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A Study Of Sunitinib In Combi...

A Study Of Sunitinib In Combination With Capecitabine Compared With Capecitabine In Patients With Breast Cancer

Last Updated: 2012-06-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

442 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2011-06-30

Brief Summary

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

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Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Sunitinib + Capecitabine

Intervention Type DRUG

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/m\^2 per day \[1000 mg/m\^2 bid (twice daily)\] from days 1-14 every 3 weeks. Study treatment should be given until progression or withdrawal from the study for other reasons.

B

Group Type ACTIVE_COMPARATOR

Capecitabine

Intervention Type DRUG

Capecitabine administered orally at a starting dose of 2500 mg/m\^2 per day \[1250 mg/m\^2 bid (twice daily)\] 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.

Interventions

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Sunitinib + Capecitabine

Intervention Type DRUG

Capecitabine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

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

Downey, California, United States

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Fresno, California, United States

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Montebello, California, United States

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Whittier, California, United States

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Boca Raton, Florida, United States

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Boynton Beach, Florida, United States

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Coral Springs, Florida, United States

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Hollywood, Florida, United States

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Lake Worth, Florida, United States

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Lakeland, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Duluth, Georgia, United States

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Lawrenceville, Georgia, United States

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Snellville, Georgia, United States

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Avon, Indiana, United States

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Indianapolis, Indiana, United States

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Mooresville, Indiana, United States

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Covington, Louisiana, United States

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Gretna, Louisiana, United States

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Marrero, Louisiana, United States

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Metairie, Louisiana, United States

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Metairie, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Kensington, Maryland, United States

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Rockville, Maryland, United States

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Corinth, Mississippi, United States

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Columbia, Missouri, United States

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Billings, Montana, United States

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Albuquerque, New Mexico, United States

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