A Study of Avastin (Bevacizumab) in Women With HER2 Negative Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00333775
First received: June 5, 2006
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

This study will evaluate the efficacy and safety of 2 doses of Avastin in combin ation with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy bu t who have not received prior chemotherapy for metastatic disease. The anticipat ed time on treatment is 1-2 years and the target sample size is 500+ individuals


Condition Intervention Phase
Breast Cancer
Drug: bevacizumab [Avastin]
Drug: Docetaxel
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double Blind, Placebo Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Bevacizumab in Combination With Docetaxel in Comparison With Docetaxel Plus Placebo, as First Line Treatment for Patients With HER2 Negative Metastatic and Locally Recurrent Breast Cancer.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best overall response, duration of response, time to treatment failure, overall survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, FACT-B, QoL instrument, medical resource utilization [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 735
Study Start Date: March 2006
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
7.5 mg/kg iv on day 1 of eah 3 week cycle
Drug: Docetaxel
100mg/m2 iv on day 1 of each 3 week cycle
Experimental: 2 Drug: bevacizumab [Avastin]
15mg/kg iv on day 1 of each 3 week cycle
Drug: Docetaxel
100mg/m2 iv on day 1 of each 3 week cycle
Placebo Comparator: 3 Drug: Docetaxel
100mg/m2 iv on day 1 of each 3 week cycle
Drug: Placebo
iv on day 1 of each 3 week cycle

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female patients >= 18 years of age;
  • HER2 negative cancer of the breast with locally recurrent or metastatic disease, suitable for chemotherapy;
  • no adjuvant chemotherapy within 6 months before randomization, and no taxane-based chemotherapy within 12 months before randomization;
  • ECOG performance status 0-1.

Exclusion Criteria:

  • previous chemotherapy for metastatic or locally recurrent breast cancer;
  • radiotherapy for treatment of metastatic disease;
  • other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix;
  • spinal cord compression or brain metastases;
  • major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization;
  • inadequate bone marrow, liver or renal function;
  • uncontrolled hypertension.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333775

  Hide Study Locations
Locations
Australia, New South Wales
Adelaide, New South Wales, Australia, 5011
Camperdown, New South Wales, Australia, 2050
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Auchenflower, Queensland, Australia, 4066
Australia, Victoria
Box Hill, Victoria, Australia, 3128
Fitzroy, Victoria, Australia, 3065
Ringwood East, Victoria, Australia, 3135
Australia, Western Australia
Perth, Western Australia, Australia, 6000
Austria
Graz, Austria, 8036
Salzburg, Austria, 5020
Vöcklabruck, Austria, 4840
Wien, Austria, 1090
Belgium
Bruxelles, Belgium, 1000
Wilrijk, Belgium, 2610
Brazil
Goiania, GO, Brazil, 74605-070
Belo Horizonte, MG, Brazil, 31190-131
Porto Alegre, RS, Brazil, 90610-000
Florianopolis, SC, Brazil, 88034-000
Barretos, SP, Brazil, 14784-400
Sao Paulo, SP, Brazil, 01509-010
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N2
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Ottawa, Ontario, Canada, K1H 8L6
Sudbury, Ontario, Canada, P3E 5J1
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Montreal, Quebec, Canada, H4J 1C5
Canada
Quebec, Canada, G1S 4L8
China
Beijing, China, 100021
France
Besancon, France, 25030
Bordeaux, France, 33076
Caen, France, 14076
Clermont Ferrand, France, 63011
Dijon, France, 21079
Lille, France, 59020
Montpellier, France, 34298
Villejuif, France, 94805
Germany
Ansbach, Germany, 91522
Berlin, Germany, 14195
Düsseldorf, Germany, 40225
Erlangen, Germany, 91054
Frankfurt, Germany, 60596
Frankfurt am Main, Germany, 60389
Halle, Germany, 06120
Hamburg, Germany, 20246
Heidelberg, Germany, 69120
Jena, Germany, 07743
Lemgo, Germany, 32657
München, Germany, 81675
Stuttgart, Germany, 70376
Trier, Germany, 54290
Tübingen, Germany, 72076
Ulm, Germany, 89075
Italy
Bologna, Emilia-Romagna, Italy, 40138
Modena, Emilia-Romagna, Italy, 41100
Parma, Emilia-Romagna, Italy, 43100
Trieste, Friuli-Venezia Giulia, Italy, 34100
Udine, Friuli-Venezia Giulia, Italy, 33100
Treviglio, Lombardia, Italy, 24047
Macerata, Marche, Italy, 62100
Biella, Piemonte, Italy, 13900
Taormina, Sicilia, Italy, 98030
Korea, Republic of
Seoul, Korea, Republic of, 138-736
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 120-752
Lithuania
Kaunas, Lithuania, 50009
Vilnius, Lithuania, 08660
Mexico
Merida, Mexico, 97500
Mexicali, Mexico, 21100
Mexico City, Mexico, 06760
Monterrey, Mexico, 64380
Obregon, Mexico, 85000
Puebla, Mexico, 72530
Netherlands
Sittard, Netherlands, 6131 BK
Utrecht, Netherlands, 3582 KE
Panama
Panama City, Panama, 83-0669
Poland
Krakow, Poland, 31-826
Olsztyn, Poland, 10-513
Poznan, Poland, 60-569
Warszawa, Poland, 02-781
Wroclaw, Poland, 53-413
Portugal
Coimbra, Portugal, 3000-075
Lisboa, Portugal, 1099-023
Romania
Bucuresti, Romania, 022328
South Africa
Pretoria, South Africa, 0002
Sandton, South Africa, 2196
Spain
Barcelona, Spain, 08907
Barcelona, Spain, 08035
Barcelona, Spain, 08036
Barcelona, Spain, 08003
Jaen, Spain, 23007
Madrid, Spain, 28041
Malaga, Spain, 29010
Sweden
Linkoeping, Sweden, 58185
Lund, Sweden, 22185
Umea, Sweden, 90185
Switzerland
Chur, Switzerland, 7000
Taiwan
Kaohsiung, Taiwan, 813
Taipei, Taiwan, 100
Taipei, Taiwan, 114
Thailand
Bangkok, Thailand, 10700
Bangkok, Thailand, 10400
Khon Kaen, Thailand, 40002
United Kingdom
Bournemouth, United Kingdom, BH7 7DW
Cambridge, United Kingdom, CB2 2QQ
Edinburgh, United Kingdom, EH4 2XU
Leeds, United Kingdom, LS9 7TF
Leeds, United Kingdom, LS16 5WW
London, United Kingdom, SE1 7EH
Manchester, United Kingdom, M20 4BX
Middlesex, United Kingdom, HA6 2RN
Newcastle Upon Tyne, United Kingdom, NE7 7DN
Truro, United Kingdom, TR1 3LJ
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00333775     History of Changes
Other Study ID Numbers: BO17708, 2005-003862-40
Study First Received: June 5, 2006
Last Updated: October 13, 2014
Health Authority: France: AFSSAPS (Agence francaise de securite sanitaire des produits de Sante)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Docetaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014