Clinical trial NCT00393939: Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer
Official title: A Randomized Phase 3 Study Of Docetaxel In Combination With Sunitinib Versus Docetaxel In The First-Line Treatment Of Advanced Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Neoplasms
Keywords: advanced breast cancer
sunitinib
docetaxel
Phase 3
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-10-31
Enrollment: 594
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 is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib combined with docetaxel versus docetaxel, administered as first-line treatment, in patients with unresectable locally recurrent or metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* Breast cancer with evidence of unresectable locally recurrent, or metastatic disease
* Her-2 negative tumors

Exclusion Criteria:

* Patients for whom docetaxel is contraindicated
* Clinical presentation of inflammatory carcinoma with no other measurable disease

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline up to Month 33
Secondary outcomes:
measure: Percentage of Participants With Objective Response
timeFrame: Baseline up to Month 33
measure: Duration of Response (DR)
timeFrame: Baseline up to Month 33
measure: Overall Survival (OS)
timeFrame: Baseline to date of death from any cause (up to Month 33)
measure: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionaire-C30 (EORTC- QLQ-C30) Score
timeFrame: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)
measure: Change From Baseline in EORTC-QLQ Breast Cancer Module (EORTC-QLQ-BR23) Score
timeFrame: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)
measure: Change From Baseline European Quality of Life 5-dimensional Self-Report Questionnaire (EQ-5D) Score
timeFrame: Baseline, every 6 weeks up to end of treatment or early termination (up to Month 33)
Other outcomes:
Locations:
city: Berkely
country: United States
facility: Pfizer Investigational Site
state: California
city: Shreveport
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Beaumont
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Burleson
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Cleburne
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Mineral Wells
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Weatherford
country: United States
facility: Pfizer Investigational Site
state: Texas
city: La Plata
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Pergamino
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Burnos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Tweed Heads
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Redcliffe
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Brighton
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Malvern
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Ringwood East
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Perth
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Salzburg
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Brasschaat
country: Belgium
facility: Pfizer Investigational Site
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
city: Verviers
country: Belgium
facility: Pfizer Investigational Site
city: Surrey
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Pereira
country: Colombia
facility: Pfizer Investigational Site
state: Risaralda
city: Cali
country: Colombia
facility: Pfizer Investigational Site
state: Valle del Cauca
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Novy Jicin
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 5
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 8
country: Czech Republic
facility: Pfizer Investigational Site
city: Tampere
country: Finland
facility: Pfizer Investigational Site
city: Turku
country: Finland
facility: Pfizer Investigational Site
city: Bordeaux CEDEX
country: France
facility: Pfizer Investigational Site
city: Dijon
country: France
facility: Pfizer Investigational Site
city: NANTES Cedex 2
country: France
facility: Pfizer Investigational Site
city: Reims
country: France
facility: Pfizer Investigational Site
city: Saint Cloud
country: France
facility: Pfizer Investigational Site
city: Saint-Priest-en-Jarez Cedex
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Tours
country: France
facility: Pfizer Investigational Site
city: Villejuif
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Chemnitz
country: Germany
facility: Pfizer Investigational Site
city: Essen
country: Germany
facility: Pfizer Investigational Site
city: Hildesheim
country: Germany
facility: Pfizer Investigational Site
city: Karlsruhe
country: Germany
facility: Pfizer Investigational Site
city: Leverkusen
country: Germany
facility: Pfizer Investigational Site
city: Magdeburg
country: Germany
facility: Pfizer Investigational Site
city: Marburg
country: Germany
facility: Pfizer Investigational Site
city: Oldenburg
country: Germany
facility: Pfizer Investigational Site
city: Ravensburg
country: Germany
facility: Pfizer Investigational Site
city: Rosenheim
country: Germany
facility: Pfizer Investigational Site
city: Wuerzburg
country: Germany
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Kaposvar
country: Hungary
facility: Pfizer Investigational Site
city: Szentes
country: Hungary
facility: Pfizer Investigational Site
city: Dublin
country: Ireland
facility: Pfizer Investigational Site
city: Dublin
country: Ireland
facility: Pfizer Investigational Site
city: Dublin
country: Ireland
facility: Pfizer Investigational Site
city: Galway
country: Ireland
facility: Pfizer Investigational Site
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Cattolica (RN)
country: Italy
facility: Pfizer Investigational Site
city: Cefalu' (PA)
country: Italy
facility: Pfizer Investigational Site
city: Chieti Scalo
country: Italy
facility: Pfizer Investigational Site
city: Lecce
country: Italy
facility: Pfizer Investigational Site
city: Livorno
country: Italy
facility: Pfizer Investigational Site
city: Macerata
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Palermo
country: Italy
facility: Pfizer Investigational Site
city: Pavia
country: Italy
facility: Pfizer Investigational Site
city: Rimini
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Goyang-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
city: Utrecht
country: Netherlands
facility: Pfizer Investigational Site
city: Venlo
country: Netherlands
facility: Pfizer Investigational Site
city: Panama
country: Panama
facility: Pfizer Investigational Site
city: Gdansk
country: Poland
facility: Pfizer Investigational Site
city: Lubin
country: Poland
facility: Pfizer Investigational Site
city: Poznan
country: Poland
facility: Pfizer Investigational Site
city: Rybnik
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Coimbra
country: Portugal
facility: Pfizer Investigational Site
city: Lisboa
country: Portugal
facility: Pfizer Investigational Site
city: Porto
country: Portugal
facility: Pfizer Investigational Site
city: Santa Maria da Feira
country: Portugal
facility: Pfizer Investigational Site
city: Cluj Napoca
country: Romania
facility: Pfizer Investigational Site
state: Cluj
city: Cluj Napoca
country: Romania
facility: Pfizer Investigational Site
state: Cluj
city: Craiova
country: Romania
facility: Pfizer Investigational Site
state: Dolj
city: Bucuresti
country: Romania
facility: Pfizer Investigational Site
state: Sector 2
city: Kuzmolovo, Vsevolozhsk district
country: Russian Federation
facility: Pfizer Investigational Site
state: Leningrad region
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Banska Bystrica
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Nitra
country: Slovakia
facility: Pfizer Investigational Site
city: Palma de Mallorca
country: Spain
facility: Pfizer Investigational Site
state: Baleares
city: Santiago de Compostela
country: Spain
facility: Pfizer Investigational Site
state: La Coruña
city: Dos Hermanas
country: Spain
facility: Pfizer Investigational Site
state: Sevilla
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Santa Cruz de Tenerife
country: Spain
facility: Pfizer Investigational Site
city: Toledo
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Zaragoza
country: Spain
facility: Pfizer Investigational Site
city: Helsingborg
country: Sweden
facility: Pfizer Investigational Site
city: Karlstad
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Uppsala
country: Sweden
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Gaziantep
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Pfizer Investigational Site
city: Donetsk
country: Ukraine
facility: Pfizer Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Kyiv
country: Ukraine
facility: Pfizer Investigational Site
city: Lviv
country: Ukraine
facility: Pfizer Investigational Site
city: Cheltenham
country: United Kingdom
facility: Pfizer Investigational Site
state: Gloucestershire
city: Maidstone
country: United Kingdom
facility: Pfizer Investigational Site
state: Kent
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
state: M20 4bx
city: Wirral
country: United Kingdom
facility: Pfizer Investigational Site
state: Merseyside
city: Shrewsbury
country: United Kingdom
facility: Pfizer Investigational Site
state: Shropshire
city: Telford
country: United Kingdom
facility: Pfizer Investigational Site
state: Shropshire
city: Guildford
country: United Kingdom
facility: Pfizer Investigational Site
state: Surrey
city: Worthing
country: United Kingdom
facility: Pfizer Investigational Site
state: West Sussex
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Wolverhampton
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: