A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer
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.
2 other identifiers
interventional
736
23 countries
106
Brief Summary
This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Mar 2006
Typical duration for phase_3 breast-cancer
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 5, 2006
CompletedFirst Posted
Study publicly available on registry
June 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
January 27, 2016
CompletedJanuary 27, 2016
December 1, 2015
1.6 years
June 5, 2006
July 22, 2015
December 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
Progression-free survival was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST 1.0). Progression-free survival was defined as the time from randomization to the time of the first documented disease progression or death, whichever occurred first. Disease progression was defined as ≥ 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions, or appearance of new lesion(s).
Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)
Secondary Outcomes (4)
Percentage of Participants With a Complete Response or a Partial Response
Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)
Duration of Response
Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)
Time to Treatment Failure
Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)
Overall Survival
Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)
Study Arms (3)
Docetaxel 100 mg/m^2 plus placebo
EXPERIMENTALParticipants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
Docetaxel 100 mg/m^2 plus bevacizumab 7.5 mg/kg
EXPERIMENTALParticipants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
Docetaxel 100 mg/m^2 plus bevacizumab 15.0 mg/kg
EXPERIMENTALParticipants received docetaxel 100 mg/m\^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
Interventions
Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.
Placebo to bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
Eligibility Criteria
You may qualify if:
- Female patients ≥ 18 years of age.
- Human epidermal growth factor receptor 2 (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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (114)
Unknown Facility
Adelaide, New South Wales, 5011, Australia
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Camperdown, New South Wales, 2050, Australia
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Westmead, New South Wales, 2145, Australia
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Auchenflower, Queensland, 4066, Australia
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Box Hill, Victoria, 3128, Australia
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Fitzroy, Victoria, 3065, Australia
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Ringwood East, Victoria, 3135, Australia
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Perth, Western Australia, 6000, Australia
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Graz, 8036, Austria
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Salzburg, 5020, Austria
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Vienna, 1090, Austria
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Vöcklabruck, 4840, Austria
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Brussels, 1000, Belgium
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Wilrijk, 2610, Belgium
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Goiânia, Goiás, 74605-070, Brazil
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Belo Horizonte, Minas Gerais, 31190-131, Brazil
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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
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Florianópolis, Santa Catarina, 88034-000, Brazil
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Barretos, São Paulo, 14784-400, Brazil
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São Paulo, São Paulo, 01509-010, Brazil
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Calgary, Alberta, T2N 4N2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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Greater Sudbury, Ontario, P3E 5J1, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Québec, Quebec, G1S 4L8, Canada
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Beijing, 100021, China
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Besançon, 25030, France
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Bordeaux, 33076, France
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Caen, 14076, France
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Clermont-Ferrand, 63011, France
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Dijon, 21079, France
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Lille, 59020, France
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Montpellier, 34298, France
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Villejuif, 94805, France
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Ansbach, 91522, Germany
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Berlin, 14195, Germany
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Düsseldorf, 40225, Germany
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Erlangen, 91054, Germany
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Frankfurt, 60596, Germany
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Frankfurt am Main, 60389, Germany
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Halle, 06120, Germany
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Hamburg, 20246, Germany
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Heidelberg, 69120, Germany
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Jena, 07743, Germany
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Lemgo, 32657, Germany
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München, 81675, Germany
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Stuttgart, 70376, Germany
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Trier, 54290, Germany
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Tübingen, 72076, Germany
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Ulm, 89075, Germany
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Bologna, Emilia-Romagna, 40138, Italy
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Modena, Emilia-Romagna, 41100, Italy
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Parma, Emilia-Romagna, 43100, Italy
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Trieste, Friuli Venezia Giulia, 34100, Italy
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Udine, Friuli Venezia Giulia, 33100, Italy
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Treviglio, Lombardy, 24047, Italy
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Biella, Piedmont, 13900, Italy
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Taormina, Sicily, 98030, Italy
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Macerata, The Marches, 62100, Italy
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Kaunas, 50009, Lithuania
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Vilnius, 08660, Lithuania
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Mexicali, 21100, Mexico
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Mexico City, 06760, Mexico
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Mérida, 97500, Mexico
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Monterrey, 64380, Mexico
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Obregón, 85000, Mexico
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Puebla City, 72530, Mexico
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Sittard, 6131 BK, Netherlands
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Utrecht, 3582 KE, Netherlands
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Panama City, 83-0669, Panama
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Krakow, 31-826, Poland
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Olsztyn, 10-513, Poland
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Poznan, 60-569, Poland
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Warsaw, 02-781, Poland
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Wroclaw, 53-413, Poland
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Coimbra, 3000-075, Portugal
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Lisbon, 1099-023, Portugal
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Bucharest, 022328, Romania
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Pretoria, 0002, South Africa
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Sandton, 2196, South Africa
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
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Seoul, 138-736, South Korea
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Barcelona, Barcelona, 08003, Spain
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Barcelona, Barcelona, 08035, Spain
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Barcelona, Barcelona, 08036, Spain
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Barcelona, Barcelona, 08907, Spain
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Jaén, Jaen, 23007, Spain
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Madrid, Madrid, 28041, Spain
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Málaga, Malaga, 29010, Spain
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Linköping, 58185, Sweden
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Lund, 22185, Sweden
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Umeå, 90185, Sweden
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Chur, 7000, Switzerland
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Kaohsiung City, 813, Taiwan
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Taipei, 100, Taiwan
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Taipei, 114, Taiwan
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Khon Kaen, 40002, Thailand
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Bournemouth, BH7 7DW, United Kingdom
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Cambridge, CB2 2QQ, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Leeds, LS16 5WW, United Kingdom
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Leeds, LS9 7TF, United Kingdom
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London, SE1 7EH, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Middlesex, HA6 2RN, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
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Truro, TR1 3LJ, United Kingdom
Related Publications (1)
Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.
PMID: 29522361DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2006
First Posted
June 6, 2006
Study Start
March 1, 2006
Primary Completion
October 1, 2007
Study Completion
October 1, 2013
Last Updated
January 27, 2016
Results First Posted
January 27, 2016
Record last verified: 2015-12