Bevacizumab and Combination Chemotherapy in Patients With Lymph Node Positive Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
North Central Cancer Treatment Group
Cancer and Leukemia Group B
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00119262
First received: July 12, 2005
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

This phase II trial is studying how well giving bevacizumab together with combination chemotherapy works in treating patients who have undergone surgery for breast cancer that has spread to the lymph nodes. Monoclonal antibodies, such as 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. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with more than one chemotherapy drug (combination chemotherapy), may be a better way to block tumor growth.


Condition Intervention Phase
Breast Cancer
Biological: bevacizumab
Biological: filgrastim
Biological: pegfilgrastim
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Feasibility Trial Incorporating Bevacizumab Into Dose Dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Patients With Lymph Node Positive Breast Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Congestive Heart Failure Rate [ Time Frame: assessed on day 1 of cycles 5, 9, 17 and 25, and at end of treatment, then every 3 months for <2 years and every 6 months for 2-3 years from study entry ] [ Designated as safety issue: Yes ]
    Clinical congestive heart failure includes patients with symptomatic decline in LVEF to at or below the lower limit of normal (LLN), or symptomatic diastolic dysfunction. 223 treated patients were included in the analysis.


Secondary Outcome Measures:
  • Proportion of Patients With Absolute Decrease in Left Ventricular Ejection Fraction (LVEF) Levels Post Doxorubicin and Cyclophosphamide(AC) [ Time Frame: assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatment ] [ Designated as safety issue: Yes ]
    The endpoint was measured by absolute decrease from baseline in LVEF of >15% or >10% decline from baseline to below the LLN post doxorubicin and cyclophosphamide (AC) Day 1 Cycle 5 (DIC5). 207 patients who were treated and had baseline and DIC5 LVEF values were included in the analysis.

  • Proportion of Patients With Absolute Decrease in LVEF Levels Post Bevacizumab [ Time Frame: assessed on day 1 of cycles 5, 9, 17, 25, and at end of treatment ] [ Designated as safety issue: Yes ]
    The endpoint was measured by absolute decrease from baseline in LVEF of >15% or >10% decline from baseline to below the LLN post bevacizumab (the end of treatment). 158 patients who were treated and had baseline and end of treatment LVEF values were included in the analysis.


Enrollment: 226
Study Start Date: October 2005
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm A (ddBAC > BT > B) Biological: bevacizumab
10 mg/kg intravenous (IV) infusion after doxorubicin and cyclophosphamide (AC) on day 1 of each cycle (14 days) for 26 cycles for both Arms. Bevacizumab binds Vascular Endothelial Growth Factor (VEGF) preventing the binding of VEGF to its receptors (flt-1 and kdr), thus inhibiting endothelial cell proliferation and new blood vessel formation.
Other Names:
  • NSC 704865
  • RhuMAb VEGF
  • Recombinant Humanized Monoclonal Anti-VEGF Antibody
Biological: filgrastim
Filgrastim (5μg/kg subcutaneously (SQ) ) days 2-11 or Pegfilgrastim (6 mg SQ) day 2 of each cycle (14 days). Filgrastim or Pegfilgrastim are not required during bevacizumab monotherapy.Filgrastim is a human granulocyte colony-stimulating factor (G-CSF).
Other Name: Neopogen
Biological: pegfilgrastim
Filgrastim (5μg/kg SQ) days 2-11 or Pegfilgrastim (6 mg SQ) day 2 of each cycle (14 days). Filgrastim or Pegfilgrastim are not required during bevacizumab monotherapy.Filgrastim is a human granulocyte colony-stimulating factor (G-CSF).
Other Names:
  • Neulasta
  • G-CSF
  • granlocyte - colony stimulating factor
Drug: cyclophosphamide
600 mg/m2, IV infusion in 250 ml saline solution (NS) over 20-30 minutes on day 1 of each cycle (14 days) for 4 cycles.
Other Names:
  • Cytoxan
  • Neosar
  • CTX
  • CPM
Drug: doxorubicin hydrochloride
60 mg/m2, IV push through running IV of NS, day 1 of each cycle (14 days) for 4 cycles
Other Names:
  • Adriamycin
  • Rubex
  • Adriamycin RDF
  • Adriamycin PFS
  • hydroxydaunorubicin
  • hydroxydaunomycin
  • ADR
Drug: paclitaxel
175 mg/m2 IV infusion in 250 ml NS or D5W over 3 hours on day 1 of each cycle for 4 cycles
Other Names:
  • Taxol
  • NSC 673089
Active Comparator: Arm B (ddAC > BT > B) Biological: bevacizumab
10 mg/kg intravenous (IV) infusion after doxorubicin and cyclophosphamide (AC) on day 1 of each cycle (14 days) for 26 cycles for both Arms. Bevacizumab binds Vascular Endothelial Growth Factor (VEGF) preventing the binding of VEGF to its receptors (flt-1 and kdr), thus inhibiting endothelial cell proliferation and new blood vessel formation.
Other Names:
  • NSC 704865
  • RhuMAb VEGF
  • Recombinant Humanized Monoclonal Anti-VEGF Antibody
Biological: filgrastim
Filgrastim (5μg/kg subcutaneously (SQ) ) days 2-11 or Pegfilgrastim (6 mg SQ) day 2 of each cycle (14 days). Filgrastim or Pegfilgrastim are not required during bevacizumab monotherapy.Filgrastim is a human granulocyte colony-stimulating factor (G-CSF).
Other Name: Neopogen
Biological: pegfilgrastim
Filgrastim (5μg/kg SQ) days 2-11 or Pegfilgrastim (6 mg SQ) day 2 of each cycle (14 days). Filgrastim or Pegfilgrastim are not required during bevacizumab monotherapy.Filgrastim is a human granulocyte colony-stimulating factor (G-CSF).
Other Names:
  • Neulasta
  • G-CSF
  • granlocyte - colony stimulating factor
Drug: cyclophosphamide
600 mg/m2, IV infusion in 250 ml saline solution (NS) over 20-30 minutes on day 1 of each cycle (14 days) for 4 cycles.
Other Names:
  • Cytoxan
  • Neosar
  • CTX
  • CPM
Drug: doxorubicin hydrochloride
60 mg/m2, IV push through running IV of NS, day 1 of each cycle (14 days) for 4 cycles
Other Names:
  • Adriamycin
  • Rubex
  • Adriamycin RDF
  • Adriamycin PFS
  • hydroxydaunorubicin
  • hydroxydaunomycin
  • ADR
Drug: paclitaxel
175 mg/m2 IV infusion in 250 ml NS or D5W over 3 hours on day 1 of each cycle for 4 cycles
Other Names:
  • Taxol
  • NSC 673089

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the incidence of clinically apparent cardiac dysfunction in patients with resected lymph node-positive breast cancer treated with adjuvant bevacizumab and dose dense doxorubicin and cyclophosphamide followed by paclitaxel.

SECONDARY OBJECTIVES:

I. Determine the changes in left ventricular ejection fraction (LVEF) in patients treated with this regimen.

II. Determine the non-cardiac toxicity of this regimen in these patients.

OUTLINE: This is a non-randomized, multicenter study. Patients are sequentially assigned to 1 of 2 treatment arms.

ARM A: Patients receive doxorubicin IV, cyclophosphamide IV over 20-30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive filgrastim (G-CSF) subcutaneously (SQ) on days 2-11 or pegfilgrastim SC on day 2. Treatment repeats every 14 days for 4 courses. Patients then receive paclitaxel IV over 3 hours and bevacizumab IV over 30-90 minutes on day 1. Patients also receive G-CSF or pegfilgrastim as above. Treatment with paclitaxel, bevacizumab, and G-CSF or pegfilgrastim repeats every 14 days for 4 courses. Patients then receive bevacizumab alone every 14 days for up to 18 courses.

ARM B: Patients receive doxorubicin, cyclophosphamide, and G-CSF or pegfilgrastim as in group I. Patients then receive paclitaxel, bevacizumab, and G-CSF or pegfilgrastim as in group I. Patients then receive bevacizumab alone every 14 days for up to 22 courses.

Treatment in both groups continues in the absence of disease recurrence or unacceptable toxicity.

Patients who require radiotherapy (post-lumpectomy) or who plan radiotherapy at the discretion of the investigator (post-mastectomy) undergo radiotherapy beginning within 6 weeks after the completion of chemotherapy.

Premenopausal patients with estrogen receptor (ER) and / or progesterone receptor (PR) positive disease receive oral tamoxifen once daily for 5 years beginning at the time of radiotherapy or within 6 weeks after the completion of chemotherapy. Postmenopausal patients with ER and / or PR positive disease receive an aromatase inhibitor (e.g., anastrozole, letrozole, or exemestane) or tamoxifen followed by an aromatase inhibitor once daily for up to 10 years.

After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for up to 3 years from study entry.

  Eligibility

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

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the breast
  • Node-positive disease in 1 or more axillary or internal mammary lymph node by histology with hematoxylin and eosin staining
  • Has undergone prior definitive breast surgery including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and sentinel node biopsy, lumpectomy and axillary dissection or lumpectomy and sentinel node biopsy within the past 29-84 days (arm A only)

    • Surgical margins must be histologically free of invasive tumor and ductal carcinoma in situ, but lobular carcinoma in situ allowed
  • Synchronous bilateral breast cancer diagnosed within the past month allowed provided the higher TNM (Tumor,Node,Metastasis) stage tumor meets study eligibility criteria
  • Age>=18
  • ECOG performance status of 0-2
  • Adequate organ function as evidenced by following, obtained within 8 weeks prior to registration:

    • Absolute neutrophil count ≥ 1,000/mm^3
    • Platelet count ≥ 100,000/mm^3
    • Bilirubin ≤ 1.5 mg/dL
    • Aspartate aminotransferase (AST) ≤ 2 times upper limit normal (ULN)
    • Prothrombin time international normalized ratio (PT INR) ≤ 1.5 times normal
    • Partial thromboplastin time (PTT) ≤ 1.5 times normal
    • Creatinine ≤ 1.5 mg/dL
    • Urine protein:creatinine ratio < 1.0
    • Left ventricular ejection fraction (LVEF) normal by multi gated acquisition scan (MUGA) or echocardiogram (ECHO)
  • Fertile patients must use effective contraception during and for 3-4 months after completion of study treatment
  • Prior tamoxifen or raloxifene for chemoprevention allowed
  • More than 4 weeks since prior major surgery

    • Non-operative biopsy or placement of a vascular access device is not considered major surgery
  • Regular use of cyclo-oxygenase-2 inhibitors or low-dose aspirin allowed

Exclusion Criteria:

  • With immunohistologic staining as the only evidence of nodal involvement
  • Her2/neu-positive disease(i.e.,3+ by immunohistochemistry or positive by fluorescent in situ hybridization)
  • Clinical evidence of inflammatory disease or fixed axillary nodes (N2)
  • History of myocardial infarction within the past year
  • History of unstable angina within the past year
  • History of arterial thrombotic events within the past year
  • Uncontrolled or clinically significant arrhythmia
  • New York Heart Association grade II-IV congestive heart failure
  • Peripheral vascular disease ≥ grade II
  • Uncontrolled hypertension, defined as systolic blood pressure (BP)>160 mm Hg or diastolic BP>90 mm Hg
  • History of deep venous thrombosis
  • History of cerebrovascular disease, including transient ischemic attack or stroke
  • Other clinically significant cardiovascular disease
  • History of pulmonary embolism
  • Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • Non-healing wound or bone fracture
  • Hypersensitivity to paclitaxel or drugs using Cremophor
  • Hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies
  • Pregnant
  • Nursing during and for ≥ 3-4 months after completion of study treatment
  • Prior cytotoxic chemotherapy for breast cancer
  • Prior anthracycline, anthracenedione, or taxane for any condition
  • Prior hormonal therapy for breast cancer
  • Other concurrent tamoxifen or raloxifene
  • Prior radiotherapy for breast cancer
  • Concurrent radiotherapy to the internal mammary chain
  • Concurrent therapeutic anticoagulants

    • Concurrent prophylactic use of anticoagulants to maintain patency of vascular assess device allowed
  • Concurrent regular use of aspirin (i.e., daily for ≥ 10 days at doses of > 325 mg/day) or regular therapeutic doses of other nonsteroidal anti-inflammatory drugs known to inhibit platelet function
  • Other concurrent drugs known to inhibit platelet function, including any of the following:

    • Dipyridamole
    • Ticlopidine
    • Clopidogrel
    • Cilostazol
  • Concurrent cardioprotectant agents
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00119262

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
United States, California
Memorial Medical Center Cancer Services
Modesto, California, United States, 95355
Community Hospital of the Monterey Peninsula Comprehensive Cancer Center
Monterey, California, United States, 93940
Stanford Comprehensive Cancer Center at Stanford University Medical Center
Stanford, California, United States, 94305
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224-2522
St. Joseph Hospital
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
Swedish Medical Center
Englewood, Colorado, United States, 80110
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80524
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80502
St. Mary-Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
United States, Connecticut
Bendheim Cancer Center at Greenwich Hospital
Greenwich, Connecticut, United States, 06830
Manchester Memorial Hospital
Manchester, Connecticut, United States, 06040
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
Carl and Dorothy Bennett Cancer Center at Stamford Hospital
Stamford, Connecticut, United States, 06904
United States, District of Columbia
George Washington University Medical Center
Washington, District of Columbia, United States, 20037
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Florida Hospital Cancer Institute at Florida Hospital Orlando
Orlando, Florida, United States, 32803-1273
United States, Illinois
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
Sherman Hospital
Elgin, Illinois, United States, 60120
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Ingalls Cancer Care Center at Ingalls Memorial Hospital
Harvey, Illinois, United States, 60426
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Moline, Illinois, United States, 61265
Trinity Medical Center - East
Moline, Illinois, United States, 61265
Swedish-American Regional Cancer Center
Rockford, Illinois, United States, 61104-2315
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Oncology/Hematology Associates of Southwest Indiana at St. Mary's Cancer Center
Evansville, Indiana, United States, 47714
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States, 46815
William N. Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Howard Community Hospital at Howard Regional Health System
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Arnett Cancer Care
Lafayette, Indiana, United States, 47904
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Hematology Oncology Associates of the Quad Cities
Bettendorf, Iowa, United States, 52722
Bettendorf, Iowa, United States, 52722
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316-2301
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, United States, 50266
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67203
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Maine
York Hospital
York, Maine, United States, 03909
United States, Maryland
DeCesaris Cancer Institute at Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Morton Hospital & Medical Center
Taunton, Massachusetts, United States, 02780
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Hurley Medical Center
Flint, Michigan, United States, 48503
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Foote Hospital
Jackson, Michigan, United States, 49201
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Borgess Medical Center
Kalamazooaa, Michigan, United States, 49001
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States, 48144
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48909
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Mercy Memorial Hospital System
Monroe, Michigan, United States, 48162
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States, 48601
Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
St. Joseph, Michigan, United States, 49085
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
MeritCare Clinic - Bemidji
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Cancer Care Center at St. Luke's Hospital
Duluth, Minnesota, United States, 55805
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Lichfield, Minnesota, United States, 55355
Minnesota Oncology Hematology, PA at Maplewood Cancer Center
Maplewood, Minnesota, United States, 55109
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Saint Francis Cancer Center
Shakopee, Minnesota, United States, 55379
St. Joseph's Hospital
St Paul, Minnesota, United States, 55102
Park Nicollet Health Services
St. Louis Park, Minnesota, United States, 55416
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
United Hospital
St. Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology Hematology, PA - Woodbury
Woodbury, Minnesota, United States, 55125
Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital
St Louis, Missouri, United States, 63110
United States, Nebraska
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Methodist Cancer Center at Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
United States, New Hampshire
New Hampshire Oncology-Hematology, PA - Hooksett
Hooksett, New Hampshire, United States, 03106
Elliot Regional Cancer Center at Elliot Hospital
Manchester, New Hampshire, United States, 03103
United States, New Jersey
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, United States, 08822
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
St. Barnabas Medical Center Cancer Center
Livingston, New Jersey, United States, 07039
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
Mountainside Hospital Cancer Center
Montclair, New Jersey, United States, 07042
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Booker Cancer Center at Riverview Medical Center
Red Bank, New Jersey, United States, 07701
Overlook Hospital
Summit, New Jersey, United States, 07902
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
NYU Cancer Institute at New York University Medical Center
New York, New York, United States, 10016
CCOP - Hematology-Oncology Associates of Central New York
Syracuse, New York, United States, 13057
United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Lenoir Memorial Cancer Center
Kinston, North Carolina, United States, 28501
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
MeritCare Medical Group
Fargo, North Dakota, United States, 58122
United States, Ohio
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States, 44710-1799
Mercy Cancer Center at Mercy Medical Center
Canton, Ohio, United States, 44708
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Fremont Memorial Hospital
Fremont, Ohio, United States, 43420
Kenton Oncology, Incorporated
Kenton, Ohio, United States, 43326
St. Rita's Medical Center
Lima, Ohio, United States, 45801
Lima Memorial Hospital
Lima, Ohio, United States, 45804
St. Luke's Hospital
Maumee, Ohio, United States, 43537
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Toledo Hospital
Toledo, Ohio, United States, 43606
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
Fulton County Health Center
Wauseon, Ohio, United States, 43567
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, United States, 19010
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
St. Mary Regional Cancer Center
Langhorne, Pennsylvania, United States, 19047
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, United States, 19301-1792
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Joan Karnell Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19107
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Hematology and Oncology Associates
Scranton, Pennsylvania, United States, 18510
Mercy Hospital Cancer Center - Scranton
Scranton, Pennsylvania, United States, 18501
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
Geisinger Medical Group - Scenery Park
State College, Pennsylvania, United States, 16801
Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center
Wilkes-Barre, Pennsylvania, United States, 18711
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
CCOP - MainLine Health
Wynnewood, Pennsylvania, United States, 19096
United States, Tennessee
Cancer Center at Erlanger Health
Chattanooga, Tennessee, United States, 37403
Baptist Regional Cancer Center at Baptist Hospital of East Tennessee
Knoxville, Tennessee, United States, 37901
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Wisconsin
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Marshfield Clinic - Marshfield Center
Marshfield, Wisconsin, United States, 54449
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Ministry Medical Group at Saint Mary's Hospital
Rhinelander, Wisconsin, United States, 54501
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Sponsors and Collaborators
North Central Cancer Treatment Group
Cancer and Leukemia Group B
Investigators
Study Chair: Kathy Miller, MD Indiana University Melvin and Bren Simon Cancer Center
  More Information

Additional Information:
Publications:
Miller KD, O'Neill A, Perez EA, et al.: Phase II feasibility trial incorporating bevacizumab into dose dense doxorubicin and cyclophosphamide followed by paclitaxel in patients with lymph node positive breast cancer: a trial of the Eastern Cooperative Oncology Group (E2104). [Abstract] Breast Cancer Res Treat 106 (1): A-3063, S147, 2007.

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00119262     History of Changes
Other Study ID Numbers: NCI-2012-02977, U10CA021115, E2104, CDR0000434634
Study First Received: July 12, 2005
Results First Received: April 4, 2011
Last Updated: February 26, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
male breast cancer
lymph node positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Bevacizumab
Doxorubicin
Paclitaxel
Lenograstim
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Adjuvants, Immunologic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on April 15, 2014