Clinical trial NCT00333775: A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-06-06
Enrollment: 736
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

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.

Primary outcomes:
measure: Progression-free Survival
timeFrame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)
Secondary outcomes:
measure: Percentage of Participants With a Complete Response or a Partial Response
timeFrame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)
measure: Duration of Response
timeFrame: Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)
measure: Time to Treatment Failure
timeFrame: Baseline to the 15 September 2008 cut-off date (up to 2 years, 6 months)
measure: Overall Survival
timeFrame: Baseline to the 15 Sep 2008 cut-off date (up to 2 years, 6 months)
Other outcomes:
Locations:
city: Adelaide
country: Australia
state: New South Wales
city: Camperdown
country: Australia
state: New South Wales
city: Westmead
country: Australia
state: New South Wales
city: Auchenflower
country: Australia
state: Queensland
city: Box Hill
country: Australia
state: Victoria
city: Fitzroy
country: Australia
state: Victoria
city: Ringwood East
country: Australia
state: Victoria
city: Perth
country: Australia
state: Western Australia
city: Graz
country: Austria
city: Salzburg
country: Austria
city: Vöcklabruck
country: Austria
city: Wien
country: Austria
city: Bruxelles
country: Belgium
city: Wilrijk
country: Belgium
city: Goiania
country: Brazil
state: GO
city: Belo Horizonte
country: Brazil
state: MG
city: Porto Alegre
country: Brazil
state: RS
city: Florianopolis
country: Brazil
state: SC
city: Barretos
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Halifax
country: Canada
state: Nova Scotia
city: Ottawa
country: Canada
state: Ontario
city: Sudbury
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Beijing
country: China
city: Besancon
country: France
city: Bordeaux
country: France
city: Caen
country: France
city: Clermont Ferrand
country: France
city: Dijon
country: France
city: Lille
country: France
city: Montpellier
country: France
city: Villejuif
country: France
city: Ansbach
country: Germany
city: Berlin
country: Germany
city: Düsseldorf
country: Germany
city: Erlangen
country: Germany
city: Frankfurt am Main
country: Germany
city: Frankfurt
country: Germany
city: Halle
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Jena
country: Germany
city: Lemgo
country: Germany
city: München
country: Germany
city: Stuttgart
country: Germany
city: Trier
country: Germany
city: Tübingen
country: Germany
city: Ulm
country: Germany
city: Bologna
country: Italy
state: Emilia-Romagna
city: Modena
country: Italy
state: Emilia-Romagna
city: Parma
country: Italy
state: Emilia-Romagna
city: Trieste
country: Italy
state: Friuli-Venezia Giulia
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Treviglio
country: Italy
state: Lombardia
city: Macerata
country: Italy
state: Marche
city: Biella
country: Italy
state: Piemonte
city: Taormina
country: Italy
state: Sicilia
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Merida
country: Mexico
city: Mexicali
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: Obregon
country: Mexico
city: Puebla
country: Mexico
city: Sittard
country: Netherlands
city: Utrecht
country: Netherlands
city: Panama City
country: Panama
city: Krakow
country: Poland
city: Olsztyn
country: Poland
city: Poznan
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Coimbra
country: Portugal
city: Lisboa
country: Portugal
city: Bucuresti
country: Romania
city: Pretoria
country: South Africa
city: Sandton
country: South Africa
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Jaen
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Linkoeping
country: Sweden
city: Lund
country: Sweden
city: Umea
country: Sweden
city: Chur
country: Switzerland
city: Kaohsiung
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Bangkok
country: Thailand
city: Bangkok
country: Thailand
city: Khon Kaen
country: Thailand
city: Bournemouth
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Leeds
country: United Kingdom
city: Leeds
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Middlesex
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Truro
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.