Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed By Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00861705
First received: March 12, 2009
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

This randomized phase II trial is studying how well giving paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide, 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 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. Giving chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.


Condition Intervention Phase
Estrogen Receptor-negative Breast Cancer
HER2-negative Breast Cancer
Male Breast Cancer
Progesterone Receptor-negative Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Triple-negative Breast Cancer
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Drug: cyclophosphamide
Biological: bevacizumab
Drug: carboplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pathologic complete response (pCR), defined as the absence of residual invasive carcinoma in the breast [ Time Frame: At the time of definitive surgical removal ] [ Designated as safety issue: No ]
    Will use two separate chi-square tests, one for each factor, to assess the difference in proportion of pCR in the breast between the control and experimental groups. Will use exact binomial methods to construct 95% confidence intervals around the pCR incidence by factor.


Secondary Outcome Measures:
  • Pathologic stage in the breast and in the breast plus axilla as measured by AJCC TNM criteria (version 6) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Clinical response assessed by tumor measurement [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Time-to-event distributions will be shown graphically using the Kaplan-Meier product-limit technique. The difference between two or more distributions will be assessed using the logrank test.

  • Radiographic response assessed by tumor measurement [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Time-to-event distributions will be shown graphically using the Kaplan-Meier product-limit technique. The difference between two or more distributions will be assessed using the logrank test.

  • Overall survival [ Time Frame: From study entry to death due to any cause, up to 10 years ] [ Designated as safety issue: No ]
    Time-to-event distributions will be shown graphically using the Kaplan-Meier product-limit technique. The difference between two or more distributions will be assessed using the logrank test.

  • Recurrence-free survival [ Time Frame: From definitive surgery to first instance of ipsilateral invasive breast tumor recurrence, local/regional invasive breast cancer recurrence, distant recurrence, or death from any cause, up to 10 years ] [ Designated as safety issue: No ]
    Time-to-event distributions will be shown graphically using the Kaplan-Meier product-limit technique. The difference between two or more distributions will be assessed using the logrank test.

  • Time to first failure, defined as first instance of ipsilateral invasive breast tumor recurrence, local/regional invasive breast cancer recurrence, distant recurrence, or death from any cause [ Time Frame: From study entry to first event, up to 10 years ] [ Designated as safety issue: No ]
    Time-to-event distributions will be shown graphically using the Kaplan-Meier product-limit technique. The difference between two or more distributions will be assessed using the logrank test.

  • Incidence and severity of post-op complications, especially excessive bleeding, delayed wound healing, and thrombotic complications assessed by NCI Common Terminology Criteria for Adverse Events version 3 [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
  • Frequency and severity of toxicity incidents assessed by Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 445
Study Start Date: May 2009
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (doxorubicin, paclitaxel, cyclophosphamide)
Patients receive paclitaxel IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Experimental: Arm II (doxorubicin, combination chemotherapy, bevacizumab)
Patients receive paclitaxel and ddAC as in arm I. Patients also receive bevacizumab IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF
Experimental: Arm III (doxorubicin, combination chemotherapy, carboplatin)
Patients receive paclitaxel and ddAC as in arm I. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Experimental: Arm IV (doxorubicin, chemotherapy, carboplatin, bevacizumab)
Patients receive paclitaxel and ddAC as in arm I, bevacizumab as in arm II, and carboplatin as in arm III.
Drug: doxorubicin hydrochloride
Given IV
Other Names:
  • ADM
  • ADR
  • Adria
  • Adriamycin PFS
  • Adriamycin RDF
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: cyclophosphamide
Given IV
Other Names:
  • CPM
  • CTX
  • Cytoxan
  • Endoxan
  • Endoxana
Biological: bevacizumab
Given IV
Other Names:
  • anti-VEGF humanized monoclonal antibody
  • anti-VEGF monoclonal antibody
  • Avastin
  • rhuMAb VEGF
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin

  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 invasive breast cancer by core needle or incisional biopsy (excisional biopsy is not allowed)

    • Clinical stage II-III disease

      • No inflammatory breast cancer
    • Resectable disease

      • Intent to undergo surgery after completion of neoadjuvant therapy
  • Hormone receptor status poor, defined as estrogen receptor-negative and progesterone receptor-negative tumor OR staining present in ≤ 10% of invasive cancer cells by IHC
  • HER2-negative disease, defined as IHC0-1+ OR FISH ratio (HER2 gene copy/chromosome 17) of < 2.0
  • Measurable disease, defined as clinically orradiographically measurable target lesion in the breast that is ≥ 1 cm

    • No axillary disease only (i.e., no identifiable tumor in the breast that is ≥ 1 cm onphysical exam or radiographic study)
  • Multicentric or bilateral disease allowed provided the target lesion meets the above eligibility criteria
  • Concurrent registration on CALGB-150709 required
  • Menopausal status not specified
  • Zubrod performance status 0-1
  • Granulocytes ≥ 1,000/μL
  • Platelets ≥ 100,000/μL
  • Total bilirubin ≤ 1.5 times upper limit of normal(ULN)
  • ALT ≤ 2.5 times ULN
  • Creatinine clearance> 30 mL/min
  • Urine protein ≤ 1+ by urinalysis OR urine protein:creatinine ratio < 1 OR 24-hour urine protein < 1 g
  • PT/INR ≤ 1.5 times ULN (INR ≤ 3 times ULN if patient is on stable, therapeutic doses of warfarin and has no active bleeding or pathologic condition that is associated with a high risk of bleeding)
  • LVEF > lower limit of normal by MUGA scan or echocardiogram
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective, non-hormonal contraception during the entire period of study treatment
  • No significant history of bleeding (e.g., hemoptysis, upper or lower gastrointestinal bleeding) within the past 6 months
  • No serious or non-healing wound, skin ulcer, or bone fracture
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • No baseline neuropathy ≥ grade 2
  • No congestive heart failure
  • No myocardial infarction, unstable angina pectoris, arterial thrombotic event, stroke, or transient ischemia attack within the past 12 months
  • No uncontrolled hypertension (systolic blood pressure [BP] > 160 mm Hg or diastolic BP > 90 mm Hg), uncontrolled or symptomatic arrhythmia, or peripheral vascular disease ≥ grade 2
  • More than 28 days since prior and no concurrent major surgical procedure; the following are NOT considered to be major surgical procedures:

    • Obtaining the required research needle biopsies
    • Placement of a radiopaque clip to localize a tumor or tumors for subsequent surgical resection
    • Placement of a port for central venous access
    • Fine needle aspiration of a prominent or suspicious axillary lymph node
    • Needle biopsy of a clinically or radiographically detected lesion to rule out metastatic disease
    • Pretreatment sentinel lymph node sampling
  • No prior chemotherapy, hormonal therapy, or radiotherapy with therapeutic intent for this cancer
  • No other concurrent chemotherapy
  • No concurrent hormonal therapy, except steroids for adrenal failure or hormones for non-disease-related conditions (e.g., insulin for diabetes, dexamethasone as pre-treatment for paclitaxel, or dexamethasone as an antiemetic)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00861705

  Hide Study Locations
Locations
United States, Arkansas
NEA Baptist Clinic-Matthews
Jonesboro, Arkansas, United States, 72401
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, United States, 72401
Highlands Oncology Group-Rogers
Rogers, Arkansas, United States, 72758
United States, California
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States, 94704
Roy and Patricia Disney Family Cancer Center
Burbank, California, United States, 91505
Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
Mills - Peninsula Hospitals
Burlingame, California, United States, 94010
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
City of Hope Medical Center
Duarte, California, United States, 91010
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States, 94538
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States, 94904
Breastlink Medical Group Inc
Long Beach, California, United States, 90806
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States, 94040
El Camino Hospital
Mountain View, California, United States, 94040
Bay Area Breast Surgeons Inc
Oakland, California, United States, 94609
Larry G Strieff MD Medical Corporation
Oakland, California, United States, 94609
Bay Area Tumor Institute
Oakland, California, United States, 94609
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
Epic Care-Oakland
Oakland, California, United States, 94612
Highland General Hospital
Oakland, California, United States, 94602
Tom K Lee Inc
Oakland, California, United States, 94609
Saint Joseph Hospital
Orange, California, United States, 92868
Desert Regional Medical Center
Palm Springs, California, United States, 92262
Palo Alto Medical Foundation Heath Care
Palo Alto, California, United States, 94301
Valley Medical Oncology Consultants
Pleasanton, California, United States, 94588
Valley Care Health System - Pleasanton
Pleasanton, California, United States, 94588
Salinas Valley Memorial
Salinas, California, United States, 93901
California Pacific Medical Center
San Francisco, California, United States, 94118
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, United States, 94806
Sutter Pacific Medical Foundation
Santa Rosa, California, United States, 95403
Sutter Solano Medical Center
Vallejo, California, United States, 94589
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
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Saint Anthony Central Hospital
Denver, Colorado, United States, 80204
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Rose Medical Center
Denver, Colorado, United States, 80220
Swedish Medical Center
Englewood, Colorado, United States, 80110
Poudre Valley Hospital
Fort Collins, Colorado, United States, 80524
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80528
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Littleton Adventist Hospital
Littleton, Colorado, United States, 80122
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
Parker Adventist Hospital
Parker, Colorado, United States, 80138
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
Saint Vincent's Medical Center
Bridgeport, Connecticut, United States, 06606
Greenwich Hospital
Greenwich, Connecticut, United States, 06830
Hartford Hospital
Hartford, Connecticut, United States, 06102
Manchester Memorial Hospital
Manchester, Connecticut, United States, 06040
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University
Washington, District of Columbia, United States, 20057
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Florida
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Jupiter Medical Center
Jupiter, Florida, United States, 33458
Cancer Center of South Florida Foundation Inc-Lake Worth
Lake Worth, Florida, United States, 33461
Mount Sinai Medical Center CCOP
Miami Beach, Florida, United States, 33140
Florida Hospital
Orlando, Florida, United States, 32803
United States, Georgia
Phoebe Putney Memorial Hospital
Albany, Georgia, United States, 31701
Northside Hospital
Atlanta, Georgia, United States, 30342
Atlanta Regional CCOP
Atlanta, Georgia, United States, 30342
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Well Star Cobb Hospital
Austell, Georgia, United States, 30106
John B Amos Cancer Center
Columbus, Georgia, United States, 31904
Dekalb Medical Center
Decatur, Georgia, United States, 30033
Piedmont Fayette Hospital
Fayetteville, Georgia, United States, 30214
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30045
Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274
Harbin Clinic Medical Oncology and Clinical Research
Rome, Georgia, United States, 30165
Saint Joseph's-Candler Health System
Savannah, Georgia, United States, 31405
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
United States, Hawaii
Kapiolani Medical Center at Pali Momi
Aiea, Hawaii, United States, 96701
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Hawaii Medical Center East
Honolulu, Hawaii, United States, 96817
OnCare Hawaii-Liliha
Honolulu, Hawaii, United States, 96817-3169
Oncare Hawaii Inc-Kuakini
Honolulu, Hawaii, United States, 96817
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
University of Hawaii
Honolulu, Hawaii, United States, 96813
Oncare Hawaii Inc-POB II
Honolulu, Hawaii, United States, 96813
Castle Medical Center
Kailua, Hawaii, United States, 96734
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
Pacific Cancer Institute of Maui
Wailuku, Hawaii, United States, 96793
Maui Memorial Medical Center
Wailuku, Hawaii, United States, 96793
United States, Illinois
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637-1470
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States, 60612-3785
Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
University of Illinois
Chicago, Illinois, United States, 60612
Resurrection Healthcare
Chicago, Illinois, United States, 60631
Mount Sinai Hospital Medical Center
Chicago, Illinois, United States, 60608
Adventist La Grange Memorial Hospital
La Grange, Illinois, United States, 60525
Hematology Oncology Consultants Limited
Naperville, Illinois, United States, 60540
West Suburban Cancer Center
River Forest, Illinois, United States, 60305
Swedish American Hospital
Rockford, Illinois, United States, 61104
United States, Indiana
Saint Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
Elkhart Clinic
Elkhart, Indiana, United States, 46514-2098
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States, 46514
Fort Wayne Medical Oncology and Hematology Inc - State Boulevard
Fort Wayne, Indiana, United States, 46845
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
Indiana University Health La Porte Hospital
La Porte, Indiana, United States, 46350
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545-1470
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States, 46563
Reid Hospital and Health Care Services
Richmond, Indiana, United States, 47374
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
South Bend Clinic
South Bend, Indiana, United States, 46617
Michiana Hematology Oncology-PC Westville
Westville, Indiana, United States, 46391
United States, Iowa
Helen G Nassif Community Cancer Center
Cedar Rapids, Iowa, United States, 52402
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Saint Luke's Hospital
Cedar Rapids, Iowa, United States, 52402
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
United States, Kansas
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
Hays Medical Center
Hays, Kansas, United States, 67601
Promise Regional Medical Center-Hutchinson
Hutchinson, Kansas, United States, 65702
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Saint Luke's South Hospital
Overland Park, Kansas, United States, 66213
Menorah Medical Center
Overland Park, Kansas, United States, 66209
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, United States, 66762
Kansas City CCOP
Prairie Village, Kansas, United States, 66208
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Salina Regional Health Center
Salina, Kansas, United States, 67401
Shawnee Mission Medical Center
Shawnee Mission, Kansas, United States, 66204
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States, 66606
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas - Main Office
Wichita, Kansas, United States, 67214
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States, 67208
Wichita CCOP
Wichita, Kansas, United States, 67214
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Associates In Womens Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
Maine Center for Cancer Medicine and Blood Disorders-Scarborough
Scarborough, Maine, United States, 04074
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201-1595
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
Frederick Memorial Hospital
Frederick, Maryland, United States, 21701
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
Addison Gilbert Hospital
Gloucester, Massachusetts, United States, 01930
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford, Massachusetts, United States, 01757
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
United States, Michigan
Bixby Medical Center
Adrian, Michigan, United States, 49221
Hickman Cancer Center
Adrian, Michigan, United States, 49221
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49431
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Mid-Michigan Medical Center - Midland
Midland, Michigan, United States, 48670
Mercy Memorial Hospital
Monroe, Michigan, United States, 48162
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Michiana Hematology Oncology PC-Niles
Niles, Michigan, United States, 49120
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Lakeland Hospital
St. Joseph, Michigan, United States, 49085
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
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
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital
Saint Paul, Minnesota, United States, 55101
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Central Care Cancer Center-Carrie J Babb Cancer Center
Bolivar, Missouri, United States, 65613
CoxHealth Cancer Center
Branson, Missouri, United States, 65616
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
University of Missouri - Ellis Fischel
Columbia, Missouri, United States, 65203
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States, 65109
Heartland Hematology and Oncology Associates Incorporated
Kansas City, Missouri, United States, 64118
Truman Medical Center
Kansas City, Missouri, United States, 64108
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States, 64111
Saint Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
North Kansas City Hospital
Kansas City, Missouri, United States, 64116
Research Medical Center
Kansas City, Missouri, United States, 64132
Saint Joseph Health Center
Kansas City, Missouri, United States, 64114
Saint Luke's East - Lee's Summit
Lee's Summit, Missouri, United States, 64086
Liberty Hospital
Liberty, Missouri, United States, 64068
Liberty Radiation Oncology Clinic
Liberty, Missouri, United States, 64068
Phelps County Regional Medical Center
Rolla, Missouri, United States, 65401
Saint John's Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States, 65401
Heartland Regional Medical Center
Saint Joseph, Missouri, United States, 64506
Saint Joseph Oncology Inc
Saint Joseph, Missouri, United States, 64507
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
Saint Louis University Hospital
Saint Louis, Missouri, United States, 63110
Comprehensive Cancer Care PC
Saint Louis, Missouri, United States, 63141
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States, 65802
Saint John's Hospital
Springfield, Missouri, United States, 65804
Cox Medical Center
Springfield, Missouri, United States, 65807
United States, Montana
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States, 59102
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Billings Clinic
Billings, Montana, United States, 59107-7000
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
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
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Big Sky Oncology
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Northern Montana Hospital
Havre, Montana, United States, 59501
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Glacier Oncology PLLC
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
United States, New Hampshire
New Hampshire Oncology-Hematology PA
Concord, New Hampshire, United States, 03301
Exeter Hospital
Exeter, New Hampshire, United States, 03833
New Hampshire Oncology Hematology Associates
Hooksett, New Hampshire, United States, 03106
LRGHealthcare-Lakes Region General Hospital
Laconia, New Hampshire, United States, 03246
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Norris Cotton Cancer Center-Manchester
Manchester, New Hampshire, United States, 03102
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County
Mount Holly, New Jersey, United States, 08060
UMDNJ - New Jersey Medical School
Newark, New Jersey, United States, 07103
Virtua West Jersey Hospital Voorhees
Voorhees, New Jersey, United States, 08043
United States, New York
Coney Island Hospital
Brooklyn, New York, United States, 11235
Maimonides Medical Center
Brooklyn, New York, United States, 11219
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Hematology Oncology Associates of Central New York PC
East Syracuse, New York, United States, 13057
Elmhurst Hospital Center
Elmhurst, New York, United States, 11373
Glens Falls Hospital
Glens Falls, New York, United States, 12801
Queens Hospital Center
Jamaica, New York, United States, 11432
Orange Regional Medical Center
Middletown, New York, United States, 10940
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Mount Sinai Medical Center
New York, New York, United States, 10029
Beth Israel Medical Center
New York, New York, United States, 10003
Saint Luke's Roosevelt Hospital Center - Saint Luke's Division
New York, New York, United States, 10025
Staten Island University Hospital
Staten Island, New York, United States, 10305
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Randolph Hospital
Asheboro, North Carolina, United States, 27203
Mission Hospitals
Asheville, North Carolina, United States, 28801
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Presbyterian Hospital
Charlotte, North Carolina, United States, 28204
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Cone Health Cancer Center
Greensboro, North Carolina, United States, 27403
Kinston Medical Specialists PA
Kinston, North Carolina, United States, 28501
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, United States, 28374
Rex Cancer Center
Raleigh, North Carolina, United States, 27607
Annie Penn Memorial Hospital
Reidsville, North Carolina, United States, 27320
Nash General Hospital
Rocky Mount, North Carolina, United States, 27804
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139
Iredell Memorial Hospital
Statesville, North Carolina, United States, 28677
Forsyth Memorial Hospital
Winston-Salem, North Carolina, United States, 27103
United States, North Dakota
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
United States, Ohio
Summa Akron City Hospital
Akron, Ohio, United States, 44304
Akron General Medical Center
Akron, Ohio, United States, 44307
Summa Barberton Hospital
Barberton, Ohio, United States, 44203
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States, 43402
Aultman Health Foundation
Canton, Ohio, United States, 44710
North Coast Cancer Care-Clyde
Clyde, Ohio, United States, 43410
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Dayton CCOP
Dayton, Ohio, United States, 45420
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Grandview Hospital
Dayton, Ohio, United States, 45405
Miami Valley Hospital
Dayton, Ohio, United States, 45409
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States, 45406
Hematology Oncology Center Incorporated
Elyria, Ohio, United States, 44035
Community Health Partners Regional Medical Center
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
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Saint Rita's Medical Center
Lima, Ohio, United States, 45801
Mansfield General Hospital-MedCentral Health System
Mansfield, Ohio, United States, 44903
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States, 43537
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States, 43537-1839
Saint Luke's Hospital
Maumee, Ohio, United States, 43537
Fisher-Titus Medical Center
Norwalk, Ohio, United States, 44857
Saint Charles Hospital
Oregon, Ohio, United States, 43616
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States, 43616
North Coast Cancer Care
Sandusky, Ohio, United States, 44870
Flower Hospital
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
University of Toledo
Toledo, Ohio, United States, 43614
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States, 43606
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States, 43623
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States, 43617
Mercy Cancer Center at Saint Anne Mercy Hospital
Toledo, Ohio, United States, 43623
Upper Valley Medical Center
Troy, Ohio, United States, 45373
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Bay Area Hospital
Coos Bay, Oregon, United States, 97420
United States, Pennsylvania
Saint Luke's Hospital
Bethlehem, Pennsylvania, United States, 18015
Butler Memorial Hospital
Butler, Pennsylvania, United States, 16001
Adams Cancer Center
Gettysburg, Pennsylvania, United States, 17325
Cherry Tree Cancer Center
Hanover, Pennsylvania, United States, 17331
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Aria Health-Torresdale Campus
Philadelphia, Pennsylvania, United States, 19114
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
Guthrie Clinic-Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
York Hospital
York, Pennsylvania, United States, 17405
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
Miriam Hospital
Providence, Rhode Island, United States, 02906
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Kent County Hospital
Warwick, Rhode Island, United States, 02886
United States, South Carolina
AnMed Health Cancer Center
Anderson, South Carolina, United States, 29621
AnMed Health Hospital
Anderson, South Carolina, United States, 29621
Roper Hospital
Charleston, South Carolina, United States, 29401
Cancer Centers of the Carolinas - Easley
Easley, South Carolina, United States, 29640
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Saint Francis Hospital
Greenville, South Carolina, United States, 29601
Cancer Centers of the Carolinas - Faris
Greenville, South Carolina, United States, 29605
Greenville CCOP
Greenville, South Carolina, United States, 29615
Cancer Centers of the Carolinas - Grove Commons
Greenville, South Carolina, United States, 29605
Self Regional Healthcare
Greenwood, South Carolina, United States, 29646
Cancer Centers of the Carolinas-Greer Medical Oncology
Greer, South Carolina, United States, 29650
Cancer Centers of the Carolinas - Seneca
Seneca, South Carolina, United States, 29672
Upstate Carolina CCOP
Spartanburg, South Carolina, United States, 29303
Cancer Centers of the Carolinas - Spartanburg
Spartanburg, South Carolina, United States, 29307
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center
Sioux Falls, South Dakota, United States, 57105
Sanford Cancer Center-Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
Erlanger Medical Center
Chattanooga, Tennessee, United States, 37403
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
Meharry Medical College
Nashville, Tennessee, United States, 37208-3599
Nashville Oncology Associates PC
Nashville, Tennessee, United States, 37203
United States, Texas
Doctor's Hospital of Laredo
Laredo, Texas, United States, 78041
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79430
United States, Utah
American Fork Hospital
American Fork, Utah, United States, 84003
Sandra L Maxwell Cancer Center
Cedar City, Utah, United States, 84720
Logan Regional Hospital
Logan, Utah, United States, 84321
Intermountain Medical Center
Murray, Utah, United States, 84157
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center
Provo, Utah, United States, 84604-3337
Dixie Medical Center Regional Cancer Center
Saint George, Utah, United States, 84770
LDS Hospital
Salt Lake City, Utah, United States, 84143
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, United States, 84106
United States, Virginia
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States, 22401
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia, United States, 22408
Virginia Oncology Associates-Hampton
Hampton, Virginia, United States, 23666
United States, Washington
Cancer Care Center at Island Hospital
Anacortes, Washington, United States, 98221
Auburn Regional Medical Center
Auburn, Washington, United States, 98002
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Harrison Bremerton Hematology and Oncology
Bremerton, Washington, United States, 98310
Highline Medical Center-Main Campus
Burien, Washington, United States, 98166
Providence Centralia Hospital
Centralia, Washington, United States, 98531
Saint Francis Hospital
Federal Way, Washington, United States, 98003
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States, 98029
Columbia Basin Hematology and Oncology PLLC
Kennewick, Washington, United States, 99336
Skagit Valley Hospital
Mount Vernon, Washington, United States, 98274
Providence - Saint Peter Hospital
Olympia, Washington, United States, 98506-5166
Harrison Poulsbo Hematology and Oncology
Poulsbo, Washington, United States, 98370
Good Samaritan Community Hospital
Puyallup, Washington, United States, 98372
Group Health Cooperative
Seattle, Washington, United States, 98112
University of Washington Medical Center
Seattle, Washington, United States, 98195
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
Harborview Medical Center
Seattle, Washington, United States, 98104
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
United General Hospital
Sedro-Woolley, Washington, United States, 98284
Evergreen Hematology and Oncology PS
Spokane, Washington, United States, 99218
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Northwest CCOP
Tacoma, Washington, United States, 98405
Allenmore Hospital
Tacoma, Washington, United States, 98405
Multicare Health System
Tacoma, Washington, United States, 98415
Saint Joseph Medical Center
Tacoma, Washington, United States, 98405
Saint Clare Hospital
Tacoma, Washington, United States, 98499
Providence Saint Mary Regional Cancer Center
Walla Walla, Washington, United States, 99362
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, West Virginia
Princeton Community Hospital
Princeton, West Virginia, United States, 24740
United States, Wisconsin
Fox Valley Surgical Associates Limited
Appleton, Wisconsin, United States, 54911
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311-6519
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Vince Lombardi Cancer Clinic-Marinette
Marinette, Wisconsin, United States, 54143
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Saint Nicholas Hospital
Sheboygan, Wisconsin, United States, 53081
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Aurora Medical Center in Summit
Summit, Wisconsin, United States, 53066
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States, 53226
Aurora West Allis Medical Center
West Allis, Wisconsin, United States, 53227
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Investigators
Principal Investigator: William Sikov Cancer and Leukemia Group B
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00861705     History of Changes
Other Study ID Numbers: NCI-2009-01172, NCI-2009-01172, CALGB-40603, CALGB 40603/CTSU 40603, CDR0000636850, CALGB 40603, CALGB-40603, U10CA031946
Study First Received: March 12, 2009
Last Updated: October 18, 2013
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
Cyclophosphamide
Bevacizumab
Doxorubicin
Carboplatin
Paclitaxel
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors

ClinicalTrials.gov processed this record on April 14, 2014