A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00435409

Purpose

The treatment received with sunitinib plus capecitabine could delay tumor growth longer than with treatment with capecitabine alone.

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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Sunitinib Sunitinib malate Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Phase 3 Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Previously Treated Breast Cancer

Further study details as provided by Pfizer:

Primary Outcome Measures:

Progression free survival [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient reported outcomes [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]
2-and 3 year survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Overall response rate [ Time Frame: Until response or disease progression ] [ Designated as safety issue: No ]
Duration of response [ Time Frame: Until response or disease progression ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Overall safety profile [ Time Frame: Until disease progression ] [ Designated as safety issue: No ]

Estimated Enrollment:	430
Study Start Date:	February 2007
Estimated Study Completion Date:	February 2012
Estimated Primary Completion Date:	February 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: Sunitinib + Capecitabine Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m2 per day (1000 mg/m2 bid) from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons.
B: Active Comparator	Drug: Capecitabine Capecitabine administered orally at a starting dose of 2500 mg/m2 per day (1500 mg/m2 bid) from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons. At the time of progression, patients may be eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily.

Eligibility

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

Criteria

Inclusion Criteria:

Locally advanced or metastatic disease that can be measured. Patients with bone-only disease are also allowed to enter the study.
Previous treatment with an anthracycline and a taxane in any setting
Progression on first or second line regimen or adjuvant regimen if disease free interval less than 12 months

Exclusion Criteria:

History of inflammatory carcinoma if there is no other measurable disease
More than 2 chemotherapy agents in the advanced disease setting
Brain metastases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00435409

Contacts

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

Show 185 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:	A6181099
Study First Received:	February 13, 2007
Last Updated:	January 1, 2009
ClinicalTrials.gov Identifier:	NCT00435409
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Capecitabine
Skin Diseases
Sunitinib

Fluorouracil
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Immunosuppressive Agents

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

ClinicalTrials.gov processed this record on January 16, 2009