A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

NCT00373113 | Terminated Phase 3 Results DMC

• 1 other identifier: A6181107
• Study Type: interventional
• Target: 482
• Locations: 23 countries
• Sites: 123

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

Conditions

Breast Neoplasms

Keywords

advanced breast cancer; metastatic breast cancer; treatment resistant; treatment failure

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Time from the date of randomization to the date of the first documentation of objective tumor progression or death due to any cause, whichever occured first.

  From time of randomization to every 6 weeks thereafter through 22 months or until death

Secondary Outcomes (7)

• Time to Tumor Progression (TTP)

  From time of randomization to every 6 weeks thereafter through 22 months

• Number of Participants With Overall Response (OR)

  From time of randomization to every 6 weeks thereafter through 22 months

• Duration of Response (DR)

  From time of randomization to every 6 weeks thereafter through 22 months or death

• Time to Tumor Response (TTR)

  From time of randomization to every 6 weeks thereafter through 22 months

• Overall Survival (OS)

  From time of randomization until death

Study Arms (2)

A

ACTIVE COMPARATOR

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

Drug: Capecitabine

B

EXPERIMENTAL

37.5 mg daily, continuous dosing

Drug: Sunitinib malate

Interventions

Capecitabine DRUG

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

Also known as: xeloda

A

Sunitinib malate DRUG

37.5 mg daily, continuous dosing

Also known as: sunitinib

B

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (123)

Pfizer Investigational Site

Córdoba, Córdoba Province, X5000AAI, Argentina

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Bahía Blanca, Prov. de Buenos Aires, B8001HXM, Argentina

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Viedma, Río Negro Province, 8500, Argentina

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Rosario, Santa Fe Province, (2000), Argentina

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Buenos Aires, C1034ACO, Argentina

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Buenos Aires, C1405BCH, Argentina

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San Miguel de Tucumán, T4000IAK, Argentina

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Darlinghurst, New South Wales, 2010, Australia

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Herston, Queensland, 4029, Australia

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Adelaide, South Australia, 5000, Australia

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Heidelberg, Victoria, 3084, Australia

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Parkville, Victoria, 3050, Australia

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Perth, Western Australia, 6000, Australia

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Curitiba, Paraná, 80530-010, Brazil

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Rio de Janeiro, Rio de Janeiro, 20560-120, Brazil

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Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

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Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

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São Paulo, São Paulo, 01246-000, Brazil

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São Paulo, São Paulo, 01509-900, Brazil

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Sofia, Bulgaria, 1756, Bulgaria

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Sofia, 1233, Bulgaria

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Sofia, 1527, Bulgaria

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Stara Zagora, 6000, Bulgaria

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Halifax, Nova Scotia, B3H 1V7, Canada

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Halifax, Nova Scotia, B3H 2Y9, Canada

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Halifax, Nova Scotia, B3H 3A7, Canada

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London, Ontario, N6A 4L6, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Québec, Quebec, G1S 4L8, Canada

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Temuco, Región de la Araucanía, 4810469, Chile

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Medellín, Antioquia, Colombia

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Bogotá, Cundinamarca, Colombia

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Bayonne, 64100, France

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Besançon, 25030, France

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Clermont-Ferrand, 63011, France

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Lille, 59020 Cedex, France

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Neuilly-sur-Seine, 92200, France

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Nice, 06100, France

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Rennes, 35042, France

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Berlin, 12200, Germany

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Frankfurt, 60488, Germany

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Freiburg im Breisgau, 79106, Germany

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Jena, 07743, Germany

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Kiel, 24103, Germany

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Leer, 26789, Germany

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Lübeck, 23538, Germany

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Magdeburg, 39130, Germany

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Mainz, 55101, Germany

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Meiningen, 98617, Germany

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München, 81675, Germany

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Offenburg, 77652, Germany

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Tübingen, 72076, 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, 380 009, India

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Bangalore, Karnataka, 560 078, India

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Ludhiana, Punjab, 141 008, India

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Jaipur, Rajasthan, 302013, India

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Lucknow, Uttar Pradesh, 226003, India

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Florence, 50134, Italy

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Milan, 20162, Italy

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Napoli, 80131, Italy

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Reggio Emilia, 42100, 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, 31000, Mexico

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Acapulco de Juárez, Guerrero, 39670, Mexico

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Mexico City, Mexico City, 11000, Mexico

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Morelia, Michoacán, 58020, Mexico

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Puebla City, Puebla, 72530, Mexico

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Ciudad Obregón, Sonora, 85000, Mexico

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Toluca, State of Mexico, 50180, Mexico

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Lima, Lima Province, 05127, Peru

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Lima, L 27, Peru

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Quezon City, 1100, Philippines

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Quezon City, 1102, Philippines

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Quezon City, 1104, Philippines

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San Juan City, 1000, Philippines

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Singapore, Singapore, 119074, Singapore

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Singapore, Singapore, 169610, Singapore

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Parktown, 2193, South Africa

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Sandton, 2199, South Africa

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Goyang-si, Gyeonggi-do, 410-769, South Korea

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Daegu, 705-717, South Korea

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Incheon, 400-711, South Korea

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Pusan, 602-739, South Korea

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Seoul, 110-744, South Korea

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Mataró, Barcelona, 08304, Spain

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Sabadell, Barcelona, 08208, Spain

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Santander, Cantabria, 39008, Spain

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Córdoba, Cordoba, 14004, Spain

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Girona, Gerona, 17007, Spain

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Jaén, Jaen, 23007, Spain

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A Coruña, La Coruña, 15006, Spain

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Las Palmas de Gran Canaria, Las Palmas de Gran Canaria, 35016, Spain

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Alcorcón, Madrid, 28922, Spain

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Madrid, Madrid, 28033, Spain

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Madrid, Madrid, 28040, Spain

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Málaga, Malaga, 29010, Spain

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Salamanca, Salamanca, 37007, Spain

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Bilbao, Vizcaya, 48013, Spain

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Changhua, 500, Taiwan

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Kaohsiung City, 807, Taiwan

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Tainan, 704, Taiwan

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Taipei, 100, Taiwan

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Taipei, 106, Taiwan

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Taipei, 112, Taiwan

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Taoyuan District, 333, Taiwan

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Ankara, 06100, Turkey (Türkiye)

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Istanbul, 34390, Turkey (Türkiye)

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Cardiff, South Wales, CF14 2TL, United Kingdom

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London, SE1 9RT, United Kingdom

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Nottingham, NG5 1PB, United Kingdom

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Somerset, BA21 4AT, United Kingdom

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Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Sunitinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pyrroles; Azoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

Due to patient enrollment termination, PFS/OR/TTP/DR were done by investigator assessment due to lack of central review data and TTR/EORTC QLQ-C30/QLQ BR23 analyses were not done. Those enrolled could receive capecitabine or enter an extension trial.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2006
• First Posted: September 7, 2006
• Study Start: November 1, 2006
• Primary Completion: October 1, 2009
• Study Completion: June 1, 2011
• Last Updated: June 25, 2012
• Results First Posted: November 18, 2010

Record last verified: 2012-06

Locations

HK (4); JP (9); GB (4); BU (4); AR (7); IT (4); PE (2); SG (2); IN (5); ZA (2); AU (6); CA (6); CL (1); ES (14); KR (5); TU (2); ME (7); DE (13); TW (7); FR (7); PH (4); CO (2); BR (6)