Male Breast CarcinomaPhase 3NCT00770809
Paclitaxel and Trastuzumab With or Without Lapatinib in Treating Patients With Stage II or Stage III Breast Cancer That Can Be Removed by Surgery
A Phase 3 study testing Laboratory Biomarker Analysis, Lapatinib Ditosylate and Paclitaxel in people with Male Breast Carcinoma and Stage IIA Breast Cancer AJCC v6 and v7, run by National Cancer Institute (NCI) at 318 sites in 2 countries.
Trial summary
This randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib to see how well they work in treating patients with stage II or stage III breast cancer that can be removed by surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Male Breast Carcinoma, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7
- What is being tested?
- Laboratory Biomarker Analysis, Lapatinib Ditosylate and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 318 sitesin 2 countries
- Study dates
- 24 Feb 2009to 15 Feb 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologic confirmation of invasive breast cancer; patients with inflammatory breast cancer are not eligible
- Clinical stage II-III operable invasive breast cancer with intent to perform surgical resection after neoadjuvant therapy
- Patients with multicentric or bilateral disease are eligible as long as the target lesion meets the eligibility criteria for this study
- Staging to rule out metastatic disease is recommended for clinical stage III patients
- Tumors must be HER2 positive defined as HER2 3+ by immunohistochemical (IHC) assays or gene amplification by fluorescence in situ hybridization (FISH) with a ratio of >= 2 on invasive tumor
- Estrogen receptor (ER) and progesterone receptor (PgR) status must be known
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- The target lesion in the breast must be >= 1 cm on physical examination or by radiographic measurement; palpable axillary adenopathy will be documented but not serve as measurable disease for the primary endpoint; patients with axillary disease only are not eligible to participate
- Patient agrees to provide pretreatment biopsies
- No prior chemotherapy, hormone therapy, biologic, or radiation therapy with therapeutic intent for this cancer
- Cardiac ejection fraction must be >= 50% by echocardiogram or multiple gated acquisition (MUGA) scan
- Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
- Patients must not be pregnant or nursing
- Absolute neutrophil count (ANC) >= 1,000/ul
- Platelet count >= 100,000/ul
- Bilirubin =< 1.5 times upper limit of normal
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 times upper limit of normal (ULN)
- Serum beta-human chorionic gonadotropin (HCG) negative (in female patients unless status-post (s/p) hysterectomy or menopausal or no menses for 24 consecutive months); assay must have a sensitivity of at least 50 mIU/mL
Who cannot join
None listed.
Trial locations and contacts
318 sites in 2 countries.
301 sites in 2 countries
United States300 sites
Cleveland Clinic Akron General
Akron, Ohio, 44307
Lovelace Medical Center-Saint Joseph Square
Albuquerque, New Mexico, 87102
Hematology Oncology Associates
Albuquerque, New Mexico, 87106
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87106
OSF Saint Anthony's Health Center
Alton, Illinois, 62002
McFarland Clinic - Ames
Ames, Iowa, 50010
Cancer Care Center at Island Hospital
Anacortes, Washington, 98221
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, 48106
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, 48106
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
Mission Hospital
Asheville, North Carolina, 28801
Piedmont Hospital
Atlanta, Georgia, 30309
Atlanta Regional CCOP
Atlanta, Georgia, 30342
Emory Saint Joseph's Hospital
Atlanta, Georgia, 30342
Northside Hospital
Atlanta, Georgia, 30342
Sturdy Memorial Hospital
Attleboro, Massachusetts, 02703
MultiCare Auburn Medical Center
Auburn, Washington, 98001
Harold Alfond Center for Cancer Care
Augusta, Maine, 04330
The Medical Center of Aurora
Aurora, Colorado, 80012
WellStar Cobb Hospital
Austell, Georgia, 30106
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201
Eastern Maine Medical Center
Bangor, Maine, 04401
Cleveland Clinic Cancer Center Beachwood
Beachwood, Ohio, 44122
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, 46107
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722
Billings Clinic Cancer Center
Billings, Montana, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101
Saint Vincent Healthcare
Billings, Montana, 59101
Montana Cancer Consortium NCORP
Billings, Montana, 59102
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102
Mid Dakota Clinic
Bismarck, North Dakota, 58501
Saint Alexius Medical Center
Bismarck, North Dakota, 58501
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina, 29316
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, 83706
Tufts Medical Center
Boston, Massachusetts, 02111
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Boulder Community Foothills Hospital
Boulder, Colorado, 80303
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715
Dana-Farber Cancer Institute at Boston Medical Center - Brighton
Brighton, Massachusetts, 02135
Roswell Park Cancer Institute
Buffalo, New York, 14263
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505
Highline Medical Center-Main Campus
Burien, Washington, 98166
Cone Health Cancer Center at Alamance Regional
Burlington, North Carolina, 27215
University of Vermont and State Agricultural College
Burlington, Vermont, 05405
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701
Cooper Hospital University Medical Center
Camden, New Jersey, 08103
Aultman Health Foundation
Canton, Ohio, 44710
Southeast Missouri Hospital
Cape Girardeau, Missouri, 63701
Mercy Cancer Center - Cape Girardeau
Cape Girardeau, Missouri, 63703
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703
East Bay Radiation Oncology Center
Castro Valley, California, 94546
Eden Hospital Medical Center
Castro Valley, California, 94546
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, 94546
Providence Regional Cancer System-Centralia
Centralia, Washington, 98531
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
Roper Hospital
Charleston, South Carolina, 29401
Erlanger Medical Center
Chattanooga, Tennessee, 37403
Mount Sinai Hospital Medical Center
Chicago, Illinois, 60608
University of Illinois
Chicago, Illinois, 60612
Presence Resurrection Medical Center
Chicago, Illinois, 60631
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637
Weiss Memorial Hospital
Chicago, Illinois, 60640
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, 50325
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, 80907
John B Amos Cancer Center
Columbus, Georgia, 31904
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301
Atrium Health Cabarrus/LCI-Concord
Concord, North Carolina, 28025
Danville Regional Medical Center
Danville, Virginia, 24541
Grandview Hospital
Dayton, Ohio, 45405
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406
Miami Valley Hospital
Dayton, Ohio, 45409
Miami Valley Hospital North
Dayton, Ohio, 45415
Dayton NCI Community Oncology Research Program
Dayton, Ohio, 45459
Halifax Health Medical Center-Centers for Oncology
Daytona Beach, Florida, 32114
Corewell Health Dearborn Hospital
Dearborn, Michigan, 48124
Emory Decatur Hospital
Decatur, Georgia, 30033
AdventHealth Porter
Denver, Colorado, 80210
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, 80218
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, 80218
Rose Medical Center
Denver, Colorado, 80220
Western States Cancer Research NCORP
Denver, Colorado, 80222
Mercy Capitol
Des Moines, Iowa, 50307
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, 50309
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, 50314
Iowa Lutheran Hospital
Des Moines, Iowa, 50316
Henry Ford Health Saint John Hospital
Detroit, Michigan, 48236
Advocate Good Samaritan Hospital
Downers Grove, Illinois, 60515
Duke University Medical Center
Durham, North Carolina, 27710
Prisma Health Cancer Institute - Easley
Easley, South Carolina, 29640
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057
Christiana Care - Union Hospital
Elkton, Maryland, 21921
Elmhurst Hospital Center
Elmhurst, New York, 11373
Bay Area Breast Surgeons Inc
Emeryville, California, 94608
Swedish Medical Center
Englewood, Colorado, 80113
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, 16505
Piedmont Fayette Hospital
Fayetteville, Georgia, 30214
Saint Francis Hospital
Federal Way, Washington, 98003
Blanchard Valley Hospital
Findlay, Ohio, 45840
Hurley Medical Center
Flint, Michigan, 48503
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, 48532
Holy Cross Hospital
Fort Lauderdale, Florida, 33308
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia, 22408
Valley Medical Oncology Consultants-Fremont
Fremont, California, 94538
Florida Cancer Specialists-Gainesville Cancer Center
Gainesville, Florida, 32605
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, 81501
Benefis Sletten Cancer Institute
Great Falls, Montana, 59405
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, 59405
Great Falls Clinic
Great Falls, Montana, 59405
Banner North Colorado Medical Center
Greeley, Colorado, 80631
East Carolina University
Greenville, North Carolina, 27834
Wayne Hospital
Greenville, Ohio, 45331
Greenville Health System Cancer Institute-Andrews
Greenville, South Carolina, 29601
Saint Francis Hospital
Greenville, South Carolina, 29601
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina, 29605
Prisma Health Cancer Institute - Faris
Greenville, South Carolina, 29605
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, 29605
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615
Self Regional Healthcare
Greenwood, South Carolina, 29646
Prisma Health Cancer Institute - Greer
Greer, South Carolina, 29650
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, 06105
Northern Montana Hospital
Havre, Montana, 59501
HaysMed
Hays, Kansas, 67601
Saint Peter's Community Hospital
Helena, Montana, 59601
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Saint Mary's Medical Center
Huntington, West Virginia, 25702
Hutchinson Regional Medical Center
Hutchinson, Kansas, 67502
Cleveland Clinic Cancer Center Independence
Independence, Ohio, 44131
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
Allegiance Health
Jackson, Michigan, 49201
Queens Hospital Center
Jamaica, New York, 11432
MU Health Care Goldschmidt Cancer Center
Jefferson City, Missouri, 65109
Duly Health and Care Joliet
Joliet, Illinois, 60435
Jupiter Medical Center
Jupiter, Florida, 33458
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, 49007
Beacon Kalamazoo
Kalamazoo, Michigan, 49048
Glacier Oncology PLLC
Kalispell, Montana, 59901
Kalispell Medical Oncology
Kalispell, Montana, 59901
Logan Health Medical Center
Kalispell, Montana, 59901
University of Kansas Cancer Center
Kansas City, Kansas, 66160
University Health Truman Medical Center
Kansas City, Missouri, 64108
Cheshire Medical Center-Dartmouth-Hitchcock Keene
Keene, New Hampshire, 03431
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336
Kettering Medical Center
Kettering, Ohio, 45429
ECU Health Oncology Kinston
Kinston, North Carolina, 28501
EvergreenHealth Medical Center
Kirkland, Washington, 98033
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
LRGHealthcare-Lakes Region General Hospital
Laconia, New Hampshire, 03246
Northwell Health NCORP
Lake Success, New York, 11042
Northwell Health/Center for Advanced Medicine
Lake Success, New York, 11042
Saint Anthony Hospital
Lakewood, Colorado, 80228
Saint Clare Hospital
Lakewood, Washington, 98499
University of Michigan Health - Sparrow Lansing
Lansing, Michigan, 48912
Doctor's Hospital of Laredo
Laredo, Texas, 78041
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada, 89120
Northside Hospital - Gwinnett
Lawrenceville, Georgia, 30046
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Beebe Medical Center
Lewes, Delaware, 19958
Lewistown Hospital
Lewistown, Pennsylvania, 17044
Saint Rita's Medical Center
Lima, Ohio, 45801
Nebraska Cancer Research Center
Lincoln, Nebraska, 68510
AdventHealth Littleton
Littleton, Colorado, 80122
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, 48154
Sky Ridge Medical Center
Lone Tree, Colorado, 80124
Longmont United Hospital
Longmont, Colorado, 80501
Banner McKee Medical Center
Loveland, Colorado, 80539
Texas Tech University Health Sciences Center-Lubbock
Lubbock, Texas, 79430
Centra Alan B Pearson Regional Cancer Center
Lynchburg, Virginia, 24501
Atrium Health Navicent
Macon, Georgia, 31201
Manchester Memorial Hospital
Manchester, Connecticut, 06040
Dartmouth Cancer Center - Manchester
Manchester, New Hampshire, 03102
Elliot Hospital
Manchester, New Hampshire, 03103
Solinsky Center for Cancer Care
Manchester, New Hampshire, 03103
North Shore University Hospital
Manhasset, New York, 11030
Mayo Clinic Health Systems-Mankato
Mankato, Minnesota, 56001
Wellstar Kennestone Hospital
Marietta, Georgia, 30060
Contra Costa Regional Medical Center
Martinez, California, 94553-3156
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, 44124
Loyola University Medical Center
Maywood, Illinois, 60153
Mount Sinai Medical Center
Miami Beach, Florida, 33140
Middlesex Hospital
Middletown, Connecticut, 06457
Garnet Health Medical Center
Middletown, New York, 10940
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Milford, Massachusetts, 01757
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
Milwaukee, Wisconsin, 53210
Montana Cancer Specialists
Missoula, Montana, 59802
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802
Community Medical Center
Missoula, Montana, 59804
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804
Morristown Medical Center
Morristown, New Jersey, 07960
SSM Health Good Samaritan
Mount Vernon, Illinois, 62864
Skagit Valley Hospital
Mount Vernon, Washington, 98274
El Camino Hospital
Mountain View, California, 94040
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040
Foundation Medical Partners
Nashua, New Hampshire, 03060
Nashville Oncology Associates PC
Nashville, Tennessee, 37203
Meharry Medical College
Nashville, Tennessee, 37208
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718
Rutgers New Jersey Medical School
Newark, New Jersey, 07101
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453-2699
Wilma Chan Highland Hospital
Oakland, California, 94602
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609
Bay Area Tumor Institute
Oakland, California, 94609
Hematology and Oncology Associates-Oakland
Oakland, California, 94609
Tom K Lee Inc
Oakland, California, 94609
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Cancer Care Associates
Oklahoma City, Oklahoma, 73120
Providence - Saint Peter Hospital
Olympia, Washington, 98506-5166
Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122
Alegent Health Bergan Mercy Medical Center
Omaha, Nebraska, 68124
Alegent Health Lakeside Hospital
Omaha, Nebraska, 68130
Creighton University Medical Center
Omaha, Nebraska, 68131
Desert Regional Medical Center
Palm Springs, California, 92262
Palo Alto Medical Foundation Health Care
Palo Alto, California, 94301
AdventHealth Parker
Parker, Colorado, 80138
Camden Clark Medical Center
Parkersburg, West Virginia, 26101
University Hospitals Parma Medical Center
Parma, Ohio, 44129
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374
Mercy Hospital Pittsburg
Pittsburg, Kansas, 66762
Valley Care Health System - Pleasanton
Pleasanton, California, 94588
Valley Medical Oncology Consultants
Pleasanton, California, 94588
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, 48341
Lake Huron Medical Center
Port Huron, Michigan, 48060
Vassar Brothers Medical Center
Poughkeepsie, New York, 12601
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, 98370
Saint Mary Corwin Medical Center
Pueblo, Colorado, 81004
MultiCare Good Samaritan Hospital
Puyallup, Washington, 98372
UNC Rex Healthcare
Raleigh, North Carolina, 27607
Renown Regional Medical Center
Reno, Nevada, 89502
Reid Health
Richmond, Indiana, 47374
Southern Regional Medical Center
Riverdale, Georgia, 30274
Swedish American Hospital
Rockford, Illinois, 61104
Harbin Clinic Medical Oncology and Clinical Research
Rome, Georgia, 30165
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817
MyMichigan Medical Center Saginaw
Saginaw, Michigan, 48601
Salina Regional Health Center
Salina, Kansas, 67401
Salinas Valley Memorial
Salinas, California, 93901
TidalHealth Peninsula Regional
Salisbury, Maryland, 21801
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110
UCSF Medical Center-Mount Zion
San Francisco, California, 94115
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, 94806
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, 31405
Guthrie Medical Group PC-Robert Packer Hospital
Sayre, Pennsylvania, 18840
Virginia Mason Medical Center
Seattle, Washington, 98101
Minor and James Medical PLLC
Seattle, Washington, 98104
Pacific Medical Center-First Hill
Seattle, Washington, 98104
Kaiser Permanente Washington
Seattle, Washington, 98112
Swedish Medical Center-First Hill
Seattle, Washington, 98122
University of Washington Medical Center - Montlake
Seattle, Washington, 98195
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina, 29672
Welch Cancer Center
Sheridan, Wyoming, 82801
Holy Cross Hospital
Silver Spring, Maryland, 20910
Saint Michael Cancer Center
Silverdale, Washington, 98383
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51102
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104
Henry Ford Health Providence Southfield Hospital
Southfield, Michigan, 48075
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204
Providence Holy Family Hospital
Spokane, Washington, 99208
Evergreen Hematology and Oncology PS
Spokane, Washington, 99218
Mercy Infusion Center - Chippewa
St Louis, Missouri, 63109
Washington University School of Medicine
St Louis, Missouri, 63110
Missouri Baptist Medical Center
St Louis, Missouri, 63131
Center for Cancer Care and Research
St Louis, Missouri, 63141
Comprehensive Cancer Care PC
St Louis, Missouri, 63141
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, 63141
Saint Helena Hospital
St. Helena, California, 94574
Mount Nittany Medical Center
State College, Pennsylvania, 16803
Cleveland Clinic Cancer Center Strongsville
Strongsville, Ohio, 44136
Overlook Hospital
Summit, New Jersey, 07902
State University of New York Upstate Medical University
Syracuse, New York, 13210
MultiCare Allenmore Hospital
Tacoma, Washington, 98405
MultiCare Tacoma General Hospital
Tacoma, Washington, 98405
Northwest NCI Community Oncology Research Program
Tacoma, Washington, 98405
Saint Joseph Medical Center
Tacoma, Washington, 98405
About this study
Official title: Randomized Phase III Trial of Paclitaxel +Trastuzumab + Lapatinib Versus Paclitaxel + Trastuzumab as Neoadjuvant Treatment of HER2-Positive Primary Breast Cancer
This randomized phase III trial studies paclitaxel and trastuzumab with or without lapatinib to see how well they work 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, by stopping them from dividing, or by stopping them from spreading. 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 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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- To determine the pathologic complete response in the breast and axilla, using American Joint Committee on Cancer (AJCC) Tumor, Lymph Nodes and Metastasis (TMN) criteria (version 6), to neoadjuvant weekly paclitaxel plus human epidermal growth factor 2 (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.
- To compare overall survival (OS), relapse free survival (RFS) and time to first failure (TFF) among the treatment groups.
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.
- Conditions
- Male Breast Carcinoma, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7
- Being tested
- Laboratory Biomarker Analysis, Lapatinib Ditosylate, Paclitaxel, Trastuzumab
- Medical subject headings
- Breast Neoplasms, Male, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Lapatinib DitosylateDrug
Also called Tykerb
Given PO
PaclitaxelDrug
Also called Anzatax, Asotax, Bristaxol, Praxel
Given IV
TrastuzumabBiological
Also called ABP 980, ALT02, Biceltis, CANMab
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Arm I (THL) | Experimental | Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 750 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. Receives: Other: Laboratory Biomarker Analysis; Drug: Lapatinib Ditosylate; Drug: Paclitaxel; Biological: Trastuzumab |
| Arm II (TH) | Active comparator | Patients receive trastuzumab 2 mg/kg IV over 30-90 minutes and paclitaxel 80 mg/m^2 IV over 1 hour once weekly for 16 weeks in the absence of disease progression or unacceptable toxicity. Receives: Other: Laboratory Biomarker Analysis; Drug: Paclitaxel; Biological: Trastuzumab |
| Arm III (TL) | Experimental | Patients receive paclitaxel 80 mg/m^2 IV over 1 hour once weekly and lapatinib ditosylate 15000 mg PO once daily for 16 weeks in the absence of disease progression or unacceptable toxicity. (Discontinued as of 6-15-11) Receives: Drug: Lapatinib Ditosylate; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR Rate
Complete pathological response is defined as the absence of residual invasive carcinoma in the breast at the time of definitive surgical removal. Pathologic complete response in the lymph nodes is defined as no detectable invasive tumor by H\&E. Analysis will use a chi-square test for the difference in proportions of patients on the THL arm versus the TH arm who achieve a pCR. Exact binomial methods will be used to construct 95% confidence intervals around the pCR incidence for each arm.
Measured: At time of surgery
Secondary outcomes (6)
Pathologic Stage in the Breast and Axilla
Stage will be determined by the American Joint Committee on Cancer (AJCC) TNM (tumor, lymph nodes, metastasis) staging system. yT0: No evidence of residual invasive primary tumor. yTis: Carcinoma in situ only (presence of ductal carcinoma in situ [DCIS] but completely free of invasive cancer). yT1: Residual invasive tumor <= 2 in greatest dimension.yT2: Residual invasive tumor > 2 cm but <= 5 cm in greatest dimension.yT3: Residual invasive tumor > 5 cm in greatest dimension.yT4: Residual tumor of any size with direct extension to the chest wall and/or skin (including ulceration or macroscopic nodules).
Measured: At time of surgery
Radiographic Response Rate (at Completion of Neoadjuvant Therapy)
Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a complete response (disappearance of all target lesions) or partial response (30% decrease in sum of longest diameter of target lesions).
Measured: Week 16
Overall Survival Rate
Overall survival was measured as the interval from study entry until death, from any cause, or last contact. Distribution was estimated using the Kaplan Meier product-limit method
Measured: Time from randomization to death or last follow-up (up to 10 years)
Relapse-free Survival (RFS) Rate
Relapse free survival is defined as the interval from definitive surgery to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, or death from any cause, whichever occurs first. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Patients who do not undergo definitive surgery will not be assessable for RFS. Distribution was estimated using the Kaplan Meier product-limit method. Relapse-free survival (RFS) Rate is the rate of patients alive and relapse free.
Measured: Time from surgery to any recurrence (up to 10 years)
Time to First Failure
Time to first failure is defined as the interval from study entry to ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence or death from any cause. Patients who have not experienced any of these events will be censored at the date of last clinical assessment. Distribution was estimated using the Kaplan Meier product-limit method.
Measured: Time from surgery to any recurrence (up to 10 years)
Incidence of Adverse Events as Graded by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 3
The type and grade of treatment-related toxicity will be tabulated by treatment arm.
Measured: Up to 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study start24 Feb 2009
- Primary completion31 Jan 2014
- Study completion15 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Male Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lisa A Carey, Principal investigator, Alliance for Clinical Trials in Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770809
- Sponsor's protocol ID
- NCI-2009-01073
- Other IDs
- NCI-2009-01073, CDR0000616648, CALGB 40601, CALGB-40601, U10CA180821, U10CA031946
- Status last verified
- Jul 2026
- First submitted
- 9 Oct 2008
- Last updated
- 12 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Jaehnig EJ, Fernandez-Martinez A, Vashist TD, Holt MV, Williams L, Lei JT, Moon CI, Kim BJ, Dou Y, Zhao H, Korchina V, Gibbs RA, Muzny DM, Doddapaneni H, Perou CM, Carey LA, Robles AI, Hyslop T, Wen Y, McCart L, Krek A, Petralia F, Miles G, Kavuri SM, Gillette MA, Mani DR, Carr SA, Zhang B, Ellis MJ, Satpathy S, Anurag M. Proteogenomic analysis of the CALGB 40601 (Alliance) HER2+ breast cancer neoadjuvant trial reveals resistance biomarkers. Cell Rep Med. 2025 Jun 17;6(6):102154. doi: 10.1016/j.xcrm.2025.102154. Epub 2025 Jun 5.
PubMed 40480221Fernandez-Martinez A, Krop IE, Hillman DW, Polley MY, Parker JS, Huebner L, Hoadley KA, Shepherd J, Tolaney S, Henry NL, Dang C, Harris L, Berry D, Hahn O, Hudis C, Winer E, Partridge A, Perou CM, Carey LA. Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance), a Neoadjuvant Phase III Trial of Paclitaxel-Trastuzumab With or Without Lapatinib in HER2-Positive Breast Cancer. J Clin Oncol. 2020 Dec 10;38(35):4184-4193. doi: 10.1200/JCO.20.01276. Epub 2020 Oct 23.
PubMed 33095682Carey LA, Berry DA, Cirrincione CT, Barry WT, Pitcher BN, Harris LN, Ollila DW, Krop IE, Henry NL, Weckstein DJ, Anders CK, Singh B, Hoadley KA, Iglesia M, Cheang MC, Perou CM, Winer EP, Hudis CA. Molecular Heterogeneity and Response to Neoadjuvant Human Epidermal Growth Factor Receptor 2 Targeting in CALGB 40601, a Randomized Phase III Trial of Paclitaxel Plus Trastuzumab With or Without Lapatinib. J Clin Oncol. 2016 Feb 20;34(6):542-9. doi: 10.1200/JCO.2015.62.1268. Epub 2015 Nov 2.
PubMed 26527775