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
Public ClinicalTrials.gov record NCT01663727. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01663727
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 481 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 26, 2012
- Primary completion
- Nov 29, 2014
- Completion
- Nov 20, 2017
- Last update posted
- Jan 21, 2019
2012 – 2017
United States locations
- U.S. sites
- 66
- U.S. states
- 21
- U.S. cities
- 61
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| Arizona Cancer Center | Tucson | Arizona | 85724 | — |
| Wilshire Oncology Medical Group | Corona | California | 92879 | — |
| Wilshire Oncology Medical Group | Glendora | California | 91741 | — |
| Wilshire Oncology Medical Group | La Verne | California | 91750 | — |
| Long Beach Memorial Medical Center; Oncology | Long Beach | California | 90806 | — |
| Tenet Health System Desert Inc | Palm Springs | California | 92262 | — |
| Wilshire Oncology Medical Group; Oncology | Pomona | California | 91767 | — |
| Wilshire Oncology Medical Group | Rancho Cucamonga | California | 91730 | — |
| Wilshire Oncology Medical Group | West Covina | California | 91790 | — |
| Washington Hospital | Washington D.C. | District of Columbia | 20010 | — |
| Sylvester Comprehensive Cancer Center - Deerfield Beach; Sylvester Cancer Center | Deerfield Beach | Florida | 33442 | — |
| Florida Cancer Specialists - Broadway | Fort Myers | Florida | 33901 | — |
| BRCR Medical Center, Inc. | Plantation | Florida | 33322 | — |
| Hematology Oncology Associates of the Treasure Coast | Port Saint Lucie | Florida | 34952 | — |
| Northeast Georgia Cancer Care LLC | Athens | Georgia | 30607 | — |
| Peachtree Hematology & Oncology Consultants, Pc | Atlanta | Georgia | 30318 | — |
| Kaiser Foundation Hospital; Dr. Eron's Office | Honolulu | Hawaii | 96819 | — |
| IU Cancer Pavilion | Indianapolis | Indiana | 46202 | — |
| Greater Baltimore Medical Center | Baltimore | Maryland | 21204 | — |
| Maryland Oncology Hematology, P.A. | Columbia | Maryland | 21044 | — |
| Lahey Clinic Inc. - PARENT ACCOUNT | Burlington | Massachusetts | 01805 | — |
| The Jones Clinic, PC | New Albany | Mississippi | 38652 | — |
| Missouri Cancer Associates | Columbia | Missouri | 65201 | — |
| Washington University; Center for Adv Medicine | St Louis | Missouri | 63110 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Signal Point Clinical; Research Center, LLC | Middletown | Ohio | 45042 | — |
| ProMedica Hickman Cancer Center at Flower Hospital; Hickman Cancer Center | Sylvania | Ohio | 43560 | — |
| University of Toledo; Dept. of Medicine | Toledo | Ohio | 43614 | — |
| Virginia Cancer Specialists - Leesburg | Leesburg | Pennsylvania | 20176 | — |
| Pennsylvania Oncology Hematology Associates, Inc.; PA Oncology & Hematology | Philadelphia | Pennsylvania | 19106 | — |
| Medical University of South Carolina; Division of Hematology-Oncology | Charleston | South Carolina | 29425 | — |
| SCRI-Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Texas Oncology-Medical City Dallas | Dallas | Texas | 75230 | — |
| Texas Oncology, P.A. - Dallas Presbyterian | Dallas | Texas | 75231 | — |
| Texas Oncology, P.A. - Fort Worth | Fort Worth | Texas | 76104 | — |
| Texas Oncology- Southwest Fort Worth | Fort Worth | Texas | 76132 | — |
| Univ of Texas Medical Branch | Galveston | Texas | 77555 | — |
| Texas Oncology, P.A. - Garland | Garland | Texas | 77060 | — |
| Cancer Care Centers of S Texas | Kerrville | Texas | 78028 | — |
| Texas Oncology- Longview Cancer Center | Longview | Texas | 75601 | — |
| Texas Oncology, P.A. - McAllen; South Texas Cancer Center-McAllen | McAllen | Texas | 78503 | — |
| Texas Oncology Plano West | Plano | Texas | 75093 | — |
| Cancer Care Centers of South Texas | San Antonio | Texas | 78212 | — |
| Cancer Care Centers of South Texas | San Antonio | Texas | 78217 | — |
| CancerCare Centers of South Texas | San Antonio | Texas | 78258 | — |
| Texas Oncology, P.A. - Tyler | The Woodlands | Texas | 77060 | — |
| Texas Oncology, P.A. | The Woodlands | Texas | 77060 | — |
| Virginia Cancer Specialists - Alexandria | Alexandria | Virginia | 22304 | — |
| Fairfax Northern Virginia Hematology-Oncology PC | Arlington | Virginia | 22205 | — |
| Wellmonth Physician Services | Bristol | Virginia | 24201 | — |
| Virginia Oncology Associates - Chesapeake | Chesapeake | Virginia | 23320 | — |
| Oncology & Hematology Associates of SW Va Inc. - Market Street | Christiansburg | Virginia | 24073 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Hematology Oncology Associates of Fredericksburg, Inc. | Fredericksburg | Virginia | 22408 | — |
| Virginia Cancer Specialists - Gainsville | Gainesville | Virginia | 20155 | — |
| Virginia Oncology Associates - Hampton | Hampton | Virginia | 23666 | — |
| Oncology and Hematology Assoc. of SW VA, Inc. - Low Moor | Low Moor | Virginia | 24457 | — |
| Virginia Oncology Associates - New Port News | Newport News | Virginia | 23606 | — |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | — |
| Oncology & Hematolgy Associates of SW Va Inc. - Roanoke | Roanoke | Virginia | 24014 | — |
| Oncology and Hematology Assoc. of SW VA, Inc. | Salem | Virginia | 77060 | — |
| Virginia Oncology Associates - Virginia Beach | Virginia Beach | Virginia | 23456 | — |
| Oncology and Hematology Assoc. of SW VA, Inc. - Wytheville | Wytheville | Virginia | 24382 | — |
| Northwest Medical Specialties, PLLC; Research Department | Tacoma | Washington | 98405 | — |
| West Virginia University; Endocrinology | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 112 non-U.S. sites.
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About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01663727, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 21, 2019 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01663727 live on ClinicalTrials.gov.