First-Line Chemotherapy and Trastuzumab With or Without Bevacizumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER-2/NEU

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00520975
First received: August 24, 2007
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

This randomized phase III trial is studying first-line chemotherapy and trastuzumab to compare how well they work when given with or without bevacizumab in treating patients with metastatic breast cancer that overexpresses human epidermal growth factor receptor 2 (HER-2/NEU). 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 or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. 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.


Condition Intervention Phase
HER2-positive Breast Cancer
Male Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Biological: trastuzumab
Drug: paclitaxel
Drug: carboplatin
Other: placebo
Biological: bevacizumab
Other: laboratory biomarker analysis
Other: quality-of-life assessment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: From randomization to progression per RECIST, new second breast cancer primaries or to death from any cause without documentation of progression, whichever occurs first, assessed up to 10 years ] [ Designated as safety issue: No ]
    This primary comparison will be performed using a one-sided log rank test stratified using an overall type I error of 2.5%.


Secondary Outcome Measures:
  • Overall survival [ Time Frame: From randomization to death from any cause, assessed up to 10 years ] [ Designated as safety issue: No ]
    A truncated version of the Lan-Demets error spending rate function corresponding to the O'Brien-Fleming boundary will be used to control the overall type I error rate at a one-sided 0.025 level.

  • Quality of Life assessed using the Functional Assessment of Cancer Therapy (FACT)- Breast Symptom Index Questionnaire-8, FACT- General (G item GP5), FACT/Gynecologic Oncology Group-Neurotoxicity and FACT Fatigue [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
    The Wilcoxon Rank Sum test will be used to compare the arms if the distributions of scores are not normally distributed. Longitudinal modeling will be used to look at changes in the scores over time between arms.

  • Congestive heart failure (CHF) rate [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
    Using a Fisher's exact test and a 10% one sided type I error rate, there is 81% power to detect a difference of 4% vs. 10% CHF rate.

  • Change in CTC levels over time [ Time Frame: Baseline to up to 12 weeks after treatment initiation ] [ Designated as safety issue: No ]
    Fisher's exact test will be used to test for differences between treatment groups with respect to the proportion of patients with blood will less than 5 CTCs at baseline and at follow up timepoints.

  • VEGF levels in breast tumor by immunohistochemistry assay [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 489
Study Start Date: November 2007
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A (chemotherapy and placebo)

INDUCTION 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.

Biological: trastuzumab
Lead intervention, given IV
Other Names:
  • anti-c-erB-2
  • Herceptin
  • MOAB HER2
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Other: placebo
Given IV
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Experimental: Arm B (chemotherapy and bevacizumab)

INDUCTION 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.

Biological: trastuzumab
Lead intervention, given IV
Other Names:
  • anti-c-erB-2
  • Herceptin
  • MOAB HER2
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF
Other: laboratory biomarker analysis
Correlative studies
Other: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Prior chemotherapy, trastuzumab, or bevacizumab for metastatic breast cancer is not allowed
  • 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 are not allowed
  • 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
  • Patients with grade 2-4 neuropathy are not allowed
  • 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
  • Urine protein: creatinine ratio =< 0.5 OR 24-hour urine protein < 1000 mg
  • International normalized ratio (INR) =< 1.5 X ULN
  • Partial thromboplastin time (PTT) =< 1.5 X ULN
  • Multi gated acquisition scan (MUGA) scan or echocardiogram (ECHO) within 6 weeks prior to randomization with an left ventricular ejection fraction (LVEF) above the institutional lower limit of normal
  • Patients must be able to understand and provide signed and dated written informed consent
  • Patients with a history or radiologic evidence of central nervous system (CNS) disease are not allowed
  • Major surgical procedure within 4 weeks prior to randomization is not allowed (except for non-operative biopsy, which would not be considered major surgery); treatment can not begin until seven (7) days after placement of a vascular access device
  • Clinically significant cardiovascular disease is not allowed, 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
  • Women must not be pregnant or breastfeeding; all females of childbearing potential must have a blood or urine test within 2 weeks prior to randomization to rule out pregnancy; women of childbearing potential and sexually active males must use an accepted and effective method of contraception
  • Patients on full-dose anticoagulants (e.g., warfarin) with PT/INR > 1.5 may be eligible provided that both of the following criteria are met:

    • The patient has an in-range INR (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
    • The patient has not active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
  • Patients using any of the following drugs known to inhibit platelet function are not eligible: dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and cilostazol (Pletal)
  • Patients must not have a current non-healing wound or fracture
  • Patients must not have a hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products or other recombinant human antibodies
  • Patients must not have a serious medical or psychiatric illness that would prevent ability to safely participate or provide informed consent
  • Patients with a concurrent active malignancy except carcinoma in situ of the cervix or non-melanoma skin cancers (unless disease-free for at least 5 years at study entry) are not allowed
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520975

  Hide Study Locations
Locations
United States, Arkansas
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, United States, 72401
United States, California
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States, 94546
Eden Hospital Medical Center
Castro Valley, California, United States, 94546
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States, 94538
Saint Rose Hospital
Hayward, California, United States, 94545
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156
Fremont - Rideout Cancer Center
Marysville, California, United States, 95901
Community Hospital of Monterey Peninsula
Monterey, California, United States, 93940
El Camino Hospital
Mountain View, California, United States, 94040
Bay Area Breast Surgeons Inc
Oakland, California, United States, 94609
Bay Area Tumor Institute CCOP
Oakland, California, United States, 94609
Larry G Strieff MD Medical Corporation
Oakland, California, United States, 94609
Highland General Hospital
Oakland, California, United States, 94602
Tom K Lee Inc
Oakland, California, United States, 94609
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
Valley Medical Oncology Consultants
Pleasanton, California, United States, 94588
Valley Care Health System - Pleasanton
Pleasanton, California, United States, 94588
Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
University of California at Davis Cancer Center
Sacramento, California, United States, 95817
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, United States, 94806
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
Rose Medical Center
Denver, Colorado, United States, 80220
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Swedish Medical Center
Englewood, Colorado, United States, 80113
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
United States, Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, United States, 33136
United States, Georgia
Emory University/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Grady Health System
Atlanta, Georgia, United States, 30303
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
Saint Joseph's-Candler Health System
Savannah, Georgia, United States, 31405
United States, Hawaii
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States, 96817
University of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Idaho
Portneuf Medical Center
Pocatello, Idaho, United States, 83201
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
MacNeal Hospital and Cancer Center
Berwyn, Illinois, United States, 60402
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States, 61701
Graham Hospital Association
Canton, Illinois, United States, 61520
Illinois CancerCare-Canton
Canton, Illinois, United States, 61520
Illinois CancerCare-Carthage
Carthage, Illinois, United States, 62321
Memorial Hospital
Carthage, Illinois, United States, 62321
University of Illinois
Chicago, Illinois, United States, 60612
Northwestern University
Chicago, Illinois, United States, 60611
Hematology and Oncology Associates
Chicago, Illinois, United States, 60611
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Eureka Hospital
Eureka, Illinois, United States, 61530
Illinois CancerCare-Eureka
Eureka, Illinois, United States, 61530
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
Illinois CancerCare-Cottage
Galesburg, Illinois, United States, 61401
Illinois CancerCare Galesburg
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Illinois CancerCare-Havana
Havana, Illinois, United States, 62644
Mason District Hospital
Havana, Illinois, United States, 62644
Hematology Oncology Associates of Illinois-Highland Park
Highland Park, Illinois, United States, 60035
Hinsdale Hematology Oncology Associates Incorporated
Hinsdale, Illinois, United States, 60521
Hopedale Medical Complex - Hospital
Hopedale, Illinois, United States, 61747
Midwest Center for Hematology Oncology
Joliet, Illinois, United States, 60432
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States, 60435
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois, United States, 61443
North Shore Hematology Oncology
Libertyville, Illinois, United States, 60048
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Illinois CancerCare-Macomb
Macomb, Illinois, United States, 61455
Spector, David MD (UIA Investigator)
Moline, Illinois, United States, 61265
Sharis, Christine M MD (UIA Investigator)
Moline, Illinois, United States, 61265
Stoffel, Thomas J MD (UIA Investigator)
Moline, Illinois, United States, 61265
Porubcin, Michael MD (UIA Investigator)
Moline, Illinois, United States, 61265
Garneau, Stewart C MD (UIA Investigator)
Moline, Illinois, United States, 61265
Holy Family Medical Center
Monmouth, Illinois, United States, 61462
Illinois CancerCare-Monmouth
Monmouth, Illinois, United States, 61462
Edward Hospital/Cancer Center
Naperville, Illinois, United States, 60540
DuPage Medical Group-Ogden
Naperville, Illinois, United States, 60563
Illinois Cancer Specialists-Niles
Niles, Illinois, United States, 60714
Illinois CancerCare-Community Cancer Center
Normal, Illinois, United States, 61761
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Pekin Hospital
Pekin, Illinois, United States, 61554
Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Illinois CancerCare-Pekin
Pekin, Illinois, United States, 61554
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois CancerCare-Peru
Peru, Illinois, United States, 61354
Illinois Valley Hospital
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Illinois CancerCare-Princeton
Princeton, Illinois, United States, 61356
Hematology Oncology Associates of Illinois - Skokie
Skokie, Illinois, United States, 60076
Saint Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Illinois CancerCare-Spring Valley
Spring Valley, Illinois, United States, 61362
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Clinic-Urbana Main
Urbana, Illinois, United States, 61801
Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Saint Vincent Hospital and Health Services
Indianapolis, Indiana, United States, 46260
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Sidney and Lois Eskenazi Hospital
Indianapolis, Indiana, United States, 46202
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
IU Health La Porte Hospital
La Porte, Indiana, United States, 46350
IU Health Arnett
Lafayette, Indiana, United States, 47904
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States, 46360
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Reid Hospital and Health Care Services
Richmond, Indiana, United States, 47374
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46628
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
South Bend Clinic
South Bend, Indiana, United States, 46617
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Constantinou, Costas L MD (UIA Investigator)
Bettendorf, Iowa, United States, 52722
Genesis Medical Center - East Campus
Davenport, Iowa, United States, 52803
Genesis Medical Center - West Campus
Davenport, Iowa, United States, 52804
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Capitol
Des Moines, Iowa, United States, 50307
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
Covenant Medical Center
Waterloo, Iowa, United States, 50702
United States, Kansas
Hospital District Sixth of Harper County
Anthony, Kansas, United States, 67003
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States, 66606
Stormont-Vail Regional Health Center
Topeka, Kansas, United States, 66604
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita CCOP
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70806
Louisiana State University Health Science Center
New Orleans, Louisiana, United States, 70112
Interim LSU Public Hospital
New Orleans, Louisiana, United States, 70112
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
York Hospital
York, Maine, United States, 03909
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
Memorial Hospital at Easton - Shore Regional Cancer Center
Easton, Maryland, United States, 21601
The Memorial Hospital at Easton
Easton, Maryland, United States, 21601
United States, Michigan
Hickman Cancer Center
Adrian, Michigan, United States, 49221
Bixby Medical Center
Adrian, Michigan, United States, 49221
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49431
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Hurley Medical Center
Flint, Michigan, United States, 48502
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Allegiance Health
Jackson, Michigan, United States, 49201
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Mercy Memorial Hospital
Monroe, Michigan, United States, 48162
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Lakeland Hospital
St. Joseph, Michigan, United States, 49085
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Essentia Health Duluth Clinic CCOP
Duluth, Minnesota, United States, 55805
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Litchfield, Minnesota, United States, 55355
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Mayo Clinic
Rochester, Minnesota, United States, 55905
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Saint Joseph's Hospital - Healtheast
Saint Paul, Minnesota, United States, 55102
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
United States, Missouri
Southeast Missouri Hospital
Cape Girardeau, Missouri, United States, 63701
Capital Regional Medical Center
Jefferson City, Missouri, United States, 65101
Mercy Hospital-Joplin
Joplin, Missouri, United States, 64804
Center for Cancer Care and Research
Saint Louis, Missouri, United States, 63141
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States, 65804
United States, Montana
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Billings Clinic
Billings, Montana, United States, 59107-7000
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States, 59102
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Great Falls Clinic
Great Falls, Montana, United States, 59405
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, United States, 59405
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Northern Montana Hospital
Havre, Montana, United States, 59501
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Specialists
Missoula, Montana, United States, 59802
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Community Medical Hospital
Missoula, Montana, United States, 59801
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
United States, Nebraska
Good Samaritan Hospital
Kearney, Nebraska, United States, 68847
United States, New Hampshire
Portsmouth Regional Hospital
Portsmouth, New Hampshire, United States, 03802
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Overlook Hospital
Summit, New Jersey, United States, 07902
Inspira Medical Center Vineland
Vineland, New Jersey, United States, 08360
United States, New York
Montefiore Medical Center - Moses Campus
Bronx, New York, United States, 10467-2490
Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Orange Regional Medical Center
Middletown, New York, United States, 10940
Interlakes Foundation Inc-Rochester
Rochester, New York, United States, 14623
University of Rochester
Rochester, New York, United States, 14642
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Mission Hospital-Memorial Campus
Asheville, North Carolina, United States, 28801
Cape Fear Valley Health System
Fayetteville, North Carolina, United States, 28304
Gaston Memorial Hospital
Gastonia, North Carolina, United States, 28054
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
United States, North Dakota
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
Saint Alexius Medical Center
Bismarck, North Dakota, United States, 58501
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
United States, Ohio
Mary Rutan Hospital
Bellefontaine, Ohio, United States, 43311
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States, 43402
Mercy Medical Center
Canton, Ohio, United States, 44708
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
Case Western Reserve University
Cleveland, Ohio, United States, 44106
North Coast Cancer Care-Clyde
Clyde, Ohio, United States, 43410
Doctors Hospital
Columbus, Ohio, United States, 43228
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Grant Medical Center
Columbus, Ohio, United States, 43215
Columbus CCOP
Columbus, Ohio, United States, 43215
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Dayton CCOP
Dayton, Ohio, United States, 45420
Grandview Hospital
Dayton, Ohio, United States, 45405
Veteran Affairs Medical Center
Dayton, Ohio, United States, 45428
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Hematology Oncology Center Incorporated
Elyria, Ohio, United States, 44035
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Kettering Medical Center
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States, 43537
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States, 43537
Saint Luke's Hospital
Maumee, Ohio, United States, 43537
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States, 43616
Saint Charles Hospital
Oregon, Ohio, United States, 43616
North Coast Cancer Care
Sandusky, Ohio, United States, 44870
Springfield Regional Medical Center
Springfield, Ohio, United States, 45505
Flower Hospital
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Mercy Saint Anne Hospital
Toledo, Ohio, United States, 43623
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States, 43606
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States, 43623
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States, 43617
University of Toledo
Toledo, Ohio, United States, 43614
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Saint Ann's Hospital
Westerville, Ohio, United States, 43081
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Genesis HealthCare System
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Cancer Care Associates
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Providence Milwaukie Hospital
Milwaukie, Oregon, United States, 97222
Adventist Medical Center
Portland, Oregon, United States, 97216
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center
Portland, Oregon, United States, 97225
Western Oncology Research Consortium
Portland, Oregon, United States, 97213
United States, Pennsylvania
Doylestown Hospital
Doylestown, Pennsylvania, United States, 18901
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
Pottstown Memorial Medical Center
Pottstown, Pennsylvania, United States, 19464
Saint Joseph Medical Center
Reading, Pennsylvania, United States, 19605
Grand View Hospital
Sellersville, Pennsylvania, United States, 18960
United States, Rhode Island
Hematology and Oncology Associates of Rhode Island Inc
Cranston, Rhode Island, United States, 02920
Kent County Hospital
Warwick, Rhode Island, United States, 02886
United States, South Dakota
Conklin Regional Cancer Center
Aberdeen, South Dakota, United States, 57401
United States, Tennessee
Erlanger Medical Center
Chattanooga, Tennessee, United States, 37403
University of Tennessee - Memphis
Memphis, Tennessee, United States, 38163
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
Saint Paul Hospital
Dallas, Texas, United States, 75390
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Zale Lipshy University Hospital
Dallas, Texas, United States, 75235
Scott and White Memorial Hospital
Temple, Texas, United States, 76508
United States, Virginia
Danville Regional Medical Center
Danville, Virginia, United States, 24541
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States, 22401
United States, Washington
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States, 98310
Columbia Basin Hematology and Oncology PLLC
Kennewick, Washington, United States, 99336
Group Health Cooperative-Seattle
Seattle, Washington, United States, 98112
Harborview Medical Center
Seattle, Washington, United States, 98104
University of Washington Medical Center
Seattle, Washington, United States, 98195
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
The Polyclinic
Seattle, Washington, United States, 98122
Minor and James Medical PLLC
Seattle, Washington, United States, 98104
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98664
United States, West Virginia
West Virginia University Charleston
Charleston, West Virginia, United States, 25304
West Virginia University Healthcare
Morgantown, West Virginia, United States, 26506
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States, 26101
United States, Wisconsin
Langlade Hospital and Cancer Center
Antigo, Wisconsin, United States, 54409
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire, Wisconsin, United States, 54701
Sacred Heart Hospital
Eau Claire, Wisconsin, United States, 54701
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
UW Cancer Center Johnson Creek
Johnson Creek, Wisconsin, United States, 53038
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Dean Hematology and Oncology Clinic
Madison, Wisconsin, United States, 53717
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Saint Joseph's Hospital
Marshfield, Wisconsin, United States, 54449
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Marshfield Clinic at James Beck Cancer Center
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic-Rice Lake Center
Rice Lake, Wisconsin, United States, 54868
Saint Michael's Hospital
Stevens Point, Wisconsin, United States, 54481
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Diagnostic and Treatment Center
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States, 54494
Riverview Hospital
Wisconsin Rapids, Wisconsin, United States, 54494
United States, Wyoming
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Investigators
Principal Investigator: Ingrid Mayer ECOG-ACRIN Cancer Research Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00520975     History of Changes
Other Study ID Numbers: NCI-2009-00504, NCI-2009-00504, CDR0000561762, E1105, E1105, U10CA180820, U10CA021115
Study First Received: August 24, 2007
Last Updated: July 11, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Antibodies
Antibodies, Monoclonal
Trastuzumab
Bevacizumab
Carboplatin
Paclitaxel
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014