Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III 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:
NCT00770809
First received: October 9, 2008
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

This randomized phase III trial is studying paclitaxel to see how well it works when given together with trastuzumab and/or lapatinib in treating patients with stage II or stage III breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, 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. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel together with trastuzumab and/or lapatinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. It is not yet known which regimen is more effective in treating patients with breast cancer.


Condition Intervention Phase
HER2-positive Breast Cancer
Male Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Drug: lapatinib ditosylate
Biological: trastuzumab
Drug: paclitaxel
Other: laboratory biomarker analysis
Phase 3

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 III TRIAL OF PACLITAXEL + TRASTUZUMAB + LAPATINIB VERSUS PACLITAXEL + TRASTUZUMAB AS NEOADJUVANT TREATMENT OF HER2-POSITIVE PRIMARY BREAST CANCER

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Pathologic complete response (pCR) [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pathologic stage in the breast and axilla as defined by AJCC TNM v6.0 criteria [ Time Frame: At time of surgery ] [ Designated as safety issue: No ]
  • Clinical response at the completion of neoadjuvant therapy [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Radiographic response at the completion of neoadjuvant therapy [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Measured from study entry to death due to any cause, assessed up to 10 years ] [ Designated as safety issue: No ]
  • Relapse-free survival (RFS) [ Time Frame: From definitive surgery to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, or death from any cause, whichever occurs first, assessed up to 10 years ] [ Designated as safety issue: No ]
  • Time to first failure [ Time Frame: From study entry to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence or death from any cause, assessed up to 10 years ] [ Designated as safety issue: No ]

Enrollment: 305
Study Start Date: December 2008
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (THL)
Patients receive trastuzumab IV over 30-90 minutes and paclitaxel IV over 1 hour once weekly and lapatinib ditosylate PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.
Drug: lapatinib ditosylate
Given PO
Other Names:
  • GSK572016
  • GW-572016
  • GW2016
  • Lapatinib
  • Tykerb
Biological: trastuzumab
Given IV
Other Names:
  • anti-c-erB-2
  • Herceptin
  • MOAB HER2
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Other: laboratory biomarker analysis
Correlative studies
Active Comparator: Arm II (TH)
Patients receive trastuzumab and paclitaxel as in arm I.
Biological: trastuzumab
Given IV
Other Names:
  • anti-c-erB-2
  • Herceptin
  • MOAB HER2
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm III (TL)
Patients receive paclitaxel and lapatinib ditosylate as in arm I. (Discontinued as of 6-15-11)
Drug: lapatinib ditosylate
Given PO
Other Names:
  • GSK572016
  • GW-572016
  • GW2016
  • Lapatinib
  • Tykerb
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol

Detailed Description:

PRIMARY OBJECTIVE:

I. To determine if the pathologic complete response (pCR) in the breast to neoadjuvant weekly paclitaxel with trastuzumab plus lapatinib (THL) is 20% greater than the pCR to weekly paclitaxel with trastuzumab alone (TH).

SECONDARY OBJECTIVES:

I.To determine the pathologic complete response in the breast and axilla, using AJCC TMN criteria (Version 6), to neoadjuvant weekly paclitaxel plus HER2- targeted therapy in patients with HER2-positive operable breast cancer.

II. To evaluate residual cancer burden (RCB) as a predictor of long term relapse free survival (RFS) and overall survival (OS).

III. To document the toxicity of all chemotherapeutic regimens (THL, TH). IV. To determine the correlation between clinical, radiographic and pathologic response.

V. To compare overall survival (OS), relapse free survival (RFS) and time to first failure (TFF) among the treatment groups. OS and TFF will be measured for all patients from study registration. RFS will be measured from definitive surgery for those patients who undergo definitive surgery.

VI. To obtain blood, fresh frozen and fixed tumor tissue to test specific hypotheses for which biomarker data exist and to evaluate biomarkers in blood, serum and tissue that are likely to influence response to and toxicity of trastuzumab alone or trastuzumab plus lapatinib, when given with paclitaxel.

VII. To determine the surgical practice patterns for breast conservation and sentinel lymphadenectomy in patients undergoing neoadjuvant chemotherapy.

VIII. To determine the radiotherapy practice patterns for post-mastectomy and regional nodal irradiation in patients undergoing neoadjuvant chemotherapy.

IX. To evaluate pharmacogenomic determinants of toxicity.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive trastuzumab IV over 30-90 minutes and paclitaxel IV over 1 hour once weekly and lapatinib ditosylate orally (PO) once daily for 16 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive trastuzumab and paclitaxel as in arm I.

ARM III: Patients receive paclitaxel and lapatinib ditosylate as in arm I. (Discontinued as of 6-15-11) Within 42 days after completion of neoadjuvant therapy, patients in both arms undergo definitive surgery (breast conservation or total mastectomy).

After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 10 years.

  Eligibility

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

Inclusion Criteria:

  • Pathologically confirmed invasive breast cancer by core needle or incisional biopsy

    • Clinical stage II or III disease
    • Resectable disease
  • HER2- positive tumor, defined as 3+ over expression by immunohistochemistry (IHC) or gene amplification by fluorescence in situ hybridization (FISH) with a ratio of >= 2 on invasive tumor
  • Measurable disease, defined as target lesion in the breast >= 1 cm by physical examination or radiographic measurement

    • No axillary disease only
  • Multicentric or bilateral disease allowed provided the target lesion meets eligibility criteria
  • Planning to undergo surgical resection after neoadjuvant therapy
  • No inflammatory breast cancer
  • No metastatic disease
  • Concurrent enrollment in CALGB-150702 required
  • Hormone receptor status known
  • Menopausal status not specified
  • Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
  • Absolute neutrophil count (ANC) >= 1,000/mm^3
  • Platelet count >= 100,000/mm^3
  • Bilirubin =< 1.5 times upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times ULN
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective non-hormonal contraception during and for >= 2 months after completion of study treatment
  • Cardiac ejection fraction >= 50% by echocardiogram or multiple gated acquisition (MUGA) scan
  • Willing to undergo pretreatment biopsies and submit archival tissue obtained at the time of surgery
  • No concurrent pegfilgrastim
  • No prior chemotherapy, hormonal therapy, biologic therapy, or radiotherapy for the treatment of breast cancer
  • No other concurrent chemotherapy or hormonal therapy, except for the following:

    • Steroids for adrenal failure
    • Hormones for non-disease-related conditions (e.g., insulin for diabetes)
    • Intermittent use of dexamethasone as an antiemetic
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770809

  Hide Study Locations
Locations
United States, Arizona
University of Arizona Health Sciences Center
Tucson, Arizona, United States, 85724
United States, Arkansas
Sparks Regional Medical Center
Fort Smith, Arkansas, United States, 72901
United States, California
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, United States, 91505
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States, 94546
Eden Hospital Medical Center
Castro Valley, California, United States, 94546
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States, 94538
Contra Costa Regional Medical Center
Martinez, California, United States, 94553-3156
El Camino Hospital
Mountain View, California, United States, 94040
Palo Alto Medical Foundation-Camino Division
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
Highland General Hospital
Oakland, California, United States, 94602
Bay Area Tumor Institute CCOP
Oakland, California, United States, 94609
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
Tom K Lee Inc
Oakland, California, United States, 94609
Desert Regional Medical Center
Palm Springs, California, United States, 92262
Palo Alto Medical Foundation Heath Care
Palo Alto, California, United States, 94301
Valley Care Health System - Pleasanton
Pleasanton, California, United States, 94588
Valley Medical Oncology Consultants
Pleasanton, California, United States, 94588
University of California at Davis Cancer Center
Sacramento, California, United States, 95817
Saint Helena Hospital
Saint Helena, California, United States, 94574
Salinas Valley Memorial
Salinas, California, United States, 93901
San Francisco General Hospital
San Francisco, California, United States, 94110
UCSF-Mount Zion
San Francisco, California, United States, 94115
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, United States, 94806
United States, Colorado
The Medical Center of Aurora
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States, 80907
Colorado Cancer Research Program CCOP
Denver, Colorado, United States, 80224-2522
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
Exempla Saint Joseph Hospital
Denver, Colorado, United States, 80218
Swedish Medical Center
Englewood, Colorado, United States, 80113
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Saint Anthony Hospital
Lakewood, Colorado, United States, 80228
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 Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
Manchester Memorial Hospital
Manchester, Connecticut, United States, 06040
Middlesex Hospital
Middletown, Connecticut, United States, 06457
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
United States, Florida
Halifax Health Medical Center-Centers for Oncology
Daytona Beach, Florida, United States, 32114
Holy Cross Hospital
Fort Lauderdale, Florida, United States, 33308
Jupiter Medical Center
Jupiter, Florida, United States, 33458
Mount Sinai Medical Center CCOP
Miami Beach, Florida, United States, 33140
Cleveland Clinic Florida - Weston
Weston, Florida, United States, 33331
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Atlanta Regional CCOP
Atlanta, Georgia, United States, 30342
Northside Hospital
Atlanta, Georgia, United States, 30342
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342
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
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30045
Medical Center of Central Georgia
Macon, Georgia, United States, 31208
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
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
University of Chicago
Chicago, Illinois, United States, 60637
University of Illinois
Chicago, Illinois, United States, 60612
Mount Sinai Hospital Medical Center
Chicago, Illinois, United States, 60608
Resurrection Healthcare
Chicago, Illinois, United States, 60631
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Hematology Oncology Consultants Limited
Naperville, Illinois, United States, 60540
Advocate Christ Medical Center
Oak Lawn, Illinois, United States, 60453-2699
Swedish American Hospital
Rockford, Illinois, United States, 61104
United States, Indiana
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States, 46845
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Hematology Oncology Associates-Quad Cities
Bettendorf, Iowa, United States, 52722
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Capitol
Des Moines, Iowa, United States, 50307
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
United States, Kansas
Hays Medical Center
Hays, Kansas, United States, 67601
Promise Regional Medical Center-Hutchinson
Hutchinson, Kansas, United States, 65702
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, United States, 66762
Salina Regional Health Center
Salina, Kansas, United States, 67401
Saint Francis Hospital and Medical Center - Topeka
Topeka, Kansas, United States, 66606
Stormont-Vail Regional Health Center
Topeka, Kansas, United States, 66604
United States, Maine
Harold Alfond Center for Cancer Care
Augusta, Maine, United States, 04330
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
United States, Maryland
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
Peninsula Regional Medical Center
Salisbury, Maryland, United States, 21801
Holy Cross Hospital
Silver Spring, Maryland, United States, 20910
United States, Massachusetts
Sturdy Memorial Hospital
Attleboro, Massachusetts, United States, 02703
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Caritas Saint Elizabeth's Medical Center
Brighton, Massachusetts, United States, 02135-2997
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
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Oakwood Hospital
Dearborn, Michigan, United States, 48124
Saint John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States, 48532
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Allegiance Health
Jackson, Michigan, United States, 49201
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
Sparrow Hospital
Lansing, Michigan, United States, 48912
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States, 48341-2985
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Saint Mary's of Michigan
Saginaw, Michigan, United States, 48601
Providence Hospital
Southfield, Michigan, United States, 48075
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States, 48093
United States, Minnesota
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, United States, 56001
United States, Missouri
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Southeast Missouri Hospital
Cape Girardeau, Missouri, United States, 63701
Capital Region Medical Center-Goldschmidt Cancer Center
Jefferson City, Missouri, United States, 65109
Truman Medical Center
Kansas City, Missouri, United States, 64108
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Center for Cancer Care and Research
Saint Louis, Missouri, United States, 63141
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Comprehensive Cancer Care PC
Saint Louis, Missouri, United States, 63141
United States, Montana
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies PC
Billings, Montana, United States, 59102
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Billings Clinic
Billings, Montana, United States, 59107-7000
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
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States, 59405
Big Sky Oncology
Great Falls, Montana, United States, 59405
Northern Montana Hospital
Havre, Montana, United States, 59501
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Community Medical Hospital
Missoula, Montana, United States, 59801
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Montana Cancer Specialists
Missoula, Montana, United States, 59802
United States, Nebraska
Nebraska Cancer Research Center
Lincoln, Nebraska, United States, 68510
Alegent Health Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Creighton University Medical Center
Omaha, Nebraska, United States, 68131
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Missouri Valley Cancer Consortium CCOP
Omaha, Nebraska, United States, 68106
Alegent Health Lakeside Hospital
Omaha, Nebraska, United States, 68130
United States, Nevada
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States, 89106
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Renown Regional Medical Center
Reno, Nevada, United States, 89502
United States, New Hampshire
New Hampshire Oncology-Hematology PA
Concord, New Hampshire, United States, 03301
New Hampshire Oncology Hematology Associates
Hooksett, New Hampshire, United States, 03106
Cheshire Medical Center-Dartmouth-Hitchcock Keene
Keene, New Hampshire, United States, 03431
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
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
UMDNJ - New Jersey Medical School
Newark, New Jersey, United States, 07103
Overlook Hospital
Summit, New Jersey, United States, 07902
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87106
University of New Mexico at Lovelace Medical Center
Albuquerque, New Mexico, United States, 87102
Hematology Oncology Associates
Albuquerque, New Mexico, United States, 87106
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Hematology Oncology Associates of Central New York PC-East Syracuse
East Syracuse, New York, United States, 13057
Elmhurst Hospital Center
Elmhurst, New York, United States, 11373
Queens Hospital Center
Jamaica, New York, United States, 11432
North Shore University Hospital
Manhasset, New York, United States, 11030
North Shore-LIJ Health System CCOP
Manhasset, New York, United States, 11030
Orange Regional Medical Center
Middletown, New York, United States, 10940
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
North Shore-LIJ Health System/Center for Advanced Medicine
New Hyde Park, New York, United States, 11040
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Vassar Brothers Medical Center
Poughkeepsie, New York, United States, 12601
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Mission Hospital-Memorial Campus
Asheville, North Carolina, United States, 28801
Cone Health Alamance Regional Medical Center
Burlington, North Carolina, United States, 27216
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Carolinas Medical Center - Northeast
Concord, North Carolina, United States, 28025
Duke University Medical Center
Durham, North Carolina, United States, 27710
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
East Carolina University
Greenville, North Carolina, United States, 27858
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
Marion L Shepard Cancer Center
Washington, North Carolina, United States, 27889
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
Saint Alexius Medical Center
Bismarck, North Dakota, United States, 58501
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
Cleveland Clinic Cancer Center Beachwood
Beachwood, Ohio, United States, 44122
Aultman Health Foundation
Canton, Ohio, United States, 44710
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
Grandview Hospital
Dayton, Ohio, United States, 45405
Dayton CCOP
Dayton, Ohio, United States, 45420
Blanchard Valley Hospital
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Cleveland Clinic Cancer Center Independence
Independence, Ohio, United States, 44131
Kettering Medical Center
Kettering, Ohio, United States, 45429
Saint Rita's Medical Center
Lima, Ohio, United States, 45801
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
University Hospitals Parma Medical Center
Parma, Ohio, United States, 44129
Cleveland Clinic Cancer Center-Strongsville
Strongsville, Ohio, United States, 44136
Cleveland Clinic Wooster Specialty Center
Wooster, Ohio, United States, 44691
United States, Oklahoma
Cancer Care Associates
Oklahoma City, Oklahoma, United States, 73120
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
The Regional Cancer Center
Erie, Pennsylvania, United States, 16505
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lewistown Hospital
Lewistown, Pennsylvania, United States, 17044
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, United States, 18840
Mount Nittany Medical Center
State College, Pennsylvania, United States, 16803
United States, Rhode Island
Kent County Hospital
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Roper Hospital
Charleston, South Carolina, United States, 29401
Greenville Health System Cancer Institute-Easley
Easley, South Carolina, United States, 29640
Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Butternut
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Faris
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Instutite/Greenville CCOP
Greenville, South Carolina, United States, 29615
Self Regional Healthcare
Greenwood, South Carolina, United States, 29646
Cancer Centers of the Carolinas-Greer Medical Oncology
Greer, South Carolina, United States, 29650
Greenville Health System Cancer Institute-Greer
Greer, South Carolina, United States, 29650
Greenville Health System Cancer Institute-Seneca
Seneca, South Carolina, United States, 29672
Greenville Health System Cancer Institute-Spartanburg
Spartanburg, South Carolina, United States, 29307
United States, Tennessee
Erlanger Medical Center
Chattanooga, Tennessee, United States, 37403
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, Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont, United States, 05602
University of Vermont
Burlington, Vermont, United States, 05401
United States, Virginia
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia, United States, 22408
Lynchburg Hematology-Oncology Clinic
Lynchburg, Virginia, United States, 24501
United States, Washington
Cancer Care Center at Island Hospital
Anacortes, Washington, United States, 98221
Auburn Regional Medical Center
Auburn, Washington, United States, 98001
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Harrison HealthPartners Hematology and Oncology-Bremerton
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
Columbia Basin Hematology and Oncology PLLC
Kennewick, Washington, United States, 99336
Evergreen Hospital Medical Center
Kirkland, Washington, United States, 98033
Skagit Valley Hospital
Mount Vernon, Washington, United States, 98274
Providence - Saint Peter Hospital
Olympia, Washington, United States, 98506-5166
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States, 98370
Good Samaritan Community Hospital
Puyallup, Washington, United States, 98372
University of Washington Medical Center
Seattle, Washington, United States, 98195
Virginia Mason CCOP
Seattle, Washington, United States, 98101
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
Pacific Medical Center-First Hill
Seattle, Washington, United States, 98104
The Polyclinic
Seattle, Washington, United States, 98122
Group Health Cooperative-Seattle
Seattle, Washington, United States, 98112
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Minor and James Medical PLLC
Seattle, Washington, United States, 98104
United General Hospital
Sedro-Woolley, Washington, United States, 98284
Evergreen Hematology and Oncology PS
Spokane, Washington, United States, 99218
Providence Holy Family Hospital
Spokane, Washington, United States, 99208
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Saint Clare Hospital
Tacoma, Washington, United States, 98499
Northwest CCOP
Tacoma, Washington, United States, 98405
Saint Joseph Medical Center
Tacoma, Washington, United States, 98405
Multicare Health System
Tacoma, Washington, United States, 98415
Allenmore Hospital
Tacoma, Washington, United States, 98405
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, West Virginia
Saint Mary's Medical Center
Huntington, West Virginia, United States, 25702
Camden-Clark Memorial Hospital
Parkersburg, West Virginia, United States, 26101
United States, Wisconsin
Gundersen Lutheran
La Crosse, Wisconsin, United States, 54601
United States, Wyoming
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Puerto Rico
San Juan City Hospital
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
Investigators
Principal Investigator: Lisa Carey Cancer and Leukemia Group B
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00770809     History of Changes
Other Study ID Numbers: NCI-2009-01073, NCI-2009-01073, CALGB-40601, CDR0000616648, CALGB 40601, CALGB-40601, P30CA014236, U10CA031946
Study First Received: October 9, 2008
Last Updated: May 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Neoplasms, Male
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Lapatinib
Paclitaxel
Trastuzumab
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 29, 2014