A Clinical Trial Comparing Efficacy And Safety of Sunitinib And Capecitabine - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00373113

Purpose

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

Condition	Intervention	Phase
Breast Neoplasms	Drug: Capecitabine Drug: Sunitinib malate	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Sunitinib Sunitinib malate Capecitabine Malic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Progression-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to Tumor Response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Patient-reported outcomes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Safety: Type, incidence, severity, seriousness, and relatedness of adverse events and laboratory abnormalities [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Time to Tumor Progression [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Overall Response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	700
Study Start Date:	November 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator 1250 mg/m2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles	Drug: Capecitabine 1250 mg/m2, twice daily, for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
B: Experimental 37.5 mg daily, continuous dosing	Drug: Sunitinib malate 37.5 mg daily, continuous dosing

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373113

Contacts

Contact: Pfizer Oncology Clinical Trial Information Service?????	1-877-369-9753	PfizerCancerTrials@emergingmed.com
Contact: Pfizer CT.gov Call Center	1-800-718-1021

Show 122 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6181107
Study First Received:	September 5, 2006
Last Updated:	January 4, 2009
ClinicalTrials.gov Identifier:	NCT00373113
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

advanced breast cancer, metastatic breast cancer, treatment resistant, treatment failure

Study placed in the following topic categories:

Capecitabine
Skin Diseases
Sunitinib

Breast Neoplasms
Taxane
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Angiogenesis Inhibitors

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009