Study Stopped
Closed early due to slow accrual
Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU
A Randomized Phase III Double-Blind Placebo-Controlled Trial of First-Line Chemotherapy and Trastuzumab With or Without Bevacizumab for Patients With HER-2/NEU Over-Expressing Metastatic Breast Cancer
4 other identifiers
interventional
96
1 country
373
Brief Summary
This randomized phase III trial studies first-line chemotherapy and trastuzumab to compare how well they work when given with or without bevacizumab in treating patients with breast cancer that overexpresses human epidermal growth factor receptor 2 (HER-2/NEU) and has spread to other areas of the body. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as trastuzumab and bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking the growth of new blood vessels necessary for tumor growth. It is not yet known whether giving first-line chemotherapy together with trastuzumab is more effective with or without bevacizumab in treating patients with metastatic breast cancer that overexpresses HER-2/NEU.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2007
Longer than P75 for phase_3
373 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 24, 2007
CompletedFirst Posted
Study publicly available on registry
August 27, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedResults Posted
Study results publicly available
November 29, 2016
CompletedMarch 28, 2025
December 1, 2016
7.9 years
August 24, 2007
October 5, 2016
March 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
Progression-free survival (PFS) was defined as time from date of randomization to first disease progression, new second breast primaries, or to death from any cause, whichever occurred first, otherwise cases were censored at date last documented to be free of progression. Disease progression was defined using the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.0, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Kaplan-Meier method was used to estimate the median PFS.
assessed every 3 months for patients within 2 years of registration, every 6 months for patients 3-5 years from registration and then yearly for up to10 years
Secondary Outcomes (4)
Overall Survival
assessed every 3 months for patients within 2 years of registration, every 6 months for patients 3-5 years from registration and then yearly for up to10 years
Proportion of Progression-free at 6 Months
assessed at baseline, at 3 and 6 months after study entry
Overall Response Rate
assessed at baseline, every 12 weeks while on treatment, then very 3 months if patient is <2 years from study entry, every 6 months if 2-5 years from study entry, and annually if 6-10 years from study entry until disease progression
Number of Patients Experiencing Congestive Heart Failure
assessed every 3 months while on treatment and at 3 months post treatment
Other Outcomes (6)
Change in Fatigue Level Between Baseline and Cycle 6 Induction
assessed at baseline and at cycle 6 induction prior to starting maintenance therapy
Change in FACT/NCCN Breast Symptom Index (FBSI) Between Baseline and Cycle 6 Induction
assessed at baseline and at cycle 6 induction prior to starting maintenance therapy
Change in Neurotoxicity Level Between Baseline and Cycle 6 Induction
assessed at baseline and at cycle 6 induction prior to starting maintenance therapy
- +3 more other outcomes
Study Arms (2)
Arm A (chemotherapy and placebo)
ACTIVE COMPARATORINDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Arm B (chemotherapy and bevacizumab)
EXPERIMENTALINDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Histologically confirmed breast cancer that overexpresses HER-2/NEU with evidence of metastatic disease and/or chest wall recurrence prior to randomization
- HER-2/NEU overexpression is defined as 3+ HER-2 positivity as measured by immunohistochemistry OR HER-2 gene amplification as measured by fluorescent in situ hybridization (FISH, e.g. Vysis), per American Society of Clinical Oncology guidelines
- NOTE: representative diagnostic tissue must be submitted for central diagnostic review for confirmation of HER-2/NEU overexpression within two weeks following patient randomization
- Evaluable (measurable or non-measurable) disease is allowed if confirmed within 4 weeks prior to randomization
- Prior endocrine treatment in the adjuvant or metastatic setting is allowed, provided last dose given \>= 2 weeks prior to randomization
- Radiation therapy is allowed provided last dose is given \>= 3 weeks prior to randomization
- Adjuvant trastuzumab therapy for breast cancer is allowed provided last dose was given \>= 12 months prior to diagnosis of recurrence
- Adjuvant or neoadjuvant taxane therapy for breast cancer is allowed provided last dose was given \>= 12 months prior to diagnosis of recurrence
- Adjuvant or neoadjuvant therapy with lapatinib is allowed provided last dose is given \>= 4 weeks prior to diagnosis of recurrence
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute neutrophil count \>= 1,000/mm\^3
- Platelet count \>= 100,000/mm\^3
- Total bilirubin =\< 1.5 mg/dL
- Aspartate aminotransferase (AST) =\< 2 times upper limit of normal (ULN) (=\< 5 times normal in patients with known liver involvement)
- Serum creatinine =\< 1.5 mg/dL
- +11 more criteria
You may not qualify if:
- Prior chemotherapy, trastuzumab, or bevacizumab for metastatic breast cancer
- Patients who have had a cumulative dose of doxorubicin of greater than 360 mg/m\^2 or epirubicin of greater than 640 mg/m\^2 in the adjuvant or neo-adjuvant setting at any time
- Patients with grade 2-4 neuropathy
- Patients with a history or radiologic evidence of central nervous system (CNS) disease
- Patients have a current non-healing wound or fracture
- Patients have a hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products or other recombinant human antibodies
- Patients have a serious medical or psychiatric illness that would prevent ability to safely participate or provide informed consent
- Patients using any of the following drugs known to inhibit platelet function are not eligible: dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and cilostazol (Pletal)
- Clinically significant cardiovascular disease, including:
- History of cerebrovascular (CVA) within 6 months
- Uncontrolled hypertension
- Myocardial infarction or unstable angina within 6 months
- New York Heart Association class II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, unstable angina pectoris
- Clinically significant peripheral vascular disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (373)
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, 72401, United States
East Bay Radiation Oncology Center
Castro Valley, California, 94546, United States
Eden Hospital Medical Center
Castro Valley, California, 94546, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, 94546, United States
Bay Area Breast Surgeons Inc
Emeryville, California, 94608, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, 94538, United States
Saint Rose Hospital
Hayward, California, 94545, United States
Contra Costa Regional Medical Center
Martinez, California, 94553-3156, United States
Fremont - Rideout Cancer Center
Marysville, California, 95901, United States
Community Hospital of Monterey Peninsula
Monterey, California, 93940, United States
El Camino Hospital
Mountain View, California, 94040, United States
Highland General Hospital
Oakland, California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609, United States
Bay Area Tumor Institute
Oakland, California, 94609, United States
Hematology and Oncology Associates-Oakland
Oakland, California, 94609, United States
Tom K Lee Inc
Oakland, California, 94609, United States
Valley Care Health System - Pleasanton
Pleasanton, California, 94588, United States
Valley Medical Oncology Consultants
Pleasanton, California, 94588, United States
Pomona Valley Hospital Medical Center
Pomona, California, 91767, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, 94806, United States
The Medical Center of Aurora
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Exempla Saint Joseph Hospital
Denver, Colorado, 80218, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
Colorado Cancer Research Program NCORP
Denver, Colorado, 80222, United States
Swedish Medical Center
Englewood, Colorado, 80113, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81502, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Saint Anthony Hospital
Lakewood, Colorado, 80228, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Longmont United Hospital
Longmont, Colorado, 80501, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Emory University/Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Memorial University Medical Center
Savannah, Georgia, 31404, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405, United States
Queen's Medical Center
Honolulu, Hawaii, 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, 96817, United States
Portneuf Medical Center
Pocatello, Idaho, 83201, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
MacNeal Hospital and Cancer Center
Berwyn, Illinois, 60402, United States
Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704, United States
Graham Hospital Association
Canton, Illinois, 61520, United States
Illinois CancerCare-Canton
Canton, Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage, Illinois, 62321, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
Hematology and Oncology Associates
Chicago, Illinois, 60611, United States
Northwestern University
Chicago, Illinois, 60611, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612-3785, United States
University of Illinois
Chicago, Illinois, 60612, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Heartland Cancer Research NCORP
Decatur, Illinois, 62526, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
Illinois CancerCare-Eureka
Eureka, Illinois, 61530, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, 60201, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
Illinois CancerCare Galesburg
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Cottage
Galesburg, Illinois, 61401, United States
Ingalls Memorial Hospital
Harvey, Illinois, 60426, United States
Illinois CancerCare-Havana
Havana, Illinois, 62644, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, 60035, United States
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, 60521, United States
Hopedale Medical Complex - Hospital
Hopedale, Illinois, 61747, United States
Midwest Center for Hematology Oncology
Joliet, Illinois, 60432, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, 60435, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, 61443, United States
NorthShore Hematology Oncology-Libertyville
Libertyville, Illinois, 60048, United States
Illinois CancerCare-Macomb
Macomb, Illinois, 61455, United States
Mcdonough District Hospital
Macomb, Illinois, 61455, United States
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, 61265, United States
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, 61265, United States
Sharis, Christine M MD (UIA Investigator)
Moline, Illinois, 61265, United States
Spector, David MD (UIA Investigator)
Moline, Illinois, 61265, United States
Stoffel, Thomas J MD (UIA Investigator)
Moline, Illinois, 61265, United States
Holy Family Medical Center
Monmouth, Illinois, 61462, United States
Illinois CancerCare-Monmouth
Monmouth, Illinois, 61462, United States
Edward Hospital/Cancer Center
Naperville, Illinois, 60540, United States
DuPage Medical Group-Ogden
Naperville, Illinois, 60563, United States
Illinois Cancer Specialists-Niles
Niles, Illinois, 60714, United States
Bromenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center Foundation
Normal, Illinois, 61761, United States
Illinois CancerCare-Community Cancer Center
Normal, Illinois, 61761, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554, United States
Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
Pekin Hospital
Pekin, Illinois, 61554, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61603, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois CancerCare-Peru
Peru, Illinois, 61354, United States
Illinois Valley Hospital
Peru, Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton, Illinois, 61356, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, 60076, United States
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, 61362, United States
Saint Margaret's Hospital
Spring Valley, Illinois, 61362, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Carle Clinic-Urbana Main
Urbana, Illinois, 61801, United States
Franciscan St. Francis Health-Beech Grove
Beech Grove, Indiana, 46107, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
Saint Vincent Hospital and Health Care Center
Indianapolis, Indiana, 46260, United States
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
IU Health La Porte Hospital
La Porte, Indiana, 46350, United States
IU Health Arnett Cancer Care
Lafayette, Indiana, 47904, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
Reid Hospital and Health Care Services
Richmond, Indiana, 47374, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
Northern Indiana Cancer Research Consortium CCOP
South Bend, Indiana, 46628, United States
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, 50010, United States
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, 52722, United States
Genesis Medical Center - East Campus
Davenport, Iowa, 52803, United States
Genesis Medical Center - West Campus
Davenport, Iowa, 52804, United States
Mercy Capitol
Des Moines, Iowa, 50307, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51104, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Covenant Medical Center
Waterloo, Iowa, 50702, United States
Hospital District Sixth of Harper County
Anthony, Kansas, 67003, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Stormont-Vail Regional Health Center
Topeka, Kansas, 66604, United States
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, 66606, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas - Main Office
Wichita, Kansas, 67214, United States
Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Wichita NCI Community Oncology Research Program
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70806, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Interim LSU Public Hospital
New Orleans, Louisiana, 70112, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
York Hospital
York Village, Maine, 03909, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Memorial Hospital at Easton - Shore Regional Cancer Center
Easton, Maryland, 21601, United States
The Memorial Hospital at Easton
Easton, Maryland, 21601, United States
Bixby Medical Center
Adrian, Michigan, 49221, United States
Hickman Cancer Center
Adrian, Michigan, 49221, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, 48106-0995, United States
Michigan Cancer Research Consortium CCOP
Ann Arbor, Michigan, 48106, United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, 48124, United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Saint John Hospital and Medical Center
Detroit, Michigan, 48236, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, 49431, United States
Hurley Medical Center
Flint, Michigan, 48502, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, 49801, United States
Allegiance Health
Jackson, Michigan, 49201, United States
Sparrow Hospital
Lansing, Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia, Michigan, 48154, United States
Mercy Memorial Hospital
Monroe, Michigan, 48162, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, 48162, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, 48341, United States
Saint Joseph Mercy Port Huron
Port Huron, Michigan, 48060, United States
Saint Mary's of Michigan
Saginaw, Michigan, 48601, United States
Lakeland Hospital
Saint Joseph, Michigan, 49085, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, 48093, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Fairview-Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Meeker County Memorial Hospital
Litchfield, Minnesota, 55355, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Saint Joseph's Hospital - Healtheast
Saint Paul, Minnesota, 55102, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Woodwinds Health Campus
Woodbury, Minnesota, 55125, United States
Southeast Missouri Hospital
Cape Girardeau, Missouri, 63701, United States
Capital Regional Medical Center
Jefferson City, Missouri, 65101, United States
Mercy Hospital-Joplin
Joplin, Missouri, 64804, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, 65804, United States
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Center for Cancer Care and Research
St Louis, Missouri, 63141, United States
Montana Cancer Consortium NCORP
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Frontier Cancer Center and Blood Institute-Billings
Billings, Montana, 59102, United States
Billings Clinic Cancer Center
Billings, Montana, 59107, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Northern Montana Hospital
Havre, Montana, 59501, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Glacier Oncology PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Community Medical Hospital
Missoula, Montana, 59801, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804, United States
CHI Health Good Samaritan
Kearney, Nebraska, 68847, United States
Portsmouth Regional Hospital
Portsmouth, New Hampshire, 03802, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Overlook Hospital
Summit, New Jersey, 07902, United States
Inspira Medical Center Vineland
Vineland, New Jersey, 08360, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Orange Regional Medical Center
Middletown, New York, 10940, United States
Interlakes Foundation Inc-Rochester
Rochester, New York, 14623, United States
University of Rochester
Rochester, New York, 14642, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467-2490, United States
Mission Hospital-Memorial Campus
Asheville, North Carolina, 28801, United States
Cape Fear Valley Health System
Fayetteville, North Carolina, 28304, United States
Gaston Memorial Hospital
Gastonia, North Carolina, 28054, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Mid Dakota Clinic
Bismarck, North Dakota, 58501, United States
Saint Alexius Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Mary Rutan Hospital
Bellefontaine, Ohio, 43311, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, 43402, United States
Mercy Medical Center
Canton, Ohio, 44708, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
North Coast Cancer Care-Clyde
Clyde, Ohio, 43410, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Columbus NCI Community Oncology Research Program
Columbus, Ohio, 43215, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Health Center
Dayton, Ohio, 45415, United States
Dayton NCI Community Oncology Research Program
Dayton, Ohio, 45420, United States
Veteran Affairs Medical Center
Dayton, Ohio, 45428, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Hematology Oncology Center Incorporated
Elyria, Ohio, 44035, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Saint Luke's Hospital
Maumee, Ohio, 43537, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, 43537, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, 43537, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Saint Charles Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, 43616, United States
North Coast Cancer Care
Sandusky, Ohio, 44870, United States
Springfield Regional Medical Center
Springfield, Ohio, 45505, United States
Flower Hospital
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, 43606, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
University of Toledo
Toledo, Ohio, 43614, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, 43617, United States
Mercy Saint Anne Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, 43623, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Clinton Memorial Hospital
Wilmington, Ohio, 45177, United States
Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
Cancer Care Associates
Oklahoma City, Oklahoma, 73120, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, 97222, United States
Providence Portland Medical Center
Portland, Oregon, 97213, United States
Western Oncology Research Consortium
Portland, Oregon, 97213, United States
Adventist Medical Center
Portland, Oregon, 97216, United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225, United States
Doylestown Hospital
Doylestown, Pennsylvania, 18901, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, 19464, United States
Penn State Health Saint Joseph Medical Center
Reading, Pennsylvania, 19605, United States
Grand View Hospital
Sellersville, Pennsylvania, 18960, United States
Hematology and Oncology Associates of Rhode Island Inc
Cranston, Rhode Island, 02920, United States
Kent County Hospital
Warwick, Rhode Island, 02886, United States
Avera Saint Luke's Hospital and Cancer Center
Aberdeen, South Dakota, 57401, United States
Erlanger Medical Center
Chattanooga, Tennessee, 37403, United States
University of Tennessee Health Science Center
Memphis, Tennessee, 38163, United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232, United States
Zale Lipshy University Hospital
Dallas, Texas, 75235, United States
Clements University Hospital
Dallas, Texas, 75390, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390, United States
Scott and White Memorial Hospital
Temple, Texas, 76508, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, 22401, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, 98310, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Minor and James Medical PLLC
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Group Health Cooperative-Seattle
Seattle, Washington, 98112, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307, United States
The Polyclinic
Seattle, Washington, 98122, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, 98664, United States
West Virginia University Charleston
Charleston, West Virginia, 25304, United States
West Virginia University Healthcare
Morgantown, West Virginia, 26506, United States
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, 26101, United States
Langlade Hospital and Cancer Center
Antigo, Wisconsin, 54409, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, 54701, United States
Sacred Heart Hospital
Eau Claire, Wisconsin, 54701, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
Saint Vincent Hospital
Green Bay, Wisconsin, 54301, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, 53038, United States
Dean Hematology and Oncology Clinic
Madison, Wisconsin, 53717, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Saint Joseph's Hospital
Marshfield, Wisconsin, 54449, United States
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, 54501, United States
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, 54868, United States
Saint Michael's Hospital
Stevens Point, Wisconsin, 54481, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Diagnostic and Treatment Center
Weston, Wisconsin, 54476, United States
Aspirus UW Cancer Center
Wisconsin Rapids, Wisconsin, 54494, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Related Publications (1)
Mezzanotte-Sharpe J, ONeill A, Mayer IA, Arteaga CL, Yang XJ, Wagner LI, Cella D, Meropol NJ, Alpaugh RK, Saphner TJ, Swaney RE, Hoelzer KL, Gradishar WJ, Abramson VG, Sundaram PK, Jilani SZ, Perez EA, Lin NU, Jahanzeb M, Wolff AC, Sledge GW, Reid SA. A randomized phase III double-blind placebo-controlled trial of first-line chemotherapy and trastuzumab with or without bevacizumab for patients with HER2/neu-positive metastatic breast cancer: a trial of the ECOG-ACRIN Cancer Research Group (E1105). Breast Cancer Res Treat. 2024 Sep;207(2):275-282. doi: 10.1007/s10549-024-07417-4. Epub 2024 Jul 5.
PMID: 38967884DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- ECOG-ACRIN statistician
- Organization
- ECOG-ACRIN Statistical Office
Study Officials
- PRINCIPAL INVESTIGATOR
Ingrid Mayer
ECOG-ACRIN Cancer Research Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2007
First Posted
August 27, 2007
Study Start
November 1, 2007
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
March 28, 2025
Results First Posted
November 29, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will share
Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.