Efficacy And Safety Of Sunitinib In Women With Advanced Breast Cancer

NCT ID: NCT00471276

Last Updated: 2011-07-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-06-30

Brief Summary

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Patients with advanced breast cancer to receive sunitinib (Sutent) once daily until disease progression.

Detailed Description

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Conditions

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Breast Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

sunitinib

Intervention Type DRUG

sunitinib (Sutent), 37.5 mg, daily dosing

Interventions

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sunitinib

sunitinib (Sutent), 37.5 mg, daily dosing

Intervention Type DRUG

Other Intervention Names

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Sutent, sunitinib

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically proven diagnosis of breast cancer
* Metastatic or locally recurrent disease that is, in the opinion of the investigator, not amenable to resection or radiation therapy
* Patients with at least one measurable lesion as per RECIST

Exclusion Criteria

* Inflammatory breast cancer
* Prior treatment with VEGF inhibitors (unless in adjuvant setting at least 12 months ago)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Bakersfield, California, United States

Site Status

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Burbank, California, United States

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Fountain Valley, California, United States

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Hawthorne, California, United States

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Long Beach, California, United States

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Boynton Beach, Florida, United States

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Zion, Illinois, United States

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Louisville, Kentucky, United States

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Kalamazoo, Michigan, United States

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Maple Grove, Minnesota, United States

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Minneapolis, Minnesota, United States

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Minneapolis, Minnesota, United States

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Columbia, Missouri, United States

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Asheville, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Kernersville, North Carolina, United States

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Lexington, North Carolina, United States

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North Wilkesboro, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Franklin, Tennessee, United States

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Gallatin, Tennessee, United States

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Hermitage, Tennessee, United States

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Lebanon, Tennessee, United States

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Murfreesboro, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Smyrna, Tennessee, United States

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Everett, Washington, United States

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Countries

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United States

Related Links

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Other Identifiers

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A6181068

Identifier Type: -

Identifier Source: org_study_id

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