A Clinical Trial Comparing Efficacy And Safety Of Sunitinib And Capecitabine

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00373113
• Other study ID #: A6181107
• Status: Terminated
• Phase: Phase 3
• First received: September 5, 2006
• Last updated: June 15, 2012
• Start date: November 2006
• Est. completion date: June 2011

Study information

• Verified date: June 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 482
• Est. completion date: June 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• Capecitabine
1250 mg/m^2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
• Sunitinib malate
37.5 mg daily, continuous dosing

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Bahia Blanca	Prov. de Buenos Aires
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Cordoba
Argentina	Pfizer Investigational Site	Rosario	Santa Fé
Argentina	Pfizer Investigational Site	Tucuman
Argentina	Pfizer Investigational Site	Viedma	Rio Negro
Australia	Pfizer Investigational Site	Adelaide	South Australia
Australia	Pfizer Investigational Site	Darlinghurst	New South Wales
Australia	Pfizer Investigational Site	Heidelberg	Victoria
Australia	Pfizer Investigational Site	Herston	Queensland
Australia	Pfizer Investigational Site	Parkville	Victoria
Australia	Pfizer Investigational Site	Perth	Western Australia
Brazil	Pfizer Investigational Site	Curitiba	PR
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Porto Alegre	RS
Brazil	Pfizer Investigational Site	Rio de Janeiro	RJ
Brazil	Pfizer Investigational Site	São Paulo	SP
Brazil	Pfizer Investigational Site	São Paulo	SP
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Stara Zagora
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	Halifax	Nova Scotia
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Chile	Pfizer Investigational Site	Temuco	IX Región
Colombia	Pfizer Investigational Site	Bogotá	Cundinamarca
Colombia	Pfizer Investigational Site	Medellin	Antioquia
France	Pfizer Investigational Site	Bayonne
France	Pfizer Investigational Site	Besancon
France	Pfizer Investigational Site	Clermont Ferrand
France	Pfizer Investigational Site	Lille
France	Pfizer Investigational Site	Neuilly Sur Seine
France	Pfizer Investigational Site	Nice
France	Pfizer Investigational Site	Rennes Cedex
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Frankfurt
Germany	Pfizer Investigational Site	Freiburg
Germany	Pfizer Investigational Site	Jena
Germany	Pfizer Investigational Site	Kiel
Germany	Pfizer Investigational Site	Leer
Germany	Pfizer Investigational Site	Luebeck
Germany	Pfizer Investigational Site	Magdeburg
Germany	Pfizer Investigational Site	Mainz
Germany	Pfizer Investigational Site	Meiningen
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Offenburg
Germany	Pfizer Investigational Site	Tuebingen
Hong Kong	Pfizer Investigational Site	Hong Kong
Hong Kong	Pfizer Investigational Site	Kowloon
Hong Kong	Pfizer Investigational Site	Tuen Mun
Hong Kong	Pfizer Investigational Site	Wan Chai,
India	Pfizer Investigational Site	Bangalore	Karnataka
India	Pfizer Investigational Site	Jaipur	Rajasthan
India	Pfizer Investigational Site	Lucknow	Uttar Pradesh
India	Pfizer Investigational Site	Ludhiana	Punjab
India	Pfizer Investigational Site	Navrangpura / Ahmedabad	Gujarat
Italy	Pfizer Investigational Site	Firenze
Italy	Pfizer Investigational Site	Milano
Italy	Pfizer Investigational Site	Napoli
Italy	Pfizer Investigational Site	Reggio Emilia
Japan	Pfizer Investigational Site	Bunkyo-ku	Tokyo
Japan	Pfizer Investigational Site	Chuo-Ku	Tokyo
Japan	Pfizer Investigational Site	Fukuoka
Japan	Pfizer Investigational Site	Kita-adachi-gun	Saitama
Japan	Pfizer Investigational Site	Kitakyushu-City	Fukuoka
Japan	Pfizer Investigational Site	Matsuyama-shi	Ehime
Japan	Pfizer Investigational Site	Nagoya	Aichi
Japan	Pfizer Investigational Site	Osaka
Japan	Pfizer Investigational Site	Suita	Osaka
Korea, Republic of	Pfizer Investigational Site	Daegu
Korea, Republic of	Pfizer Investigational Site	Goyang-si	Gyeonggi-do
Korea, Republic of	Pfizer Investigational Site	Incheon
Korea, Republic of	Pfizer Investigational Site	Pusan
Korea, Republic of	Pfizer Investigational Site	Seoul
Mexico	Pfizer Investigational Site	Acapulco	Guerrero
Mexico	Pfizer Investigational Site	Chihuahua
Mexico	Pfizer Investigational Site	Ciudad Obregon	Sonora
Mexico	Pfizer Investigational Site	Mexico	DF
Mexico	Pfizer Investigational Site	Morelia	Michoacan
Mexico	Pfizer Investigational Site	Puebla
Mexico	Pfizer Investigational Site	Toluca	Estado de Mexico
Peru	Pfizer Investigational Site	Lima
Peru	Pfizer Investigational Site	Lima
Philippines	Pfizer Investigational Site	Quezon City
Philippines	Pfizer Investigational Site	Quezon City
Philippines	Pfizer Investigational Site	Quezon City
Philippines	Pfizer Investigational Site	San Juan City
Singapore	Pfizer Investigational Site	Singapore
Singapore	Pfizer Investigational Site	Singapore
South Africa	Pfizer Investigational Site	Parktown
South Africa	Pfizer Investigational Site	Sandton
Spain	Pfizer Investigational Site	Alcorcon	Madrid
Spain	Pfizer Investigational Site	Bilbao	Vizcaya
Spain	Pfizer Investigational Site	Cordoba
Spain	Pfizer Investigational Site	Gerona
Spain	Pfizer Investigational Site	Jaen
Spain	Pfizer Investigational Site	La Coruña
Spain	Pfizer Investigational Site	Las Palmas de Gran Canaria
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Malaga
Spain	Pfizer Investigational Site	Mataro	Barcelona
Spain	Pfizer Investigational Site	Sabadell	Barcelona
Spain	Pfizer Investigational Site	Salamanca
Spain	Pfizer Investigational Site	Santander	Cantabria
Taiwan	Pfizer Investigational Site	Changhua
Taiwan	Pfizer Investigational Site	Kaohsiung
Taiwan	Pfizer Investigational Site	Tainan
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taoyuan
Turkey	Pfizer Investigational Site	Ankara
Turkey	Pfizer Investigational Site	Istanbul
United Kingdom	Pfizer Investigational Site	Cardiff	South Wales
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Nottingham
United Kingdom	Pfizer Investigational Site	Somerset

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Time to Tumor Progression (TTP)	Time from randomization to first documentation of objective tumor progression.	From time of randomization to every 6 weeks thereafter through 22 months	No
Secondary	Number of Participants With Overall Response (OR)	OR was defined as the number of participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.0) for at least 4 weeks, confirmed by repeat tumor assessments. CR was defined as the disappearance of all target lesions. PR was defined as a greater than or equal to (>=) 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.	From time of randomization to every 6 weeks thereafter through 22 months	No
Secondary	Duration of Response (DR)	Time from the first documentation of OR (CR or PR) that was subsequently confirmed to the first documentation of tumor progression or death due to any cause. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.	From time of randomization to every 6 weeks thereafter through 22 months or death	No
Secondary	Time to Tumor Response (TTR)	Time from randomization to the first documentation of objective tumor response (CR or PR) that was subsequently confirmed. CR was defined as disappearance of all target lesions. PR was defined as a >= 30% decrease in sum of longest dimensions of target lesions taking as a reference baseline sum longest dimensions.	From time of randomization to every 6 weeks thereafter through 22 months	No
Secondary	Overall Survival (OS)	Average time from randomization to first documentation of death due to any cause.	From time of randomization until death	No
Secondary	European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30)	EORTC QLQ-C30 scales: functional (physical/role/cognitive/emotional/social), symptom (fatigue/nausea/vomiting/pain), global health/QOL, cancer symptom (dyspnea/insomnia/appetite loss/constipation/diarrhea).; Feelings in past week: response range: not at all to very much, global/QOL range: very poor to excellent. Scales/single-items averaged, score 0 to 100. Higher functional/global=better functioning and symptom=greater degree of symptoms.	From Day 1 of Cycle 1, then odd numbered cycles thereafter	No
Secondary	EORTC QLQ Breast Cancer Module (BR23)	BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much.; Scale score range: 0 to 100. Higher symptom score implied a greater degree of symptoms.	From Day 1 of Cycle 1, then odd numbered cycles thereafter	No

External Links

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