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
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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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Cyclophosphamide
Doxorubicin
Doxorubicin hydrochloride
Paclitaxel
Filgrastim
Sargramostim
Lenograstim
Granulocyte colony-stimulating factor
Pegfilgrastim
Bevacizumab
U.S. FDA Resources
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:
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:
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:
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:
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:
|
| 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:
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:
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:
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:
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:
|
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
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| 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 May 22, 2013