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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
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Austria
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Salzburg
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Austria
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Vöcklabruck
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
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Belgium
State/province [5] 0 0
Bruxelles
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Belgium
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Wilrijk
Country [7] 0 0
Brazil
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GO
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Brazil
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MG
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Brazil
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RS
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Brazil
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SC
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Brazil
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SP
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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China
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Beijing
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France
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Besancon
Country [19] 0 0
France
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Bordeaux
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France
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Caen
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France
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Clermont Ferrand
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France
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Dijon
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France
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Lille
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France
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Montpellier
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France
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Villejuif
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Germany
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Ansbach
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Germany
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Berlin
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Germany
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Düsseldorf
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Germany
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Erlangen
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Germany
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Frankfurt am Main
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Germany
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Frankfurt
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Germany
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Halle
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Jena
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Germany
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Lemgo
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Germany
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München
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Germany
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Stuttgart
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Germany
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Trier
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Germany
State/province [40] 0 0
Tübingen
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Germany
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Ulm
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Italy
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Emilia-Romagna
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Italy
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Friuli-Venezia Giulia
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Italy
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Lombardia
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Italy
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Marche
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Italy
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Piemonte
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Italy
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Sicilia
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Korea, Republic of
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Seoul
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Lithuania
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Kaunas
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Lithuania
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Vilnius
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Mexico
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Merida
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Mexico
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Mexicali
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Mexico
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Mexico City
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Monterrey
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Obregon
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Mexico
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Puebla
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Netherlands
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Sittard
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Netherlands
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Utrecht
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Panama
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Panama City
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Poland
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Krakow
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Poland
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Olsztyn
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Poland
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Poznan
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Poland
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Warszawa
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Poland
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Wroclaw
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Portugal
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Coimbra
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Portugal
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Lisboa
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Romania
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Bucuresti
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South Africa
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Pretoria
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South Africa
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Sandton
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Spain
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Barcelona
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Spain
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Jaen
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Spain
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Madrid
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Spain
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Malaga
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Sweden
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Linkoeping
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Sweden
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Lund
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Sweden
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Umea
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Switzerland
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Chur
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Taiwan
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Kaohsiung
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Taiwan
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Taipei
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Thailand
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Bangkok
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Thailand
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Khon Kaen
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United Kingdom
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Bournemouth
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United Kingdom
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Cambridge
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United Kingdom
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Edinburgh
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United Kingdom
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Leeds
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Middlesex
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Truro

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

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT00333775
Trial related presentations / publications
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.
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00333775