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Completed Phase 3 Interventional Results available

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

ClinicalTrials.gov ID: NCT01663727

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.

ClinicalTrials.gov public records Last synced Oct 24, 2026, 1:36 AM EDT

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
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
481 participants

Conditions and interventions

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 27, 2012 (Actual)
Primary completion
Nov 30, 2014 (Actual)
Completion
Nov 21, 2017 (Actual)
Last update posted
Jan 22, 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.

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 22, 2019 · Synced Oct 24, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01663727 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →