A Trial of Paclitaxel and Bevacizumab vs. Gemcitabine, Paclitaxel, and Bevacizumab in Advanced Breast Cancer
NCT ID: NCT00320541
Last Updated: 2013-07-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
187 participants
INTERVENTIONAL
2006-05-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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paclitaxel plus bevacizumab (PB)
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
paclitaxel
90 mg/m2, IV, day 1, day 8 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
bevacizumab
10 mg/kg, IV, day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
paclitaxel plus bevacizumab plus gemcitabine (PB+G)
paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
gemcitabine
1500 mg/m2, IV day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
paclitaxel
90 mg/m2, IV, day 1, day 8 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
bevacizumab
10 mg/kg, IV, day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
Interventions
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gemcitabine
1500 mg/m2, IV day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
paclitaxel
90 mg/m2, IV, day 1, day 8 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
bevacizumab
10 mg/kg, IV, day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be able to measure the disease by specific medical parameters
* May have received breast cancer treatment in the early stage of the disease
* May be restricted in physically strenuous activity but able to carry out light work.
* Must have adequate organ function as seen in blood test results.
Exclusion
Criteria:
* Cancer that has spread to the brain.
* Unstable heart problems
* Unstable high blood pressure.
* Breast cancer treatment after the disease has considered to spread to other areas or organs.
* Unable to agree with the requirements of the study
18 Years
FEMALE
No
Sponsors
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Genentech, Inc.
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fayetteville, Arkansas, United States
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La Jolla, California, United States
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Mission Hills, California, United States
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Santa Rosa, California, United States
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Denver, Colorado, United States
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Fort Myers, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Springfield, Illinois, United States
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Muncie, Indiana, United States
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Lexington, Kentucky, United States
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Southfield, Michigan, United States
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Chesterfield, Missouri, United States
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Missoula, Montana, United States
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Akron, Ohio, United States
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Dayton, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Dunmore, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Dallas, Texas, United States
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Lubbock, Texas, United States
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Richmond, Virginia, United States
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Everett, Washington, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Ponce, , Puerto Rico
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San Juan, , Puerto Rico
Countries
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Other Identifiers
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B9E-US-S377
Identifier Type: OTHER
Identifier Source: secondary_id
10663
Identifier Type: -
Identifier Source: org_study_id
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