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

December 21, 2015 updated by: Hoffmann-La Roche

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Five participants randomized to the docetaxel 100 mg/m^2 plus placebo group actually received docetaxel 100 mg/m^2 plus bevacizumab 7.5 mg/kg and are included in the docetaxel 100 mg/m^2 plus bevacizumab 7.5 mg/kg group for the adverse event results. Sixteen participants randomized to the docetaxel 100 mg/m^2 plus placebo group actually received docetaxel 100 mg/m^2 plus bevacizumab 15.0 mg/kg and are included in the docetaxel 100 mg/m^2 plus bevacizumab 15.0 mg/kg group for the adverse event results.

Study Type

Interventional

Enrollment (Actual)

736

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

  • Australia
    • New South Wales
      • Adelaide, New South Wales, Australia, 5011
      • Camperdown, New South Wales, Australia, 2050
      • Westmead, New South Wales, Australia, 2145
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
    • Victoria
      • Box Hill, Victoria, Australia, 3128
      • Fitzroy, Victoria, Australia, 3065
      • Ringwood East, Victoria, Australia, 3135
    • 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
    • GO
      • Goiania, GO, Brazil, 74605-070
    • MG
      • Belo Horizonte, MG, Brazil, 31190-131
    • RS
      • Porto Alegre, RS, Brazil, 90610-000
    • SC
      • Florianopolis, SC, Brazil, 88034-000
    • SP
      • Barretos, SP, Brazil, 14784-400
      • Sao Paulo, SP, Brazil, 01509-010
  • Canada
      • Quebec, Canada, G1S 4L8
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
      • Edmonton, Alberta, Canada, T6G 1Z2
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
      • Sudbury, Ontario, Canada, P3E 5J1
      • Toronto, Ontario, Canada, M4N 3M5
    • Quebec
      • Montreal, Quebec, Canada, H4J 1C5
  • 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
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
      • Modena, Emilia-Romagna, Italy, 41100
      • Parma, Emilia-Romagna, Italy, 43100
    • Friuli-Venezia Giulia
      • Trieste, Friuli-Venezia Giulia, Italy, 34100
      • Udine, Friuli-Venezia Giulia, Italy, 33100
    • Lombardia
      • Treviglio, Lombardia, Italy, 24047
    • Marche
      • Macerata, Marche, Italy, 62100
    • Piemonte
      • Biella, Piemonte, Italy, 13900
    • Sicilia
      • Taormina, Sicilia, Italy, 98030
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
      • Seoul, Korea, Republic of, 120-752
      • Seoul, Korea, Republic of, 135-710
  • 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, 08036
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08907
      • 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, 10400
      • Bangkok, Thailand, 10700
      • 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

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

Female

Description

Inclusion criteria:

  • 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.

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.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Docetaxel 100 mg/m^2 plus placebo
Participants 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.
Drug: Docetaxel
Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.
Drug: Placebo to bevacizumab
Placebo to bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
Experimental: Docetaxel 100 mg/m^2 plus bevacizumab 7.5 mg/kg
Participants 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.
Drug: Docetaxel
Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.
Drug: Bevacizumab
Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
Other Names:
  • Avastin
Experimental: Docetaxel 100 mg/m^2 plus bevacizumab 15.0 mg/kg
Participants 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.
Drug: Docetaxel
Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.
Drug: Bevacizumab
Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
Other Names:
  • Avastin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival
Time Frame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Complete Response or a Partial Response
Time Frame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)
Responses were evaluated using the Response Evaluation Criteria in Solid Tumors. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.
Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)
Duration of Response
Time Frame: Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)
Duration of response was defined as the time from the first documented complete response or partial response to disease progression or death. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Responses were evaluated using the Response Evaluation Criteria in Solid Tumors.
Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)
Time to Treatment Failure
Time Frame: Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)
Time to treatment failure was defined as time from randomization to the date of disease progression, death, or withdrawal of treatment due to an adverse event, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first.
Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)
Overall Survival
Time Frame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)
Overall survival was defined as the time from randomization to death from any cause.
Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

March 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

June 5, 2006

First Submitted That Met QC Criteria

June 5, 2006

First Posted (Estimate)

June 6, 2006

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

December 21, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BO17708
  • 2005-003862-40 (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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