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

August 5, 2015 updated by: Hoffmann-La Roche

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:

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2591

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1405DCS
      • Rosario, Argentina, S2002KDS
  • Australia
      • Brisbane, Australia, 4006
      • Brisbane, Australia, 4104
      • Camperdown, Australia, 2050
      • East Bentleigh, Australia, VIC 3165
      • Fitzroy, Australia, 3065
      • Geelong, Australia, 3220
      • Heidelberg, Australia, 3084
      • Kurralta Park, Australia, 5035
      • Malvern, Australia, 3144
      • Nambour, Australia, 4560
      • Parkville, Australia, 3052
      • Perth, Australia, 6000
      • Perth, Australia, 6008
      • Port Macquarie, Australia, 2444
      • St. Leonards, Australia, 2065
      • Sydney, Australia, 2031
      • Sydney, Australia, 2060
      • Sydney, Australia, 2139
      • Sydney, Australia, 2065
      • Wahroonga, Australia, 2076
      • Waratah, Australia, 2298
      • Wodonga, Australia, 3690
      • Wollongong, Australia, 2500
  • Austria
      • Bludesch, Austria, 6712
      • Graz, Austria, 8036
      • Innsbruck, Austria, 6020
      • Krems, Austria, 4560
      • Leoben, Austria, 8700
      • Linz, Austria, 4020
      • Salzburg, Austria, 5020
      • Wels, Austria, 4600
      • Wien, Austria, 1130
      • Wien, Austria, 1090
      • Wiener Neustadt, Austria, 2700
      • Wolfsberg, Austria, 9400
  • Belgium
      • Baudour, Belgium, 7331
      • Bruxelles, Belgium, 1090
      • Hasselt, Belgium, 3500
      • Namur, Belgium, 5000
      • Sint-niklaas, Belgium, 9100
      • Tournai, Belgium, 7500
      • Wilrijk, Belgium, 2610
  • Bosnia and Herzegovina
      • Sarajevo, Bosnia and Herzegovina, 71000
  • Brazil
      • Goiania, Brazil, 74075-040
      • Ijui, Brazil, 98700-000
      • JAU, Brazil, 17210-120
      • Porto Alegre, Brazil, 90035-903
      • Porto Alegre, Brazil, 91350-200
      • Porto Alegre, Brazil, 90430-090
      • Rio de Janeiro, Brazil, 22260-020
      • Santo Andre, Brazil, 09060-870
      • Sao Paulo, Brazil, 01209-010
      • Sao Paulo, Brazil, 01317-000
      • Sao Paulo, Brazil, 05403
      • Sao Paulo, Brazil, 1401000
      • Sorocaba, Brazil, 18030-245
  • Canada
      • Quebec, Canada, G1S 4L8
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1Z2
      • Vancouver, British Columbia, Canada, V5Z 4E6
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 6Z8
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
    • Ontario
      • Kingston, Ontario, Canada, K7L 5P9
      • Kitchener, Ontario, Canada, N2G 1G3
      • London, Ontario, Canada, N6A 4L6
      • Mississauga, Ontario, Canada, L5M 2N1
      • Oshawa, Ontario, Canada, L1G 2B9
      • Ottawa, Ontario, Canada, K1H 8L6
      • Sudbury, Ontario, Canada, P3E 5J1
      • Toronto, Ontario, Canada, M5G 2M9
      • Toronto, Ontario, Canada, M4N 3M5
      • Toronto, Ontario, Canada, M9N 1N8
      • Windsor, Ontario, Canada, N8W 2X3
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
      • Montreal, Quebec, Canada, H1T 2M4
      • Montreal, Quebec, Canada, H2W 1S6
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
  • China
      • Beijing, China, 100021
      • Beijing, China, 100071
      • Beijing, China, 100853
      • Beijing, China, 100032
      • Changchun, China, 130012
      • Chengdu, China, 610041
      • Fuzhou, China, 350025
      • Guangzhou, China, 510060
      • Hang Zhou, China, 310022
      • Shanghai, China, 200032
      • Suzhou, China, 215006
      • Tianjin, China, 300060
      • Wuhan, China, 430030
      • Zhejiang, China, 310003
  • Costa Rica
      • San Jose, Costa Rica, 10103
  • Czech Republic
      • Brno, Czech Republic, 656 53
      • Novy Jicin, Czech Republic, 741 01
      • Olomouc, Czech Republic, 775 20
      • Pardubice, Czech Republic, 532 03
      • Praha, Czech Republic, 150 06
  • Finland
      • Tampere, Finland, 33520
      • Turku, Finland, 20521
  • France
      • Angers, France, 49933
      • Bayonne, France, 64100
      • Besancon, France, 25030
      • Bobigny, France, 93009
      • Bordeaux, France, 33077
      • Brest, France, 29609
      • Clermont Ferrand, France, 63050
      • Colmar, France, 68024
      • Grenoble, France, 38100
      • La Chaussee St Victor, France, 41260
      • Le Mans, France, 72000
      • Lille, France, 59020
      • Lille, France, 59000
      • Limoges, France, 87039
      • Marseille, France, 13285
      • Montbeliard, France, 25209
      • Montpellier, France, 34298
      • Mougins, France, 6250
      • Nancy, France, 54100
      • Neuilly Sur Seine, France, 92200
      • Paris, France, 75908
      • Paris, France, 75010
      • Paris, France, 75231
      • Rouen, France, 76038
      • Saint-cloud, France, 92210
      • Senlis, France, 60309
      • Strasbourg, France, 67010
      • Toulon, France, 83056
      • Tours, France, 37044
  • Germany
      • Berlin, Germany, 14195
      • Berlin, Germany, 10317
      • Bielefeld, Germany, 33604
      • Bonn, Germany, 53111
      • Chemnitz, Germany, 09116
      • Coburg, Germany, 96450
      • Dortmund, Germany, 44137
      • Dresden, Germany, 01307
      • Düsseldorf, Germany, 40225
      • Frankfurt Am Main, Germany, 60389
      • Freiburg, Germany, 79106
      • Georgsmarienhütte, Germany, 49124
      • Greifswald, Germany, 17475
      • Hamburg, Germany, 20246
      • Hamburg, Germany, 20357
      • Heidelberg, Germany, 69115
      • Herne, Germany, 44625
      • Kassel, Germany, 34117
      • Kiel, Germany, 24105
      • Koeln, Germany, 50924
      • Krefeld, Germany, 47805
      • Leipzig, Germany, 04129
      • Lemgo, Germany, 32657
      • Lüneburg, Germany, 21339
      • Magdeburg, Germany, 39108
      • Marburg, Germany, 35043
      • München, Germany, 81925
      • Münster, Germany, 48149
      • Offenbach, Germany, 63069
      • Offenburg, Germany, 77654
      • Recklinghausen, Germany, 45657
      • Rosenheim, Germany, 83022
      • Stade, Germany, 21680
      • Trier, Germany, 54290
      • Tübingen, Germany, 72076
      • ULM, Germany, 89075
      • WEIßENFELS, Germany, 06667
      • Wiesbaden, Germany, 65199
      • Witten, Germany, 58452
  • Greece
      • Heraklion, Greece, 71110
      • Patras, Greece, 26500
      • Thessaloniki, Greece, 56429
  • Hong Kong
      • Hong Kong, Hong Kong
      • Hong Kong, Hong Kong, 852
  • Israel
      • Haifa, Israel, 31096
      • Jerusalem, Israel, 91120
      • Kfar Saba, Israel, 44281
      • Petach Tikva, Israel, 49100
      • Ramat-gan, Israel, 52621
      • Rehovot, Israel, 76100
      • Tel Aviv, Israel, 64239
  • Italy
      • Aviano, Italy, 33081
      • Bari, Italy, 70126
      • Bergamo, Italy, 24128
      • Brescia, Italy, 25123
      • Brindisi, Italy, 72100
      • Candiolo, Italy, 10060
      • Cattolica, Italy, 47841
      • Cesena, Italy, 47023
      • Fano, Italy, 61032
      • Genova, Italy, 16142
      • Lecce, Italy, 73100
      • Lido Di Camaiore, Italy, 55043
      • Livorno, Italy, 57100
      • Lugo, Italy
      • Mantova, Italy, 46100
      • Noale, Italy, 30033
      • Padova, Italy, 35128
      • Palermo, Italy, 90146
      • Parma, Italy, 43100
      • Pavia, Italy, 27100
      • Potenza, Italy, 85100
      • Ravenna, Italy, 48100
      • Rimini, Italy, 47037
      • Roma, Italy, 00161
      • Roma, Italy, 00144
      • Roma, Italy, 00158
      • Rozzano, Italy, 20089
      • San Giovanni Rotondo, Italy, 71013
      • Sassari, Italy, 07100
      • Taormina, Italy, 98039
      • Treviglio, Italy, 24047
      • Vecchiazzano, Italy, 47100
  • Japan
      • Aichi, Japan, 464-8681
      • Ehime, Japan, 791-0280
      • Fukuoka, Japan, 811-1395
      • Kyoto, Japan, 606-8507
      • Osaka, Japan, 540-0006
      • Saitama, Japan, 350-1298
      • Tokyo, Japan, 113-8677
      • Tokyo, Japan, 135-8550
      • Tokyo, Japan, 104-0045
      • Tokyo, Japan, 104-8560
  • Korea, Republic of
      • Kyunggi-do, Korea, Republic of, 411-769
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 110-744
      • Seoul, Korea, Republic of, 135-170
      • Seoul, Korea, Republic of, 137-702
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
  • Malaysia
      • Kelantan, Malaysia
      • Penang, Malaysia, 11200
      • Petaling Jaya, Selangor, Malaysia, 46050
      • Selangor, Malaysia, 47500
  • Mexico
      • Leon, Mexico, 37000
      • Monterrey, Mexico, 64020
  • Netherlands
      • Delftzijl, Netherlands, 9934 JD
      • Den Helder, Netherlands, 1782GZ
      • Groningen, Netherlands, 9713 GZ
      • Tilburg, Netherlands, 5042 AD
  • New Zealand
      • Auckland, New Zealand
      • Wellington, New Zealand, 6002
  • Peru
      • Lima, Peru, 11
  • Philippines
      • Cebu, Philippines, 6000
      • Quezon City, Philippines, 1114
  • Poland
      • Elblag, Poland, 82-300
      • Lodz, Poland, 93-509
      • Lublin, Poland, 20-090
      • Lublin, Poland, 20-081
      • Poznan, Poland, 61-878
      • Warsaw, Poland, 61485
      • Warszawa, Poland, 02-781
  • Portugal
      • Coimbra, Portugal, 3000-075
      • Lisboa, Portugal, 1649-035
      • Lisboa, Portugal, 1099-023
  • Romania
      • Bucharest, Romania, 022328
      • Cluj Napoca, Romania, 400015
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454 087
      • Ekaterinburg, Russian Federation, 620905
      • Ivanovo, Russian Federation, 153040
      • Kazan, Russian Federation, 420029
      • Kazan, Russian Federation, 420111
      • Moscow, Russian Federation, 115478
      • Moscow, Russian Federation, 121356
      • Moscow, Russian Federation, 117837
      • Obninsk, Russian Federation, 249036
      • Persochnysaint-petersburg, Russian Federation, 197758
      • Ryazan, Russian Federation, 390011
      • Samara, Russian Federation, 443066
      • St Petersburg, Russian Federation
      • UFA, Russian Federation, 450054
  • Serbia
      • Belgrade, Serbia, 11000
      • Sremska Kamenica, Serbia, 21204
  • Singapore
      • Singapore, Singapore, 119228
      • Singapore, Singapore, 169610
  • South Africa
      • Bloemfontein, South Africa, 9301
      • Durban, South Africa, 4001
      • Johannesburg, South Africa, 2196
      • Pietermaritzburg, South Africa, 3201
      • Pretoria, South Africa, 0002
      • Pretoria, South Africa, 0181
  • Spain
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08035
      • Burgos, Spain, 09005
      • Gijon, Spain, 33394
      • Girona, Spain, 17007
      • La Laguna, Spain, 38320
      • Madrid, Spain, 28046
      • Madrid, Spain, 28034
      • Madrid, Spain, 28041
      • Madrid, Spain, 28222
      • Madrid, Spain, 28033
      • Malaga, Spain, 29010
      • Mataro, Spain, 08304
      • Málaga, Spain, 29010
      • Navarra, Spain, 31008
      • Palma de Mallorca, Spain, 07014
      • Pontevedra, Spain, 36002
      • Terrassa, Spain, 08221
      • Valencia, Spain, 46017
      • Valencia, Spain, 41014
      • Zaragoza, Spain, 50009
  • Sweden
      • Eskilstuna, Sweden, 63188
      • Gaevle, Sweden, 80187
      • Lund, Sweden, 22185
      • Malmoe, Sweden, 20502
      • Umea, Sweden, 90185
      • Uppsala, Sweden, 751 85
  • Switzerland
      • Aarau, Switzerland, 5001
      • Basel, Switzerland, 4031
      • Bern, Switzerland, 3010
      • Chur, Switzerland, 7000
      • Thun, Switzerland, 3600
      • Winterthur, Switzerland, 8401
      • Zürich, Switzerland, 8008
  • Taiwan
      • Changhua, Taiwan, 500
      • Kaohsiung, Taiwan, 813
      • Kaohsiung, Taiwan, 807
      • Tainan, Taiwan, 704
      • Taipei, Taiwan, 100
      • Taipei, Taiwan, 114
      • Taipei, Taiwan, 112
      • Taoyuan, Taiwan, 333
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10700
      • Chiang Mai, Thailand, 50200
      • Songkhla, Thailand, 90110
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
      • Birmingham, United Kingdom, B15 2TT
      • Bournemouth, United Kingdom, BH7 7DW
      • Brighton, United Kingdom, BN2 5BE
      • Bristol, United Kingdom, BS2 8ED
      • Cambridge, United Kingdom, CB2 2QQ
      • Cardiff, United Kingdom, CF14 2TL
      • Chelsmford, United Kingdom, CM1 7ET
      • Colchester, United Kingdom, CO3 3NB
      • Dundee, United Kingdom, DD1 9SY
      • Edinburgh, United Kingdom, EH4 2XU
      • Epping, United Kingdom, CM16 6TN
      • Exeter, United Kingdom, EX2 5DW
      • Glasgow, United Kingdom, G12 0YN
      • Guildford, United Kingdom, GU2 5XX
      • Huddersfield, United Kingdom, HD3 3EA
      • Ipswich, United Kingdom, IP4 5PD
      • Leeds, United Kingdom, LS9 7TF
      • London, United Kingdom, SE1 9RT
      • London, United Kingdom, W2 1NY
      • London, United Kingdom, NW3 2QG
      • London, United Kingdom, EC1 A7BE
      • Manchester, United Kingdom, M20 4BX
      • Merseyside, United Kingdom, CH63 45Y
      • Newcastle Upon Tyne, United Kingdom, NE4 6BE
      • Northwood, United Kingdom, HA6 2RN
      • Peterborough, United Kingdom, PE 3 9GZ
      • Sheffield, United Kingdom, S1O 2SJ
      • Southampton, United Kingdom, SO16 6YD
      • Stoke-on-trent, United Kingdom, ST4 7LN
      • Truro, United Kingdom, TR1 3LJ
      • Wolverhampton, United Kingdom, WV10 0QP
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35805
      • Mobile, Alabama, United States, 36604
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
    • California
      • Bakersfield, California, United States, 93309
      • Fountain Valley, California, United States, 92708
      • Greenbrae, California, United States, 94904
      • Los Angeles, California, United States, 90057
      • Pleasant Hill, California, United States, 94523
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
      • Stamford, Connecticut, United States, 06902
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Gainesville, Florida, United States, 32605
      • Orlando, Florida, United States, 32806
      • Tamarac, Florida, United States, 33321
    • Georgia
      • Atlanta, Georgia, United States, 30318
      • Augusta, Georgia, United States, 30901
      • Lawrenceville, Georgia, United States, 30046
    • Illinois
      • Niles, Illinois, United States, 60714
    • Iowa
      • Iowa City, Iowa, United States, 52242
      • Waterloo, Iowa, United States, 50702
    • Maryland
      • Baltimore, Maryland, United States, 21215
      • Baltimore, Maryland, United States, 21237
      • Rockville, Maryland, United States, 20850-3348
    • Michigan
      • Brownstown, Michigan, United States, 48183
      • Kalamazoo, Michigan, United States, 49007
      • Southfield, Michigan, United States, 48075-3707
    • Missouri
      • Kansas City, Missouri, United States, 64111
      • St Louis, Missouri, United States, 63141
    • New Jersey
      • Long Branch, New Jersey, United States, 07740
    • New York
      • Bronx, New York, United States, 10469
    • North Carolina
      • Hickory, North Carolina, United States, 28602
      • Winston-salem, North Carolina, United States, 27103
    • Ohio
      • Cincinnati, Ohio, United States, 45242
      • Columbus, Ohio, United States, 43235
      • Middletown, Ohio, United States, 45042
    • South Carolina
      • Columbia, South Carolina, United States, 29210
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
      • Germantown, Tennessee, United States, 38138
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Austin, Texas, United States, 78759
      • Dallas, Texas, United States, 75234
    • Vermont
      • Rutland, Vermont, United States, 05701
    • Virginia
      • Abingdon, Virginia, United States, 24211
      • Richmond, Virginia, United States, 23230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab and Chemotherapy
Participants randomized to receive bevacizumab in combination with chemotherapy as prescribed.
Drug: Bevacizumab
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.
Other Names:
  • Avastin
Drug: Standard adjuvant chemotherapy
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.
Active Comparator: Chemotherapy
Participants randomized to receive standard adjuvant chemotherapy as prescribed.
Drug: Standard adjuvant chemotherapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Invasive Disease-free Survival (IDFS) Event
Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
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.
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Percentage of Participants With Invasive Disease-free Survival (IDFS) Events
Time Frame: Event driven (until data cutoff: 29 February 2012 up to 49 months)
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.
Event driven (until data cutoff: 29 February 2012 up to 49 months)
Time to Invasive Disease-free Survival (IDFS) Event Excluding Second Primary Non-Breast Invasive Cancer
Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
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.
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Percentage of Participants With Invasive Disease-free Survival (IDFS) Events Excluding Second Primary Non-Breast Invasive Cancer
Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
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.
Event driven (until data cutoff: 29 February 2012: up to 49 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Overall Survival (OS) Event
Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
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.
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Time to Overall Survival (OS) Event
Time Frame: Event driven (until data cutoff: 30 June 2014: up to 77 months)
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.
Event driven (until data cutoff: 30 June 2014: up to 77 months)
Percentage of Participants With Overall Survival (OS) Event
Time Frame: Event driven (until data cut off: 29 February 2012: up to 49 months)
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.
Event driven (until data cut off: 29 February 2012: up to 49 months)
Percentage of Participants With Overall Survival (OS) Event
Time Frame: Event driven (until data cut off: 30 June 2014: up to 77 months)
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.
Event driven (until data cut off: 30 June 2014: up to 77 months)
Time to Breast Cancer-Free Interval (BCFI) Event
Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
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.
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Percentage of Participants With Breast Cancer-Free Interval (BCFI) Events
Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
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.
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Time to Disease-Free Survival (DFS) Event
Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
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).
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Percentage of Participants With Disease-Free Survival (DFS) Events
Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
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.
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Time to Distant Disease-Free Survival (DDFS) Event
Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
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).
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Percentage of Participants With Distant Disease-Free Survival (DDFS) Events
Time Frame: Event driven (until data cutoff: 29 February 2012: up to 49 months)
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.
Event driven (until data cutoff: 29 February 2012: up to 49 months)
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) and Deaths
Time Frame: Through end of study: 30 June 2014: up to 77 months

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

Collaborators and Investigators

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Sponsor

Hoffmann-La Roche

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

September 11, 2007

First Submitted That Met QC Criteria

September 11, 2007

First Posted (Estimate)

September 12, 2007

Study Record Updates

Last Update Posted (Estimate)

September 4, 2015

Last Update Submitted That Met QC Criteria

August 5, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO20289
  • 2007-001128-11 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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