Clinical trial NCT00373113: A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine
Official title: Phase III Randomized, Multi Center Study Of Sunitinib Malate (SU 011248) Or Capecitabine In Subjects With Advanced Breast Cancer Who Failed Both A Taxane And An Anthracycline Chemotherapy Regimen Or Failed With A Taxane And For Whom Further Anthracycline Therapy Is Not Indicated
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Neoplasms
Keywords: advanced breast cancer
metastatic breast cancer
treatment resistant
treatment failure
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 482
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: To compare efficacy and safety of Sunitinib and Capecitabine in subjects with advanced breast cancer who failed both a taxane and an anthracycline chemotherapy regimen or failed with a taxane and for whom further anthracycline therapy is not indicated

Detailed description: Patient enrollment in this trial was discontinued based on statistical assessment for futility. An independent Data Monitoring Committee found that even if the trial had been allowed to continue, treatment with single agent sunitinib would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared with single agent capecitabine in the study population. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings on 25Mar2009. Patients receiving sunitinib will be allowed to receive capecitabine or enter an extension trial if they are receiving clinical benefit from continued sunitinib therapy. There were no safety concerns leading to the decision to terminate the study.

Eligibility criteria: Inclusion Criteria:

* breast adenocarcinoma
* prior treatment with an anthracycline and a taxane either concurrently or sequentially in the neoadjuvant, adjuvant and or/ advanced disease treatment settings. No more than 1 chemotherapy regimen in the advanced setting

Exclusion Criteria:

* Prior treatment with regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines and taxanes or multiple anthracyclines/ taxanes treatments.
* Any prior regimen with capecitabine

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: From time of randomization to every 6 weeks thereafter through 22 months or until death
Secondary outcomes:
measure: Time to Tumor Progression (TTP)
timeFrame: From time of randomization to every 6 weeks thereafter through 22 months
measure: Number of Participants With Overall Response (OR)
timeFrame: From time of randomization to every 6 weeks thereafter through 22 months
measure: Duration of Response (DR)
timeFrame: From time of randomization to every 6 weeks thereafter through 22 months or death
measure: Time to Tumor Response (TTR)
timeFrame: From time of randomization to every 6 weeks thereafter through 22 months
measure: Overall Survival (OS)
timeFrame: From time of randomization until death
measure: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)
timeFrame: From Day 1 of Cycle 1, then odd numbered cycles thereafter
measure: EORTC QLQ Breast Cancer Module (BR23)
timeFrame: From Day 1 of Cycle 1, then odd numbered cycles thereafter
Other outcomes:
Locations:
city: Bahia Blanca
country: Argentina
facility: Pfizer Investigational Site
state: Prov. de Buenos Aires
city: Viedma
country: Argentina
facility: Pfizer Investigational Site
state: Rio Negro
city: Rosario
country: Argentina
facility: Pfizer Investigational Site
state: Santa Fé
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Cordoba
country: Argentina
facility: Pfizer Investigational Site
city: Tucuman
country: Argentina
facility: Pfizer Investigational Site
city: Darlinghurst
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Herston
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Adelaide
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Heidelberg
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: Pfizer Investigational Site
state: Victoria
city: Perth
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Curitiba
country: Brazil
facility: Pfizer Investigational Site
state: PR
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: Porto Alegre
country: Brazil
facility: Pfizer Investigational Site
state: RS
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Stara Zagora
country: Bulgaria
facility: Pfizer Investigational Site
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Temuco
country: Chile
facility: Pfizer Investigational Site
state: IX Región
city: Medellin
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Bogotá
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Bayonne
country: France
facility: Pfizer Investigational Site
city: Besancon
country: France
facility: Pfizer Investigational Site
city: Clermont Ferrand
country: France
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
city: Neuilly Sur Seine
country: France
facility: Pfizer Investigational Site
city: Nice
country: France
facility: Pfizer Investigational Site
city: Rennes Cedex
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
city: Freiburg
country: Germany
facility: Pfizer Investigational Site
city: Jena
country: Germany
facility: Pfizer Investigational Site
city: Kiel
country: Germany
facility: Pfizer Investigational Site
city: Leer
country: Germany
facility: Pfizer Investigational Site
city: Luebeck
country: Germany
facility: Pfizer Investigational Site
city: Magdeburg
country: Germany
facility: Pfizer Investigational Site
city: Mainz
country: Germany
facility: Pfizer Investigational Site
city: Meiningen
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Offenburg
country: Germany
facility: Pfizer Investigational Site
city: Tuebingen
country: Germany
facility: Pfizer Investigational Site
city: Hong Kong
country: Hong Kong
facility: Pfizer Investigational Site
city: Kowloon
country: Hong Kong
facility: Pfizer Investigational Site
city: Tuen Mun
country: Hong Kong
facility: Pfizer Investigational Site
city: Wan Chai,
country: Hong Kong
facility: Pfizer Investigational Site
city: Navrangpura / Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Bangalore
country: India
facility: Pfizer Investigational Site
state: Karnataka
city: Ludhiana
country: India
facility: Pfizer Investigational Site
state: Punjab
city: Jaipur
country: India
facility: Pfizer Investigational Site
state: Rajasthan
city: Lucknow
country: India
facility: Pfizer Investigational Site
state: Uttar Pradesh
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Reggio Emilia
country: Italy
facility: Pfizer Investigational Site
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Matsuyama-shi
country: Japan
facility: Pfizer Investigational Site
state: Ehime
city: Kitakyushu-City
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Suita
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Kita-adachi-gun
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chuo-Ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Osaka
country: Japan
facility: Pfizer Investigational Site
city: Goyang-si
country: Korea, Republic of
facility: Pfizer Investigational Site
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Incheon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Pusan
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Mexico
country: Mexico
facility: Pfizer Investigational Site
state: DF
city: Toluca
country: Mexico
facility: Pfizer Investigational Site
state: Estado de Mexico
city: Acapulco
country: Mexico
facility: Pfizer Investigational Site
state: Guerrero
city: Morelia
country: Mexico
facility: Pfizer Investigational Site
state: Michoacan
city: Ciudad Obregon
country: Mexico
facility: Pfizer Investigational Site
state: Sonora
city: Chihuahua
country: Mexico
facility: Pfizer Investigational Site
city: Puebla
country: Mexico
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: San Juan City
country: Philippines
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Singapore
country: Singapore
facility: Pfizer Investigational Site
city: Parktown
country: South Africa
facility: Pfizer Investigational Site
city: Sandton
country: South Africa
facility: Pfizer Investigational Site
city: Mataro
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Sabadell
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Santander
country: Spain
facility: Pfizer Investigational Site
state: Cantabria
city: Alcorcon
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Bilbao
country: Spain
facility: Pfizer Investigational Site
state: Vizcaya
city: Cordoba
country: Spain
facility: Pfizer Investigational Site
city: Gerona
country: Spain
facility: Pfizer Investigational Site
city: Jaen
country: Spain
facility: Pfizer Investigational Site
city: La Coruña
country: Spain
facility: Pfizer Investigational Site
city: Las Palmas de Gran Canaria
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Malaga
country: Spain
facility: Pfizer Investigational Site
city: Salamanca
country: Spain
facility: Pfizer Investigational Site
city: Changhua
country: Taiwan
facility: Pfizer Investigational Site
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Tainan
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Taoyuan
country: Taiwan
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Cardiff
country: United Kingdom
facility: Pfizer Investigational Site
state: South Wales
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Nottingham
country: United Kingdom
facility: Pfizer Investigational Site
city: Somerset
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: