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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
736

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 6, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 27, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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