Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/23/2019
Start Date:August 27, 2012
End Date:November 21, 2017

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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate the Efficacy and Safety Of Bevacizumab, and Associated Biomarkers, In Combination With Paclitaxel Compared With Paclitaxel Plus Placebo as First-line Treatment Of Patients With Her2-Negative Metastatic Breast Cancer

This is a Phase III, randomized, double-blind, placebo-controlled multicenter study to
evaluate the efficacy and safety of bevacizumab administered in combination with paclitaxel
in patients with previously untreated, locally recurrent, or metastatic HER2-negative breast
cancer. Patients will be randomized to one of two treatment arms: bevacizumab or placebo. All
patients will be given an intravenous (IV) infusion of of paclitaxel (90 mg/m2) for 3 weeks
during each 28-day cycle. bevacizumab or placebo (10 mg/kg) will be administered by IV
infusion on Days 1 and 15 of each 28-day cycle. Patients will be treated until disease
progression, unacceptable toxicity or death from any cause occurs.


Inclusion Criteria:

- Histologically or cytologically confirmed, HER2-negative adenocarcinoma of the breast,
with measurable or non-measurable locally recurrent or metastatic disease. Locally
recurrent disease must not be amenable to resection with curative intent.

- ECOG performance status of 0 or 1

- For women of childbearing potential, use of an acceptable and effective method of
non-hormonal contraception

- For patients who have received recent radiotherapy, recovery prior to randomization
from any significant acute toxicity, and radiation treatments have to be completed
more than 3 weeks from randomization

Exclusion Criteria:

Disease-Specific Exclusions:

- HER2-positive status

- Prior chemotherapy for locally recurrent or metastatic disease

- Prior hormonal therapy < 2 weeks prior to randomization

- Prior adjuvant or neo-adjuvant chemotherapy is allowed, provided its conclusion has
been for at least 12 months prior to randomization

- Investigational therapy within 28 days of randomization

General Medical Exclusions:

- Life expectancy of < 12 weeks

- Inadequate organ function

- Uncontrolled serious medical or psychiatric illness

- Active infection requiring intravenous (IV) antibiotics at screening

- Pregnancy or lactation

- History of other malignancies within 5 years prior to screening, except for tumors
with a negligible risk for metastasis or death
We found this trial at
66
sites
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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1871 SE Tiffany Ave # 100
Port Saint Lucie, Florida 34952
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Alexandria, Virginia 22304
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Athens, Georgia 30607
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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410 Stagecoach Road
Bristol, Virginia 24201
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Burlington, Massachusetts 01805
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Chesapeake, Virginia 23320
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Ciudad Autonoma Buenos Aires,
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Columbia, Maryland 21044
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Columbia, Missouri 65201
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Corona, California 92879
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1190 East Newport Center Drive
Deerfield Beach, Florida 33442
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Fort Myers, Florida 33905
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Fort Worth, Texas 76104
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Fort Worth, Texas 76132
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Gainesville, Virginia 20155
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Garland, Texas
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Glendora, California 91741
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hampton, Virginia 23666
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Honolulu, HI
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Indianapolis, Indiana 46202
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Kerrville, Texas 78028
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La Verne, California 91750
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Leesburg, Pennsylvania 20176
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701 East 28th Street
Long Beach, California 90806
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Longview, TX
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1901 South 2nd Street
McAllen, Texas 78503
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Morgantown, West Virginia 26506
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Nashville, Tennessee 37203
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New Albany, Mississippi 38652
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Newport News, Virginia 23606
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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555 East Tachevah Drive
Palm Springs, California 92262
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Plano, Texas 75093
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Plantation, Florida 33322
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Rancho Cucamonga, California 91730
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2013 Jefferson Street Southwest
Roanoke, Virginia 24014
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2013 Jefferson Street Southwest
Salem, Virginia 24014
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San Antonio, Texas 78258
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100 NE Loop 410; Suite 600
San Antonio, Texas 78216
210-424-1600
Cancer Care Centers of South Texas At Cancer Care Centers of South Texas, we are...
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1624 South I Street
Tacoma, Washington 98405
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The Woodlands, Texas 77060
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The Woodlands, Texas 77381
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Tucson, Arizona
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Virginia Beach, Virginia 23456
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Washington, District of Columbia 20010
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West Covina, California 91790
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