  • Study site

    Mobile, Alabama, 36604

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    Niles, Illinois, 60714

  • Study site

    Orlando, Florida, 32806

  • Study site

    Pleasant Hill, California, 94523

  • Study site

    Richmond, Virginia, 23230

  • Study site

    Rockville, Maryland, 20850-3348

  • Study site

    Rutland, Vermont, 05701

  • Study site

    Southfield, Michigan, 48075-3707

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Stamford, Connecticut, 06902

  • Study site

    Tamarac, Florida, 33321

  • Study site

    The Bronx, New York, 10469

  • Study site

    Washington D.C., District of Columbia, 20010

  • Study site

    Waterloo, Iowa, 50702

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

Germany39 sites

  • Study site

    Berlin, 10317

  • Study site

    Berlin, 14195

  • Study site

    Bielefeld, 33604

  • Study site

    Bonn, 53111

  • Study site

    Chemnitz, 09116

  • Study site

    Coburg, 96450

  • Study site

    Cologne, 50924

  • Study site

    Dortmund, 44137

  • Study site

    Dresden, 01307

  • Study site

    Düsseldorf, 40225

  • Study site

    Frankfurt am Main, 60389

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Georgsmarienhütte, 49124

  • Study site

    Greifswald, 17475

  • Study site

    Hamburg, 20246

  • Study site

    Hamburg, 20357

  • Study site

    Heidelberg, 69115

  • Study site

    Herne, 44625

  • Study site

    Kassel, 34117

  • Study site

    Kiel, 24105

  • Study site

    Krefeld, 47805

  • Study site

    Leipzig, 04129

  • Study site

    Lemgo, 32657

  • Study site

    Lüneburg, 21339

  • Study site

    Magdeburg, 39108

  • Study site

    Marburg, 35043

  • Study site

    München, 81925

  • Study site

    Münster, 48149

  • Study site

    Offenbach, 63069

  • Study site

    Offenburg, 77654

  • Study site

    Recklinghausen, 45657

  • Study site

    Rosenheim, 83022

  • Study site

    Stade, 21680

  • Study site

    Trier, 54290

  • Study site

    Tübingen, 72076

  • Study site

    Ulm, 89075

  • Study site

    Weißenfels, 06667

  • Study site

    Wiesbaden, 65199

  • Study site

    Witten, 58452

Other trials in Germany

Italy32 sites

  • Study site

    Aviano, 33081

  • Study site

    Bari, 70126

  • Study site

    Bergamo, 24128

  • Study site

    Brescia, 25123

  • Study site

    Brindisi, 72100

  • Study site

    Candiolo, 10060

  • Study site

    Cattolica, 47841

  • Study site

    Cesena, 47023

  • Study site

    Fano, 61032

  • Study site

    Genova, 16142

  • Study site

    Lecce, 73100

  • Study site

    Lido di Camaiore, 55043

  • Study site

    Livorno, 57100

  • Study site

    Lugo

  • Study site

    Mantua, 46100

  • Study site

    Noale, 30033

  • Study site

    Padova, 35128

  • Study site

    Palermo, 90146

  • Study site

    Parma, 43100

  • Study site

    Pavia, 27100

  • Study site

    Potenza, 85100

  • Study site

    Ravenna, 48100

  • Study site

    Rimini, 47037

  • Study site

    Roma, 00144

  • Study site

    Roma, 00158

  • Study site

    Roma, 00161

  • Study site

    Rozzano, 20089

  • Study site

    San Giovanni Rotondo, 71013

  • Study site

    Sassari, 07100

  • Study site

    Taormina, 98039

  • Study site

    Treviglio, 24047

  • Study site

    Vecchiazzano, 47100

Other trials in Italy

United Kingdom32 sites

  • Study site

    Belfast, BT9 7AB

  • Study site

    Birmingham, B15 2TT

  • Study site

    Bournemouth, BH7 7DW

  • Study site

    Brighton, BN2 5BE

  • Study site

    Bristol, BS2 8ED

  • Study site

    Cambridge, CB2 2QQ

  • Study site

    Cardiff, CF14 2TL

  • Study site

    Chelsmford, CM1 7ET

  • Study site

    Colchester, CO3 3NB

  • Study site

    Dundee, DD1 9SY

  • Study site

    Edinburgh, EH4 2XU

  • Study site

    Epping, CM16 6TN

  • Study site

    Exeter, EX2 5DW

  • Study site

    Glasgow, G12 0YN

  • Study site

    Guildford, GU2 5XX

  • Study site

    Huddersfield, HD3 3EA

  • Study site

    Ipswich, IP4 5PD

  • Study site

    Leeds, LS9 7TF

  • Study site

    London, EC1 A7BE

  • Study site

    London, NW3 2QG

  • Study site

    London, SE1 9RT

  • Study site

    London, W2 1NY

  • Study site

    Manchester, M20 4BX

  • Study site

    Merseyside, CH63 45Y

  • Study site

    Newcastle upon Tyne, NE4 6BE

  • Study site

    Northwood, HA6 2RN

  • Study site

    Peterborough, PE 3 9GZ

  • Study site

    Sheffield, S1O 2SJ

  • Study site

    Southampton, SO16 6YD

  • Study site

    Stoke-on-Trent, ST4 7LN

  • Study site

    Truro, TR1 3LJ

  • Study site

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

France29 sites

  • Study site

    Angers, 49933

  • Study site

    Bayonne, 64100

  • Study site

    Besançon, 25030

  • Study site

    Bobigny, 93009

  • Study site

    Bordeaux, 33077

  • Study site

    Brest, 29609

  • Study site

    Clermont-Ferrand, 63050

  • Study site

    Colmar, 68024

  • Study site

    Grenoble, 38100

  • Study site

    La Chaussée-Saint-Victor, 41260

  • Study site

    Le Mans, 72000

  • Study site

    Lille, 59000

  • Study site

    Lille, 59020

  • Study site

    Limoges, 87039

  • Study site

    Marseille, 13285

  • Study site

    Montbéliard, 25209

  • Study site

    Montpellier, 34298

  • Study site

    Mougins, 6250

  • Study site

    Nancy, 54100

  • Study site

    Neuilly-sur-Seine, 92200

  • Study site

    Paris, 75010

  • Study site

    Paris, 75231

  • Study site

    Paris, 75908

  • Study site

    Rouen, 76038

  • Study site

    Saint-Cloud, 92210

  • Study site

    Senlis, 60309

  • Study site

    Strasbourg, 67010

  • Study site

    Toulon, 83056

  • Study site

    Tours, 37044

Other trials in France

Australia23 sites

  • Study site

    Brisbane, 4006

  • Study site

    Brisbane, 4104

  • Study site

    Camperdown, 2050

  • Study site

    East Bentleigh, VIC 3165

  • Study site

    Fitzroy, 3065

  • Study site

    Geelong, 3220

  • Study site

    Heidelberg, 3084

  • Study site

    Kurralta Park, 5035

  • Study site

    Malvern, 3144

  • Study site

    Nambour, 4560

  • Study site

    Parkville, 3052

  • Study site

    Perth, 6000

  • Study site

    Perth, 6008

  • Study site

    Port Macquarie, 2444

  • Study site

    St Leonards, 2065

  • Study site

    Sydney, 2031

  • Study site

    Sydney, 2060

  • Study site

    Sydney, 2065

  • Study site

    Sydney, 2139

  • Study site

    Wahroonga, 2076

  • Study site

    Waratah, 2298

  • Study site

    Wodonga, 3690

  • Study site

    Wollongong, 2500

Other trials in Australia

Canada23 sites

  • Study site

    Edmonton, Alberta, T6G 1Z2

  • Study site

    Greater Sudbury, Ontario, P3E 5J1

  • Study site

    Greenfield Park, Quebec, J4V 2H1

  • Study site

    Halifax, Nova Scotia, B3H 2Y9

  • Study site

    Kingston, Ontario, K7L 5P9

  • Study site

    Kitchener, Ontario, N2G 1G3

  • Study site

    London, Ontario, N6A 4L6

  • Study site

    Mississauga, Ontario, L5M 2N1

  • Study site

    Moncton, New Brunswick, E1C 6Z8

  • Study site

    Montreal, Quebec, H1T 2M4

  • Study site

    Montreal, Quebec, H2W 1S6

  • Study site

    Oshawa, Ontario, L1G 2B9

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Québec, Quebec, G1S 4L8

  • Study site

    Saskatoon, Saskatchewan, S7N 4H4

  • Study site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Study site

    Surrey, British Columbia, V3V 1Z2

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Toronto, Ontario, M5G 2M9

  • Study site

    Toronto, Ontario, M9N 1N8

  • Study site

    Vancouver, British Columbia, V5Z 4E6

  • Study site

    Windsor, Ontario, N8W 2X3

  • Study site

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Spain20 sites

  • Study site

    Barcelona, 08003

  • Study site

    Barcelona, 08035

  • Study site

    Burgos, 09005

  • Study site

    Gijón, 33394

  • Study site

    Girona, 17007

  • Study site

    Madrid, 28033

  • Study site

    Madrid, 28034

  • Study site

    Madrid, 28041

  • Study site

    Madrid, 28046

  • Study site

    Madrid, 28222

  • Study site

    Málaga, 29010

  • Study site

    Mataró, 08304

  • Study site

    Navarra, 31008

  • Study site

    Palma de Mallorca, 07014

  • Study site

    Pontevedra, 36002

  • Study site

    San Cristóbal de La Laguna, 38320

  • Study site

    Terrassa, 08221

  • Study site

    Valencia, 41014

  • Study site

    Valencia, 46017

  • Study site

    Zaragoza, 50009

Other trials in Spain

China14 sites

  • Study site

    Beijing, 100021

  • Study site

    Beijing, 100032

  • Study site

    Beijing, 100071

  • Study site

    Beijing, 100853

  • Study site

    Changchun, 130012

  • Study site

    Chengdu, 610041

  • Study site

    Fuzhou, 350025

  • Study site

    Guangzhou, 510060

  • Study site

    Hangzhou, 310022

  • Study site

    Shanghai, 200032

  • Study site

    Suzhou, 215006

  • Study site

    Tianjin, 300060

  • Study site

    Wuhan, 430030

  • Study site

    Zhejiang, 310003

Other trials in China

Russia14 sites

  • Study site

    Chelyabinsk, 454 087

  • Study site

    Ivanovo, 153040

  • Study site

    Kazan', 420029

  • Study site

    Kazan', 420111

  • Study site

    Moscow, 115478

  • Study site

    Moscow, 117837

  • Study site

    Moscow, 121356

  • Study site

    Obninsk, 249036

  • Study site

    Persochnysaint-petersburg, 197758

  • Study site

    Ryazan, 390011

  • Study site

    Saint Petersburg

  • Study site

    Samara, 443066

  • Study site

    Ufa, 450054

  • Study site

    Yekaterinburg, 620905

Other trials in Russia

Brazil13 sites

  • Study site

    Goiânia, 74075-040

  • Study site

    Ijuí, 98700-000

  • Study site

    Jaú, 17210-120

  • Study site

    Porto Alegre, 90035-903

  • Study site

    Porto Alegre, 90430-090

  • Study site

    Porto Alegre, 91350-200

  • Study site

    Rio de Janeiro, 22260-020

  • Study site

    Santo André, 09060-870

  • Study site

    São Paulo, 01209-010

  • Study site

    São Paulo, 01317-000

  • Study site

    São Paulo, 05403

  • Study site

    São Paulo, 1401000

  • Study site

    Sorocaba, 18030-245

Other trials in Brazil

Austria12 sites

  • Study site

    Bludesch, 6712

  • Study site

    Graz, 8036

  • Study site

    Innsbruck, 6020

  • Study site

    Krems, 4560

  • Study site

    Leoben, 8700

  • Study site

    Linz, 4020

  • Study site

    Salzburg, 5020

  • Study site

    Vienna, 1090

  • Study site

    Vienna, 1130

  • Study site

    Wels, 4600

  • Study site

    Wiener Neustadt, 2700

  • Study site

    Wolfsberg, 9400

Other trials in Austria

Japan10 sites

  • Study site

    Aichi, 464-8681

  • Study site

    Ehime, 791-0280

  • Study site

    Fukuoka, 811-1395

  • Study site

    Kyoto, 606-8507

  • Study site

    Osaka, 540-0006

  • Study site

    Saitama, 350-1298

  • Study site

    Tokyo, 104-0045

  • Study site

    Tokyo, 104-8560

  • Study site

    Tokyo, 113-8677

  • Study site

    Tokyo, 135-8550

Other trials in Japan

Taiwan8 sites

  • Study site

    Changhua, 500

  • Study site

    Kaohsiung City, 807

  • Study site

    Kaohsiung City, 813

  • Study site

    Tainan, 704

  • Study site

    Taipei, 100

  • Study site

    Taipei, 112

  • Study site

    Taipei, 114

  • Study site

    Taoyuan, 333

Other trials in Taiwan

Belgium7 sites

  • Study site

    Baudour, 7331

  • Study site

    Brussels, 1090

  • Study site

    Hasselt, 3500

  • Study site

    Namur, 5000

  • Study site

    Sint-Niklaas, 9100

  • Study site

    Tournai, 7500

  • Study site

    Wilrijk, 2610

Other trials in Belgium

Israel7 sites

  • Study site

    Haifa, 31096

  • Study site

    Jerusalem, 91120

  • Study site

    Kfar Saba, 44281

  • Study site

    Petah Tikva, 49100

  • Study site

    Ramat Gan, 52621

  • Study site

    Rehovot, 76100

  • Study site

    Tel Aviv, 64239

Other trials in Israel

Poland7 sites

  • Study site

    Elblag, 82-300

  • Study site

    Lodz, 93-509

  • Study site

    Lublin, 20-081

  • Study site

    Lublin, 20-090

  • Study site

    Poznan, 61-878

  • Study site

    Warsaw, 02-781

  • Study site

    Warsaw, 61485

Other trials in Poland

Switzerland7 sites

  • Study site

    Aarau, 5001

  • Study site

    Basel, 4031

  • Study site

    Bern, 3010

  • Study site

    Chur, 7000

  • Study site

    Thun, 3600

  • Study site

    Winterthur, 8401

  • Study site

    Zurich, 8008

Other trials in Switzerland

South Africa6 sites

  • Study site

    Bloemfontein, 9301

  • Study site

    Durban, 4001

  • Study site

    Johannesburg, 2196

  • Study site

    Pietermaritzburg, 3201

  • Study site

    Pretoria, 0002

  • Study site

    Pretoria, 0181

Other trials in South Africa

Sweden6 sites

  • Study site

    Eskilstuna, 63188

  • Study site

    Gävle, 80187

  • Study site

    Lund, 22185

  • Study site

    Malmö, 20502

  • Study site

    Umeå, 90185

  • Study site

    Uppsala, 751 85

Other trials in Sweden

Czechia5 sites

  • Study site

    Brno, 656 53

  • Study site

    Nový Jičín, 741 01

  • Study site

    Olomouc, 775 20

  • Study site

    Pardubice, 532 03

  • Study site

    Prague, 150 06

Other trials in Czechia

South Korea5 sites

  • Study site

    Kyunggi-do, 411-769

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 135-170

  • Study site

    Seoul, 137-702

  • Study site

    Seoul, 138-736

Other trials in South Korea

Malaysia4 sites

  • Study site

    George Town, 11200

  • Study site

    Kelantan

  • Study site

    Kuala Selangor, 47500

  • Study site

    Petaling Jaya, Selangor, 46050

Other trials in Malaysia

Netherlands4 sites

  • Study site

    Delftzijl, 9934 JD

  • Study site

    Den Helder, 1782GZ

  • Study site

    Groningen, 9713 GZ

  • Study site

    Tilburg, 5042 AD

Other trials in Netherlands

Thailand4 sites

  • Study site

    Bangkok, 10400

  • Study site

    Bangkok, 10700

  • Study site

    Chiang Mai, 50200

  • Study site

    Songkhla, 90110

Other trials in Thailand

Greece3 sites

  • Study site

    Heraklion, 71110

  • Study site

    Pátrai, 26500

  • Study site

    Thessaloniki, 56429

Other trials in Greece

Portugal3 sites

  • Study site

    Coimbra, 3000-075

  • Study site

    Lisbon, 1099-023

  • Study site

    Lisbon, 1649-035

Other trials in Portugal

Argentina2 sites

  • Study site

    Buenos Aires, C1405DCS

  • Study site

    Rosario, S2002KDS

Other trials in Argentina

Finland2 sites

  • Study site

    Tampere, 33520

  • Study site

    Turku, 20521

Other trials in Finland

Hong Kong2 sites

  • Study site

    Hong Kong, 852

  • Study site

    Hong Kong

Other trials in Hong Kong

Mexico2 sites

  • Study site

    León, 37000

  • Study site

    Monterrey, 64020

Other trials in Mexico

New Zealand2 sites

  • Study site

    Auckland

  • Study site

    Wellington, 6002

Other trials in New Zealand

Philippines2 sites

  • Study site

    Cebu, 6000

  • Study site

    Quezon City, 1114

Other trials in Philippines

Romania2 sites

  • Study site

    Bucharest, 022328

  • Study site

    Cluj-Napoca, 400015

Other trials in Romania

Serbia2 sites

  • Study site

    Belgrade, 11000

  • Study site

    Kamenitz, 21204

Other trials in Serbia

Singapore2 sites

  • Study site

    Singapore, 119228

  • Study site

    Singapore, 169610

Other trials in Singapore

Bosnia and Herzegovina1 site

  • Study site

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Costa Rica1 site

  • Study site

    San José, 10103

Other trials in Costa Rica

North Macedonia1 site

  • Study site

    Skopje, 1000

Other trials in North Macedonia

Peru1 site

  • Study site

    Lima, 11

Other trials in Peru

About this study

Official title: An International Multi-centre Open-label 2-arm Phase III Trial of Adjuvant Bevacizumab in "Triple Negative" Breast Cancer.

The main objective of the trial is to compare Invasive Disease-Free Survival (IDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy with 1 year of bevacizumab.

The secondary objectives of this trial are to:

Read more
  • compare Overall Survival (OS), Breast Cancer-Free Interval (BCFI), Disease- Free Survival (DFS) and Distant Disease-Free Survival (DDFS) of patients randomised to treatment with adjuvant chemotherapy alone or to adjuvant chemotherapy in combination with 1 year of bevacizumab
  • evaluate the safety and tolerability of bevacizumab

An exploratory sub-study (not reported here) was to identify biomarkers (from tumour or serum) predictive of toxicity and for the level of benefit from the addition of bevacizumab to standard adjuvant systemic treatment.

Conditions
Breast Cancer
Being tested
Bevacizumab, Standard adjuvant 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.

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab was administered at a dose equivalent of 5 mg/kg/week using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy regimen selected for an individual patient.

  • Standard adjuvant chemotherapyDrug

    All chemotherapy schedules and doses for each patient were prescribed according to the labeled indication of the country in which the patient was receiving therapy.

Study groups in NCT00528567
Study groupRoleWhat they receive
Bevacizumab and ChemotherapyExperimentalParticipants randomized to receive bevacizumab in combination with chemotherapy as prescribed.
Receives: Drug: Bevacizumab; Drug: Standard adjuvant chemotherapy
ChemotherapyActive comparatorParticipants randomized to receive standard adjuvant chemotherapy as prescribed.
Receives: Drug: Standard adjuvant chemotherapy

What is being measured

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

  1. Time to Invasive Disease-free Survival (IDFS) Event

    IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer.

    Measured: Event driven (until data cutoff: 29 February 2012: up to 49 months)

  2. Percentage of Participants With Invasive Disease-free Survival (IDFS) Events

    IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site);Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer or Second primary non-breast invasive cancer. The percentage of participants with and without IDFS Events by the time of the data cutoff is presented.

    Measured: Event driven (until data cutoff: 29 February 2012 up to 49 months)

  3. Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer

    IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer.

    Measured: Event driven (until data cutoff: 29 February 2012: up to 49 months)

  4. Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer

    IDFS, was a composite endpoint defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer. Percentage of participants with and without IDFS Events by the time of data cutoff is presented.

    Measured: Event driven (until data cutoff: 29 February 2012: up to 49 months)

Secondary outcomes (11)

  1. Time to Overall Survival (OS) Event

    OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.

    Measured: Event driven (until data cutoff: 29 February 2012: up to 49 months)

  2. Time to Overall Survival (OS) Event

    OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.

    Measured: Event driven (until data cutoff: 30 June 2014: up to 77 months)

  3. Percentage of Participants With Overall Survival (OS) Event

    OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.

    Measured: Event driven (until data cut off: 29 February 2012: up to 49 months)

  4. Percentage of Participants With Overall Survival (OS) Event

    OS was defined as the time from randomization to death attributable to any cause. Patients for whom no death is captured in the clinical database up to the clinical cut-off date are censored at the last time they were known to be alive.

    Measured: Event driven (until data cut off: 30 June 2014: up to 77 months)

  5. Time to Breast Cancer-Free Interval (BCFI) Event

    BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral Ductal carcinoma in situ or Death only from breast cancer cause.

    Measured: Event driven (until data cutoff: 29 February 2012: up to 49 months)

  6. Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events

    BCFI is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral local/regional invasive breast cancer recurrence or distant breast cancer recurrence; Contralateral invasive breast cancer; Ipsilateral or contralateral DCIS or Death only from breast cancer cause. Percentage of participants with and without BCFI events by the time of the data cutoff is presented.

    Measured: Event driven (until data cutoff: 29 February 2012: up to 49 months)

  7. Time to Disease-Free Survival (DFS) Event

    DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS).

    Measured: Event driven (until data cutoff: 29 February 2012: up to 49 months)

  8. Percentage of Participants With Disease-Free Survival (DFS) Events

    DFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Ipsilateral invasive breast cancer recurrence (same breast); Ipsilateral (same side of body) local regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and/or skin); Distant recurrence (evidence of breast cancer in any anatomic site); Death attributable to any cause; Contralateral (opposite side of the body) invasive breast cancer, Second primary non-breast invasive cancer or New diagnosis of an ipsilateral or contralateral Ductal carcinoma in situ (DCIS). Percentage of Participants with and without DFI Events by the time of the data cut-off is presented.

    Measured: Event driven (until data cutoff: 29 February 2012: up to 49 months)

  9. Time to Distant Disease-Free Survival (DDFS) Event

    DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers).

    Measured: Event driven (until data cutoff: 29 February 2012: up to 49 months)

  10. Percentage of Participants With Distant Disease-Free Survival (DDFS) Events

    DDFS is defined as the time from randomization until the date of the first occurrence of one of the following events: Distant recurrence; Death attributable to any cause; Second primary non-breast invasive cancer (with the exception of non-melanoma Skin cancers). Percentage of participants with and without DDFS Events by the time of the data cutoff is presented.

    Measured: Event driven (until data cutoff: 29 February 2012: up to 49 months)

  11. Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths

    An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.

    A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is Life-Threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.

    Measured: Through end of study: 30 June 2014: up to 77 months

Timeline

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

  1. First posted12 Sep 2007 (estimated)
  2. Study startDec 2007
  3. Primary completionFeb 2012
  4. Study completionJun 2014

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,591 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00528567
Sponsor's protocol ID
BO20289
Other IDs
2007-001128-11
Status last verified
Aug 2015
First submitted
11 Sep 2007
Last updated
4 Sep 2015

Publications

  • Bell R, Brown J, Parmar M, Toi M, Suter T, Steger GG, Pivot X, Mackey J, Jackisch C, Dent R, Hall P, Xu N, Morales L, Provencher L, Hegg R, Vanlemmens L, Kirsch A, Schneeweiss A, Masuda N, Overkamp F, Cameron D. Final efficacy and updated safety results of the randomized phase III BEATRICE trial evaluating adjuvant bevacizumab-containing therapy in triple-negative early breast cancer. Ann Oncol. 2017 Apr 1;28(4):754-760. doi: 10.1093/annonc/mdw665.

    PubMed 27993816

  • Cameron D, Brown J, Dent R, Jackisch C, Mackey J, Pivot X, Steger GG, Suter TM, Toi M, Parmar M, Laeufle R, Im YH, Romieu G, Harvey V, Lipatov O, Pienkowski T, Cottu P, Chan A, Im SA, Hall PS, Bubuteishvili-Pacaud L, Henschel V, Deurloo RJ, Pallaud C, Bell R. Adjuvant bevacizumab-containing therapy in triple-negative breast cancer (BEATRICE): primary results of a randomised, phase 3 trial. Lancet Oncol. 2013 Sep;14(10):933-42. doi: 10.1016/S1470-2045(13)70335-8. Epub 2013 Aug 7.

    PubMed 23932548

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Bevacizumab and Standard adjuvant chemotherapy in people with Breast Cancer, run by Hoffmann-La Roche at 403 sites in 40 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 4 inclusion and 3 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 4 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 403 sites in United States, Germany, Italy, United Kingdom, France and 35 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 10 Sep 2013). 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?

Time to Invasive Disease-free Survival (IDFS) Event (time frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)). The study lists 4 primary outcomes in all. 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 NCT00528567, 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 4 Sep 2015.

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