A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

NCT ID: NCT00373113

Last Updated: 2012-06-25

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

482 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

1250 mg/m\^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles

Group Type ACTIVE_COMPARATOR

Capecitabine

Intervention Type DRUG

1250 mg/m\^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles

B

37.5 mg daily, continuous dosing

Group Type EXPERIMENTAL

Sunitinib malate

Intervention Type DRUG

37.5 mg daily, continuous dosing

Interventions

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Capecitabine

1250 mg/m\^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles

Intervention Type DRUG

Sunitinib malate

37.5 mg daily, continuous dosing

Intervention Type DRUG

Other Intervention Names

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xeloda sunitinib

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Córdoba, Córdoba Province, Argentina

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Bahía Blanca, Prov. de Buenos Aires, Argentina

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Viedma, Río Negro Province, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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San Miguel de Tucumán, , Argentina

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Darlinghurst, New South Wales, Australia

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Herston, Queensland, Australia

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Adelaide, South Australia, Australia

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Heidelberg, Victoria, Australia

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Parkville, Victoria, Australia

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Perth, Western Australia, Australia

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Curitiba, Paraná, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Sofia, Bulgaria, Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Stara Zagora, , Bulgaria

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Halifax, Nova Scotia, Canada

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Halifax, Nova Scotia, Canada

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Halifax, Nova Scotia, Canada

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London, Ontario, Canada

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Toronto, Ontario, Canada

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Québec, Quebec, Canada

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Temuco, Región de la Araucanía, Chile

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Medellín, Antioquia, Colombia

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Bogotá, Cundinamarca, Colombia

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Bayonne, , France

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Besançon, , France

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Clermont-Ferrand, , France

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Lille, , France

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Neuilly-sur-Seine, , France

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Nice, , France

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Rennes, , France

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Berlin, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Jena, , Germany

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Kiel, , Germany

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Leer, , Germany

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Lübeck, , Germany

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Magdeburg, , Germany

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Mainz, , Germany

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Meiningen, , Germany

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München, , Germany

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Offenburg, , Germany

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Tübingen, , Germany

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Hong Kong, , Hong Kong

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Kowloon, , Hong Kong

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Tuenmen, , Hong Kong

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Wan Chai, , Hong Kong

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Navrangpura / Ahmedabad, Gujarat, India

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Bangalore, Karnataka, India

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Ludhiana, Punjab, India

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Jaipur, Rajasthan, India

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Lucknow, Uttar Pradesh, India

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Florence, , Italy

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Milan, , Italy

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Napoli, , Italy

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Reggio Emilia, , Italy

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Nagoya, Aichi-ken, Japan

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Matsuyama, Ehime, Japan

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Fukuoka, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Osaka, Osaka, Japan

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Suita, Osaka, Japan

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Kita-adachi-gun, Saitama, Japan

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Bunkyo-ku, Tokyo, Japan

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Chuo-Ku, Tokyo, Japan

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Chihuahua City, Chihuahua, Mexico

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Acapulco de Juárez, Guerrero, Mexico

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Mexico City, Mexico City, Mexico

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Morelia, Michoacán, Mexico

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Puebla City, Puebla, Mexico

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Ciudad Obregón, Sonora, Mexico

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Toluca, State of Mexico, Mexico

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Lima, Lima Province, Peru

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Lima, , Peru

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Quezon City, , Philippines

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Quezon City, , Philippines

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Quezon City, , Philippines

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San Juan City, , Philippines

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Singapore, Singapore, Singapore

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Singapore, Singapore, Singapore

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Parktown, , South Africa

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Sandton, , South Africa

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Goyang-si, Gyeonggi-do, South Korea

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Daegu, , South Korea

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Incheon, , South Korea

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Pusan, , South Korea

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Seoul, , South Korea

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Mataró, Barcelona, Spain

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Sabadell, Barcelona, Spain

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Santander, Cantabria, Spain

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Córdoba, Cordoba, Spain

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Girona, Gerona, Spain

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Jaén, Jaen, Spain

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A Coruña, La Coruña, Spain

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Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, Spain

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Alcorcón, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Málaga, Malaga, Spain

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Salamanca, Salamanca, Spain

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Bilbao, Vizcaya, Spain

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Changhua, , Taiwan

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Kaohsiung City, , Taiwan

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Tainan City, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taipei, , Taiwan

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Taoyuan District, , Taiwan

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Ankara, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Cardiff, South Wales, United Kingdom

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London, , United Kingdom

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Nottingham, , United Kingdom

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Somerset, , United Kingdom

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Countries

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Argentina Australia Brazil Bulgaria Canada Chile Colombia France Germany Hong Kong India Italy Japan Mexico Peru Philippines Singapore South Africa South Korea Spain Taiwan Turkey (Türkiye) United Kingdom

Related Links

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Other Identifiers

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A6181107

Identifier Type: -

Identifier Source: org_study_id

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