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 |
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.
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
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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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
Port Saint Lucie, Florida 34952
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Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Charleston, South Carolina 29425
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1190 East Newport Center Drive
Deerfield Beach, Florida 33442
Deerfield Beach, Florida 33442
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
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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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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1901 South 2nd Street
McAllen, Texas 78503
McAllen, Texas 78503
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Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Philadelphia, Pennsylvania 19106
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2013 Jefferson Street Southwest
Roanoke, Virginia 24014
Roanoke, Virginia 24014
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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
Tacoma, Washington 98405
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