Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00333775




Registration number
NCT00333775
Ethics application status
Date submitted
5/06/2006
Date registered
6/06/2006
Date last updated
27/01/2016

Titles & IDs
Public title
A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer
Scientific 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.
Secondary ID [1] 0 0
2005-003862-40
Secondary ID [2] 0 0
BO17708
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Docetaxel
Treatment: Drugs - Placebo to bevacizumab
Treatment: Drugs - Bevacizumab

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.

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.

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.


Treatment: Drugs: Docetaxel
Docetaxel was supplied in 2 vials, 1 containing docetaxel and 1 containing a solvent, for intravenous infusion.

Treatment: Drugs: Placebo to bevacizumab
Placebo to bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.

Treatment: Drugs: Bevacizumab
Bevacizumab was supplied as a sterile liquid for intravenous infusion in single-use vials.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival
Timepoint [1] 0 0
Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)
Secondary outcome [1] 0 0
Percentage of Participants With a Complete Response or a Partial Response
Timepoint [1] 0 0
Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)
Secondary outcome [2] 0 0
Duration of Response
Timepoint [2] 0 0
Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)
Secondary outcome [3] 0 0
Time to Treatment Failure
Timepoint [3] 0 0
Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
736
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Camperdown
Recruitment hospital [3] 0 0
- Westmead
Recruitment hospital [4] 0 0
- Auchenflower
Recruitment hospital [5] 0 0
- Box Hill
Recruitment hospital [6] 0 0
- Fitzroy
Recruitment hospital [7] 0 0
- Ringwood East
Recruitment hospital [8] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3065 - Fitzroy
Recruitment postcode(s) [7] 0 0
3135 - Ringwood East
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Salzburg
Country [3] 0 0
Austria
State/province [3] 0 0
Vöcklabruck
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Belgium
State/province [5] 0 0
Bruxelles
Country [6] 0 0
Belgium
State/province [6] 0 0
Wilrijk
Country [7] 0 0
Brazil
State/province [7] 0 0
GO
Country [8] 0 0
Brazil
State/province [8] 0 0
MG
Country [9] 0 0
Brazil
State/province [9] 0 0
RS
Country [10] 0 0
Brazil
State/province [10] 0 0
SC
Country [11] 0 0
Brazil
State/province [11] 0 0
SP
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
British Columbia
Country [14] 0 0
Canada
State/province [14] 0 0
Nova Scotia
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
China
State/province [17] 0 0
Beijing
Country [18] 0 0
France
State/province [18] 0 0
Besancon
Country [19] 0 0
France
State/province [19] 0 0
Bordeaux
Country [20] 0 0
France
State/province [20] 0 0
Caen
Country [21] 0 0
France
State/province [21] 0 0
Clermont Ferrand
Country [22] 0 0
France
State/province [22] 0 0
Dijon
Country [23] 0 0
France
State/province [23] 0 0
Lille
Country [24] 0 0
France
State/province [24] 0 0
Montpellier
Country [25] 0 0
France
State/province [25] 0 0
Villejuif
Country [26] 0 0
Germany
State/province [26] 0 0
Ansbach
Country [27] 0 0
Germany
State/province [27] 0 0
Berlin
Country [28] 0 0
Germany
State/province [28] 0 0
Düsseldorf
Country [29] 0 0
Germany
State/province [29] 0 0
Erlangen
Country [30] 0 0
Germany
State/province [30] 0 0
Frankfurt am Main
Country [31] 0 0
Germany
State/province [31] 0 0
Frankfurt
Country [32] 0 0
Germany
State/province [32] 0 0
Halle
Country [33] 0 0
Germany
State/province [33] 0 0
Hamburg
Country [34] 0 0
Germany
State/province [34] 0 0
Heidelberg
Country [35] 0 0
Germany
State/province [35] 0 0
Jena
Country [36] 0 0
Germany
State/province [36] 0 0
Lemgo
Country [37] 0 0
Germany
State/province [37] 0 0
München
Country [38] 0 0
Germany
State/province [38] 0 0
Stuttgart
Country [39] 0 0
Germany
State/province [39] 0 0
Trier
Country [40] 0 0
Germany
State/province [40] 0 0
Tübingen
Country [41] 0 0
Germany
State/province [41] 0 0
Ulm
Country [42] 0 0
Italy
State/province [42] 0 0
Emilia-Romagna
Country [43] 0 0
Italy
State/province [43] 0 0
Friuli-Venezia Giulia
Country [44] 0 0
Italy
State/province [44] 0 0
Lombardia
Country [45] 0 0
Italy
State/province [45] 0 0
Marche
Country [46] 0 0
Italy
State/province [46] 0 0
Piemonte
Country [47] 0 0
Italy
State/province [47] 0 0
Sicilia
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Seoul
Country [49] 0 0
Lithuania
State/province [49] 0 0
Kaunas
Country [50] 0 0
Lithuania
State/province [50] 0 0
Vilnius
Country [51] 0 0
Mexico
State/province [51] 0 0
Merida
Country [52] 0 0
Mexico
State/province [52] 0 0
Mexicali
Country [53] 0 0
Mexico
State/province [53] 0 0
Mexico City
Country [54] 0 0
Mexico
State/province [54] 0 0
Monterrey
Country [55] 0 0
Mexico
State/province [55] 0 0
Obregon
Country [56] 0 0
Mexico
State/province [56] 0 0
Puebla
Country [57] 0 0
Netherlands
State/province [57] 0 0
Sittard
Country [58] 0 0
Netherlands
State/province [58] 0 0
Utrecht
Country [59] 0 0
Panama
State/province [59] 0 0
Panama City
Country [60] 0 0
Poland
State/province [60] 0 0
Krakow
Country [61] 0 0
Poland
State/province [61] 0 0
Olsztyn
Country [62] 0 0
Poland
State/province [62] 0 0
Poznan
Country [63] 0 0
Poland
State/province [63] 0 0
Warszawa
Country [64] 0 0
Poland
State/province [64] 0 0
Wroclaw
Country [65] 0 0
Portugal
State/province [65] 0 0
Coimbra
Country [66] 0 0
Portugal
State/province [66] 0 0
Lisboa
Country [67] 0 0
Romania
State/province [67] 0 0
Bucuresti
Country [68] 0 0
South Africa
State/province [68] 0 0
Pretoria
Country [69] 0 0
South Africa
State/province [69] 0 0
Sandton
Country [70] 0 0
Spain
State/province [70] 0 0
Barcelona
Country [71] 0 0
Spain
State/province [71] 0 0
Jaen
Country [72] 0 0
Spain
State/province [72] 0 0
Madrid
Country [73] 0 0
Spain
State/province [73] 0 0
Malaga
Country [74] 0 0
Sweden
State/province [74] 0 0
Linkoeping
Country [75] 0 0
Sweden
State/province [75] 0 0
Lund
Country [76] 0 0
Sweden
State/province [76] 0 0
Umea
Country [77] 0 0
Switzerland
State/province [77] 0 0
Chur
Country [78] 0 0
Taiwan
State/province [78] 0 0
Kaohsiung
Country [79] 0 0
Taiwan
State/province [79] 0 0
Taipei
Country [80] 0 0
Thailand
State/province [80] 0 0
Bangkok
Country [81] 0 0
Thailand
State/province [81] 0 0
Khon Kaen
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Bournemouth
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Cambridge
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Edinburgh
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Leeds
Country [86] 0 0
United Kingdom
State/province [86] 0 0
London
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Manchester
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Middlesex
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Newcastle Upon Tyne
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00333775