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A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer

NCT ID: NCT00373256

Last Updated: 2012-09-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

488 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2011-08-31

Brief Summary

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To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer

Detailed Description

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On May 27, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181094. The DMC determined Study A6181094 had met pre-specified futility criteria and was unlikely to meet its primary endpoint to demonstrate a statistically significant improvement in progression-free survival (PFS) in patients treated with sunitinib plus paclitaxel versus bevacizumab plus paclitaxel. Pfizer notified clinical trial investigators involved in the study and regulatory agencies of these findings. Enrollment in this study has been stopped.

Conditions

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Breast Neoplasms

Keywords

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Breast cancer advanced sunitinib bevacizumab paclitaxel Phase 3

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Sunitinib

Intervention Type DRUG

Sunitinib 25 mg daily by oral capsules with titration up to 37.5 mg,

paclitaxel

Intervention Type DRUG

Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.

B

Group Type ACTIVE_COMPARATOR

bevacizumab

Intervention Type DRUG

Bevacizumab 10 mg/kg IV every 2 weeks.

paclitaxel

Intervention Type DRUG

Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.

Interventions

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Sunitinib

Sunitinib 25 mg daily by oral capsules with titration up to 37.5 mg,

Intervention Type DRUG

paclitaxel

Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.

Intervention Type DRUG

bevacizumab

Bevacizumab 10 mg/kg IV every 2 weeks.

Intervention Type DRUG

paclitaxel

Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.

Intervention Type DRUG

Other Intervention Names

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SU011248, Sutent Avastin

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of advanced breast cancer.
* Measurable disease as per RECIST (Response Evaluation Criterion) in Solid Tumors or bone-only disease.
* ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.

Exclusion Criteria

* No prior treatment with cytotoxics in the advanced disease setting.
* HER2/neu positive disease unless trastuzumab was previously received or is contraindicated.
* Treatment with a taxane in the adjuvant setting unless disease free interval \>12 months after end of treatment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

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

Bessemer, Alabama, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Daphne, Alabama, United States

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Mobile, Alabama, United States

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Mobile, Alabama, United States

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Flagstaff, Arizona, United States

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Sedona, Arizona, United States

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Hot Springs, Arkansas, United States

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Anaheim, California, United States

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Antioch, California, United States

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Antioch, California, United States

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Baldwin Park, California, United States

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Bellflower, California, United States

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Fontana, California, United States

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Fountain Valley, California, United States

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Gilroy, California, United States

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Hawthorne, California, United States

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Hayward, California, United States

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Irvine, California, United States

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La Jolla, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Martinez, California, United States

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Milpitas, California, United States

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Modesto, California, United States

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Mountain View, California, United States

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Oakland, California, United States

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Ontario, California, United States

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Orange, California, United States

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Oxnard, California, United States

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Panorama City, California, United States

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Pinole, California, United States

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Riverside, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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San Francisco, California, United States

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San Francisco, California, United States

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San Jose, California, United States

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San Sacramento, California, United States

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Santa Clara, California, United States

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Santa Monica, California, United States

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Union City, California, United States

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Vallejo, California, United States

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Walnut Creek, California, United States

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Woodland Hills, California, United States

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Aurora, Colorado, United States

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Boulder, Colorado, United States

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Colorado Springs, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Lakewood, Colorado, United States

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Littleton, Colorado, United States

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Lone Tree, Colorado, United States

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Longmont, Colorado, United States

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Parker, Colorado, United States

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Thornton, Colorado, United States

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Norwalk, Connecticut, United States

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Boca Raton, Florida, United States

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Coral Springs, Florida, United States

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Davie, Florida, United States

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Hollywood, Florida, United States

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Inverness, Florida, United States

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Lakeland, Florida, United States

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Melbourne, 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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Orlando, Florida, United States

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Pembroke Pines, Florida, United States

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Tampa, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Columbus, Georgia, United States

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Decatur, Georgia, United States

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Macon, Georgia, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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Harvey, Illinois, United States

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Skokie, Illinois, United States

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Tinley Park, Illinois, United States

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Vernon Hills, Illinois, United States

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Avon, Indiana, United States

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Beech Grove, Indiana, United States

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Carmel, Indiana, United States

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Fishers, Indiana, United States

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Greenfield, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Indianapolis, Indiana, United States

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Jeffersonville, Indiana, United States

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Mooresville, Indiana, United States

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Munster, Indiana, United States

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New Albany, Indiana, United States

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Kansas City, Kansas, United States

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Overland Park, Kansas, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Annapolis, Maryland, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Randallstown, Maryland, United States

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Burlington, Massachusetts, United States

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Peabody, Massachusetts, United States

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Coon Rapids, Minnesota, United States

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Robbinsdale, Minnesota, United States

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Ocean Springs, Mississippi, United States

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Pascagoula, Mississippi, United States

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Columbia, Missouri, United States

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Kansas City, Missouri, United States

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Kansas City, Missouri, United States

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Kansas City, Missouri, United States

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Lee's Summit, Missouri, United States

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Fremont, Nebraska, United States

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Grand Island, Nebraska, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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Lincoln, Nebraska, United States

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Henderson, Nevada, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Albuquerque, New Mexico, United States

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Albuquerque, New Mexico, United States

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Buffalo, New York, United States

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Corning, New York, United States

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Jamaica, New York, United States

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Mineola, New York, United States

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Cary, North Carolina, United States

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Clinton, North Carolina, United States

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Durham, North Carolina, United States

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Goldsboro, North Carolina, United States

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Hickory, North Carolina, United States

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Kenansville, North Carolina, United States

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Kinston, North Carolina, United States

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Lenoir, North Carolina, United States

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Pollocksville, North Carolina, United States

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Raleight, North Carolina, United States

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Raliegh, North Carolina, United States

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Richlands, North Carolina, United States

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Washington, North Carolina, United States

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Wilson, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Canton, Ohio, United States

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Dover, Ohio, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Springfield, Oregon, United States

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Tualatin, Oregon, United States

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Allentown, Pennsylvania, United States

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Bethlehem, Pennsylvania, United States

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Ephrata, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Kingston, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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Charleston, South Carolina, United States

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Easley, South Carolina, United States

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Greenville, South Carolina, United States

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Greenville, South Carolina, United States

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Seneca, South Carolina, United States

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Spartanburg, South Carolina, United States

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Bristol, Tennessee, United States

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Kingsport, Tennessee, United States

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Amarillo, Texas, United States

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Antonio, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Bedford, Texas, United States

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Corpus Christi, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Fort Worth, Texas, United States

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Fort Worth, Texas, United States

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Forth Worth, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Kerrville, Texas, United States

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Longview, Texas, United States

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Midland, Texas, United States

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Round Rock, Texas, United States

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Round Rock, Texas, United States

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Round Rock, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Marcos, Texas, United States

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Shenandoah, Texas, United States

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Tyler, Texas, United States

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Waco, Texas, United States

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Ogden, Utah, United States

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Arlington, Virginia, United States

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Christiansburg, Virginia, United States

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Fairfax, Virginia, United States

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Leesburg, Virginia, United States

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Norton, Virginia, United States

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Roanoke, Virginia, United States

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Salem, Virginia, United States

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Woodbridge, Virginia, United States

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Wytheville, Virginia, United States

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Federal Way, Washington, United States

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Kennewick, Washington, United States

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Lakewood, Washington, United States

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Moses Lake, Washington, United States

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Puyallup, Washington, United States

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Tacoma, Washington, United States

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Vancouver, Washington, United States

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Vancouver, Washington, United States

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Wenatchee, Washington, United States

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Huntington, West Virginia, United States

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Morgantown, West Virginia, United States

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Berlin, , Germany

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Hamburg, , Germany

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Trier, , Germany

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Cremona, , Italy

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Grosseto, , Italy

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Olbia, , Italy

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Cabueñes, Gijon, Spain

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Guadalajara, Guadalajara, Spain

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Madrid, Madrid, Spain

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Countries

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Puerto Rico United States Germany Italy Spain

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6181094&StudyName=A%20Study%20Of%20SU011248%20Plus%20Paclitaxel%20Versus%20Bevacizumab%20Plus%20Paclitaxel%20In%20Patients%20With%20Advanced%20Breast%20Cancer

To obtain contact information for a study center near you, click here.

Other Identifiers

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A6181094

Identifier Type: -

Identifier Source: org_study_id