Capecitabine and Lapatinib Ditosylate With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB-IV Breast Cancer
NCT ID: NCT00684983
Last Updated: 2020-03-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
64 participants
INTERVENTIONAL
2008-07-30
2019-10-15
Brief Summary
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Detailed Description
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I. To compare progression-free survival of HER2+ breast cancer patients randomized to receive lapatinib ditosylate (lapatinib) and capecitabine +/- cixutumumab (IMC-A12).
SECONDARY OBJECTIVES:
I. To assess the safety and tolerability of lapatinib and capecitabine +/- IMC-A12 in HER2+ breast cancer patients.
II. To compare the overall survival time, time to treatment failure, confirmed tumor response rate, and duration of response of lapatinib and capecitabine +/- IMC-A12 in HER2+ breast cancer patients.
III. To assess patient compliance per treatment arm and to compare overall quality of life and treatment side effects via patient-reported outcomes between treatment arms.
TRANSLATIONAL RESEARCH OBJECTIVES:
I. To determine the role of the following in predicting response to lapatinib and capecitabine +/- IMC-A12:
Ia. Expression patterns and/or activation IGF- and ErbB family of receptors and signaling molecules in formalin-fixed, paraffin-embedded breast tumor tissue.
Ib. Expression patterns and/or activation IGF- and ErbB receptors and signaling molecules in circulating tumor cells from breast cancer patients.
Ic. Changes in expression patterns and/or activation IGF- and ErbB receptors and signaling molecules following treatment with lapatinib and capecitabine +/- IMC-A12 in circulating tumor cells from breast cancer patients.
Id. Expression patterns of IGF-1, IGF-II, insulin, growth hormone, and the IGF binding proteins in the serum of breast cancer patients.
Ie. Changes in expression patterns of IGF-1, IGF-II, insulin, growth hormone, and the IGF binding proteins in the serum of breast cancer patients.
II. Banking of paraffin-embedded tissue blocks/slides and blood products (i.e., serum, plasma, and buffy coat) for future studies.
III. To assess the proportion of patients whose pathologic specimens were correctly diagnosed as HER2 positive (according to 2007 American Society of Clinical Oncology \[ASCO\] College of American Pathologist \[CAP\] guidelines) metastatic breast cancer.
OUTLINE: The first 10 patients enrolled on this study are assigned to cohort I (safety analysis). All other patients are assigned to cohort II (randomized treatment).
COHORT I (SAFETY ANALYSIS, closed to accrual): Patients receive cixutumumab intravenously (IV) over 1 hour on days 1, 8, and 15. Patients also receive capecitabine orally (PO) twice daily (BID) on days 1-14 and lapatinib ditosylate PO once daily (QD) on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
COHORT II (RANDOMIZED TREATMENT): Patients are randomized to 1 of 2 treatment arms.
ARM A: Patients receive capecitabine PO BID on days 1-14 and lapatinib ditosylate PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive capecitabine and lapatinib ditosylate as in Arm A. Patients also receive cixutumumab IV over 1 hour on days 1, 8, and 15. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months until disease progression and then every 6 months for up to 5 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A (lapatinib ditosylate, capecitabine)
Patients receive capecitabine PO BID on days 1-14 and lapatinib ditosylate PO QD on days 1-21. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine
Given PO
Lapatinib Ditosylate
Given PO
Quality-of-Life Assessment
Ancillary studies
Arm B (cixutumumab, lapatinib ditosylate, capecitabine)
Patients receive capecitabine and lapatinib ditosylate as in Arm A. Patients also receive cixutumumab IV over 1 hour on days 1, 8, and 15. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Capecitabine
Given PO
Cixutumumab
Given IV
Lapatinib Ditosylate
Given PO
Quality-of-Life Assessment
Ancillary studies
Interventions
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Capecitabine
Given PO
Cixutumumab
Given IV
Lapatinib Ditosylate
Given PO
Quality-of-Life Assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* NOTE: Agents need not have been given concurrently, nor in the same regimen
* NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment
* Pre-treatment requirements:
* Prior treatment with trastuzumab in the neo-adjuvant, adjuvant or metastatic setting is required
* NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment
* NOTE: Concomitant use of trastuzumab is not allowed in this study
* Prior chemotherapy allowed in the neo-adjuvant, adjuvant, or metastatic setting; unlimited prior chemotherapy is allowed
* Prior hormonal therapy allowed in the neo-adjuvant, adjuvant, or metastatic setting; unlimited prior hormonal therapy is allowed
* HER2 positive, defined as:
* Validated immunohistochemistry (IHC) assay score of 3+ (defined as uniform, intense staining of \> 30% of invasive tumor cells)
* -OR- Average HER2 gene copy number of \> 6
* -OR- Gene amplified (HER2:D17Z1 ratio \> 2.20)
* Must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only
* Hemoglobin \> 9.0 g/dL (obtained =\< 7 days prior to registration)
* White blood cells (WBC) \>= 3,000/mL (obtained =\< 7 days prior to registration)
* Absolute neutrophil count (ANC) \>= 1500/mL (obtained =\< 7 days prior to registration)
* Platelet count \>= 75,000/mL (obtained =\< 7 days prior to registration)
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) (obtained =\< 7 days prior to registration)
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 2.5 x ULN or SGOT (AST) and SGPT (ALT) =\< 5 x ULN if elevations are due to liver metastases (obtained =\< 7 days prior to registration)
* Serum creatinine =\< 1.5 x ULN (obtained =\< 7 days prior to registration)
* Creatinine clearance \>= 30 mL/min (calculated according to Cockcroft and Gault) (obtained =\< 7 days prior to registration)
* NOTE: In patients with moderate renal impairment (calculated creatinine clearance 30-50 mL/min) at baseline, a dose reduction of the capecitabine starting dose is required
* Fasting glucose \< 120 mg/dL (obtained =\< 7 days prior to registration)
* NOTE: Patients with diabetes are allowed to participate, provided that their blood glucose is within the guidelines above upon enrollment
* International normalization ratio (INR) =\< 1.5 x ULN (obtained =\< 7 days prior to registration)
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2
* Adequate cardiac function defined as an ejection fraction \>= 50% as determined by multi gated acquisition scan (MUGA) or echocardiogram
* Life expectancy \> 3 months
* Has written informed consent been obtained?
* Willingness to return to a North Central Cancer Treatment Group (NCCTG) or other participating cooperative group institution for treatment and follow-up
* Patient willing to provide tissue and blood samples for research purposes
* Availability of diagnostic material (i.e., diagnostic slides confirming locally advanced/metastatic disease and HER2 stained slides) and operative and pathology reports from diagnosis of locally advanced or metastatic breast cancer
* NOTE: Biopsy of recurrent disease and submission of these materials is not required if materials available from initial diagnosis of locally advanced/metastatic disease
* Ability to complete questionnaire(s) by themselves or with assistance
Exclusion Criteria
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician)
* Stage III or IV invasive cancer, other than breast cancer, in =\< 5 years prior to registration
* Actively being treated for other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix; if there is a history of prior malignancy, patient must not be receiving other specific treatment for their cancer
* New York Heart Association class III or IV cardiovascular disease
* Current, active hepatic or biliary disease except Gilbert's syndrome or asymptomatic gallstones
* Evidence of active brain metastasis including leptomeningeal involvement; central nervous system (CNS) metastasis controlled by prior surgery and/or radiotherapy is allowed
* NOTE: To be considered controlled, there must be at least 2 months of no symptoms or evidence of progression prior to study entry and corticosteroid therapy must have been discontinued
* Major surgery, chemotherapy, or immunologic therapy =\< 4 weeks prior to registration
* Radiotherapy =\< 4 weeks prior to registration, except if to a non-target lesion only; prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed; if patient receives single dose radiation for palliation or radiation to non-target lesion, they may immediately proceed to registration without waiting; acute adverse events from radiation must have resolved to =\< Common Terminology Criteria for Adverse Events (CTCAE) version (v) 3.0 grade 1
* Prior treatment with any therapy targeting IGF-I, IGF-II or its receptors (either monoclonal antibody or tyrosine kinase inhibitor), including but not limited to any of the following (which would have been received on a previous clinical trial):
* IMC-A12 (cixutumumab)
* CP-751,871 (figitumumab)
* AMG-479
* INSM-18
* MK0646 (h7C10)
* SCH717454 (19D12, robatumumab)
* R1507
* OSI-906
* BMS-754807
* PPP
* NVP-AEW541
* AVE-1642
* MEDI-573
* Prior therapy with any therapy targeting HER1 (EGFR) and/or HER2 (either monoclonal antibody or tyrosine kinase) other than trastuzumab, including but not limited to any of the following:
* Lapatinib (Tykerb)
* Gefitinib (Iressa)
* Erlotinib (Tarceva)
* Cetuximab (Erbitux)
* Panitumumab (Vectibix)
* Currently receiving treatment with any agents that are contraindicated by study therapies:
* IMC-A12 - none identified to date
* Lapatinib - CYP3A4 inhibitors and inducers, including grapefruit and grapefruit juice
* Capecitabine - warfarin (Coumadin), cimetidine (Tagamet), allopurinol (Lopurin), sorivudine (Usevir) or brivudine (Brivex), ketoconazole (Nizoral), itraconazole (Sporanox), ritonavir (Norvir), amprenavir (Agenerase) or indinavir (Crixivan)
* Uncontrolled intercurrent illness including, but not limited to:
* Poorly controlled diabetes
* Ongoing or active infection
* Symptomatic congestive heart failure
* Unstable angina pectoris
* Cardiac arrhythmia
* Psychiatric illness/social situations that would limit compliance with study requirements
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the safety of the prescribed regimens
* Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered
* Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive with an acquired immune deficiency syndrome (AIDS)-defining illness; HIV positive patients with cluster of differentiation (CD) 4 count within institutional normal range and no history of an AIDS-defining illness are eligible; however, some antiviral/antiretroviral medications which have CYP3A4 interactions are prohibited on this study
18 Years
ALL
No
Sponsors
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SWOG Cancer Research Network
NETWORK
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Tufia C Haddad
Role: PRINCIPAL_INVESTIGATOR
Alliance for Clinical Trials in Oncology
Locations
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Providence Hospital
Mobile, Alabama, United States
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California, United States
Mills-Peninsula Medical Center
Burlingame, California, United States
East Bay Radiation Oncology Center
Castro Valley, California, United States
Eden Hospital Medical Center
Castro Valley, California, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States
Bay Area Breast Surgeons Inc
Emeryville, California, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States
Glendale Memorial Hospital and Health Center
Glendale, California, United States
Contra Costa Regional Medical Center
Martinez, California, United States
El Camino Hospital
Mountain View, California, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States
Sutter Cancer Research Consortium
Novato, California, United States
Highland General Hospital
Oakland, California, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States
Bay Area Tumor Institute
Oakland, California, United States
Hematology and Oncology Associates-Oakland
Oakland, California, United States
Tom K Lee Inc
Oakland, California, United States
Desert Regional Medical Center
Palm Springs, California, United States
Palo Alto Medical Foundation Health Care
Palo Alto, California, United States
Valley Care Health System - Pleasanton
Pleasanton, California, United States
Valley Medical Oncology Consultants
Pleasanton, California, United States
Salinas Valley Memorial
Salinas, California, United States
California Pacific Medical Center-Pacific Campus
San Francisco, California, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, United States
Sutter Solano Medical Center/Cancer Center
Vallejo, California, United States
The Medical Center of Aurora
Aurora, Colorado, United States
Boulder Community Hospital
Boulder, Colorado, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado, United States
Kaiser Permanente-Franklin
Denver, Colorado, United States
Porter Adventist Hospital
Denver, Colorado, United States
Presbyterian - Saint Lukes Medical Center - Health One
Denver, Colorado, United States
SCL Health Saint Joseph Hospital
Denver, Colorado, United States
Rose Medical Center
Denver, Colorado, United States
Western States Cancer Research NCORP
Denver, Colorado, United States
Swedish Medical Center
Englewood, Colorado, United States
Poudre Valley Hospital
Fort Collins, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
North Colorado Medical Center
Greeley, Colorado, United States
Kaiser Permanente-Rock Creek
Lafayette, Colorado, United States
Saint Anthony Hospital
Lakewood, Colorado, United States
Sky Ridge Medical Center
Lone Tree, Colorado, United States
Longmont United Hospital
Longmont, Colorado, United States
McKee Medical Center
Loveland, Colorado, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado, United States
North Suburban Medical Center
Thornton, Colorado, United States
SCL Health Lutheran Medical Center
Wheat Ridge, Colorado, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford, Connecticut, United States
Middlesex Hospital
Middletown, Connecticut, United States
The Hospital of Central Connecticut
New Britain, Connecticut, United States
Lynn Regional Cancer Center - West
Boca Raton, Florida, United States
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Jupiter Medical Center
Jupiter, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Sacred Heart Hospital
Pensacola, Florida, United States
John B Amos Cancer Center
Columbus, Georgia, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
South Georgia Medical Center/Pearlman Cancer Center
Valdosta, Georgia, United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho, United States
Saint Joseph Regional Medical Center
Lewiston, Idaho, United States
Saint Anthony's Health
Alton, Illinois, United States
Rush - Copley Medical Center
Aurora, Illinois, United States
Advocate Illinois Masonic Medical Center
Chicago, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Memorial Medical Center
Springfield, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, United States
Elkhart Clinic
Elkhart, Indiana, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart, Indiana, United States
Elkhart General Hospital
Elkhart, Indiana, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States
Community Howard Regional Health
Kokomo, Indiana, United States
IU Health La Porte Hospital
La Porte, Indiana, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth, Indiana, United States
Reid Health
Richmond, Indiana, United States
Memorial Hospital of South Bend
South Bend, Indiana, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States
South Bend Clinic
South Bend, Indiana, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States
Michiana Hematology Oncology PC-Westville
Westville, Indiana, United States
McFarland Clinic PC - Ames
Ames, Iowa, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, United States
Mercy Hospital
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States
Genesis Medical Center - East Campus
Davenport, Iowa, United States
Genesis Cancer Care Institute
Davenport, Iowa, United States
Mercy Capitol
Des Moines, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States
Iowa Lutheran Hospital
Des Moines, Iowa, United States
Finley Hospital
Dubuque, Iowa, United States
Mercy Medical Center - North Iowa
Mason City, Iowa, United States
Ottumwa Regional Health Center
Ottumwa, Iowa, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence
Independence, Kansas, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, United States
Lawrence Memorial Hospital
Lawrence, Kansas, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, United States
Cancer Center of Kansas - McPherson
McPherson, Kansas, United States
Cancer Center of Kansas - Newton
Newton, Kansas, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States
Cancer Center of Kansas - Salina
Salina, Kansas, United States
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States
Associates In Womens Health
Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States
Wichita NCI Community Oncology Research Program
Wichita, Kansas, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States
Tulane University Health Sciences Center
New Orleans, Louisiana, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
Suburban Hospital
Bethesda, Maryland, United States
Cancer Trials Support Unit
Rockville, Maryland, United States
Holy Cross Hospital
Silver Spring, Maryland, United States
Bixby Medical Center
Adrian, Michigan, United States
Hickman Cancer Center
Adrian, Michigan, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States
Bronson Battle Creek
Battle Creek, Michigan, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States
Beaumont Hospital - Dearborn
Dearborn, Michigan, United States
Ascension Saint John Hospital
Detroit, Michigan, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States
Genesys Hurley Cancer Institute
Flint, Michigan, United States
Hurley Medical Center
Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus
Flint, Michigan, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States
Allegiance Health
Jackson, Michigan, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, United States
West Michigan Cancer Center
Kalamazoo, Michigan, United States
Borgess Medical Center
Kalamazoo, Michigan, United States
Sparrow Hospital
Lansing, Michigan, United States
Saint Mary Mercy Hospital
Livonia, Michigan, United States
UP Health System Marquette
Marquette, Michigan, United States
Mercy Memorial Hospital
Monroe, Michigan, United States
Toledo Clinic Cancer Centers-Monroe
Monroe, Michigan, United States
McLaren Cancer Institute-Macomb
Mount Clemens, Michigan, United States
Mercy Health Partners-Hackley Campus
Muskegon, Michigan, United States
Mercy Health Mercy Campus
Muskegon, Michigan, United States
Lakeland Hospital Niles
Niles, Michigan, United States
Saint Joseph Mercy Oakland
Pontiac, Michigan, United States
Lake Huron Medical Center
Port Huron, Michigan, United States
Ascension Saint Mary's Hospital
Saginaw, Michigan, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States
Munson Medical Center
Traverse City, Michigan, United States
Saint John Macomb-Oakland Hospital
Warren, Michigan, United States
Metro Health Hospital
Wyoming, Michigan, United States
Medini, Eitan MD (UIA Investigator)
Alexandria, Minnesota, United States
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States
Fairview Ridges Hospital
Burnsville, Minnesota, United States
Mercy Hospital
Coon Rapids, Minnesota, United States
Fairview-Southdale Hospital
Edina, Minnesota, United States
Etzell, Paul S MD (UIA Investigator)
Fergus Falls, Minnesota, United States
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls, Minnesota, United States
Swenson, Wade II, MD (UIA Investigator)
Fergus Falls, Minnesota, United States
Unity Hospital
Fridley, Minnesota, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, United States
Meeker County Memorial Hospital
Litchfield, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States
Hennepin County Medical Center
Minneapolis, Minnesota, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud, Minnesota, United States
Saint Cloud Hospital
Saint Cloud, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States
Regions Hospital
Saint Paul, Minnesota, United States
United Hospital
Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States
Lakeview Hospital
Stillwater, Minnesota, United States
Ridgeview Medical Center
Waconia, Minnesota, United States
Rice Memorial Hospital
Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, United States
Singing River Hospital
Pascagoula, Mississippi, United States
Central Care Cancer Center - Bolivar
Bolivar, Missouri, United States
Cox Cancer Center Branson
Branson, Missouri, United States
Southeast Missouri Hospital
Cape Girardeau, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
Delbert Day Cancer Institute at PCRMC
Rolla, Missouri, United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, United States
Billings Clinic Cancer Center
Billings, Montana, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, United States
Saint Vincent Healthcare
Billings, Montana, United States
Montana Cancer Consortium NCORP
Billings, Montana, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, United States
Bozeman Deaconess Hospital
Bozeman, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, United States
Great Falls Clinic
Great Falls, Montana, United States
Northern Montana Hospital
Havre, Montana, United States
Saint Peter's Community Hospital
Helena, Montana, United States
Glacier Oncology PLLC
Kalispell, Montana, United States
Kalispell Medical Oncology
Kalispell, Montana, United States
Kalispell Regional Medical Center
Kalispell, Montana, United States
Montana Cancer Specialists
Missoula, Montana, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States
Community Medical Hospital
Missoula, Montana, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Nevada Cancer Research Foundation CCOP
Las Vegas, Nevada, United States
Virtua Memorial
Mount Holly, New Jersey, United States
Virtua Voorhees
Voorhees Township, New Jersey, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, United States
Glens Falls Hospital
Glens Falls, New York, United States
Orange Regional Medical Center
Middletown, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States
Montefiore Medical Center-Wakefield Campus
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States
Vidant Oncology-Kinston
Kinston, North Carolina, United States
Iredell Memorial Hospital
Statesville, North Carolina, United States
Mid Dakota Clinic
Bismarck, North Dakota, United States
Saint Alexius Medical Center
Bismarck, North Dakota, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States
Sanford Broadway Medical Center
Fargo, North Dakota, United States
Altru Cancer Center
Grand Forks, North Dakota, United States
Trinity Cancer Care Center
Minot, North Dakota, United States
Cleveland Clinic Akron General
Akron, Ohio, United States
Mary Rutan Hospital
Bellefontaine, Ohio, United States
Toledo Clinic Cancer Centers-Bowling Green
Bowling Green, Ohio, United States
Adena Regional Medical Center
Chillicothe, Ohio, United States
North Coast Cancer Care-Clyde
Clyde, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Columbus NCI Community Oncology Research Program
Columbus, Ohio, United States
Grant Medical Center
Columbus, Ohio, United States
Mount Carmel Health Center West
Columbus, Ohio, United States
Doctors Hospital
Columbus, Ohio, United States
Grandview Hospital
Dayton, Ohio, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Miami Valley Hospital North
Dayton, Ohio, United States
Dayton NCI Community Oncology Research Program
Dayton, Ohio, United States
Grady Memorial Hospital
Delaware, Ohio, United States
Hematology Oncology Center Incorporated
Elyria, Ohio, United States
Mercy Cancer Center-Elyria
Elyria, Ohio, United States
Blanchard Valley Hospital
Findlay, Ohio, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, United States
Wayne Hospital
Greenville, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Fairfield Medical Center
Lancaster, Ohio, United States
Saint Rita's Medical Center
Lima, Ohio, United States
Lima Memorial Hospital
Lima, Ohio, United States
Marietta Memorial Hospital
Marietta, Ohio, United States
Saint Luke's Hospital
Maumee, Ohio, United States
Toledo Clinic Cancer Centers-Maumee
Maumee, Ohio, United States
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
Maumee, Ohio, United States
Knox Community Hospital
Mount Vernon, Ohio, United States
Licking Memorial Hospital
Newark, Ohio, United States
Fisher-Titus Medical Center
Norwalk, Ohio, United States
Saint Charles Hospital
Oregon, Ohio, United States
Toledo Clinic Cancer Centers-Oregon
Oregon, Ohio, United States
Southern Ohio Medical Center
Portsmouth, Ohio, United States
North Coast Cancer Care
Sandusky, Ohio, United States
Springfield Regional Medical Center
Springfield, Ohio, United States
ProMedica Flower Hospital
Sylvania, Ohio, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, United States
The Toledo Hospital/Toledo Children's Hospital
Toledo, Ohio, United States
Saint Vincent Mercy Medical Center
Toledo, Ohio, United States
University of Toledo
Toledo, Ohio, United States
Toledo Community Hospital Oncology Program CCOP
Toledo, Ohio, United States
Mercy Saint Anne Hospital
Toledo, Ohio, United States
Toledo Clinic Cancer Centers-Toledo
Toledo, Ohio, United States
Upper Valley Medical Center
Troy, Ohio, United States
Fulton County Health Center
Wauseon, Ohio, United States
Saint Ann's Hospital
Westerville, Ohio, United States
Clinton Memorial Hospital
Wilmington, Ohio, United States
Greene Memorial Hospital
Xenia, Ohio, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States
Providence Milwaukie Hospital
Milwaukie, Oregon, United States
Providence Newberg Medical Center
Newberg, Oregon, United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Adventist Medical Center
Portland, Oregon, United States
Providence Saint Vincent Medical Center
Portland, Oregon, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania, United States
Butler Memorial Hospital
Butler, Pennsylvania, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, United States
Geisinger Medical Group
State College, Pennsylvania, United States
Mount Nittany Medical Center
State College, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, United States
McLeod Regional Medical Center
Florence, South Carolina, United States
Avera Cancer Institute-Aberdeen
Aberdeen, South Dakota, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States
Sanford NCI Community Oncology Research Program of the North Central Plains
Sioux Falls, South Dakota, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States
Medical X-Ray Center
Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, United States
Thompson Cancer Survival Center
Knoxville, Tennessee, United States
University of Tennessee - Knoxville
Knoxville, Tennessee, United States
The Don and Sybil Harrington Cancer Center
Amarillo, Texas, United States
Medical City Dallas Hospital
Dallas, Texas, United States
Danville Regional Medical Center
Danville, Virginia, United States
Fredericksburg Oncology Inc
Fredericksburg, Virginia, United States
Sovah Health Martinsville
Martinsville, Virginia, United States
Southwest VA Regional Cancer Center
Norton, Virginia, United States
Cancer Care Center at Island Hospital
Anacortes, Washington, United States
Overlake Hospital Medical Center
Bellevue, Washington, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States
Highline Medical Center-Main Campus
Burien, Washington, United States
Providence Regional Cancer System-Centralia
Centralia, Washington, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Saint Francis Hospital
Federal Way, Washington, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States
Saint Clare Hospital
Lakewood, Washington, United States
Skagit Valley Hospital
Mount Vernon, Washington, United States
Providence - Saint Peter Hospital
Olympia, Washington, United States
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo, Washington, United States
MultiCare Good Samaritan Hospital
Puyallup, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Minor and James Medical PLLC
Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Kaiser Permanente Washington
Seattle, Washington, United States
Swedish Medical Center-First Hill
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, United States
Evergreen Hematology and Oncology PS
Spokane, Washington, United States
MultiCare Allenmore Hospital
Tacoma, Washington, United States
MultiCare Tacoma General Hospital
Tacoma, Washington, United States
Northwest NCI Community Oncology Research Program
Tacoma, Washington, United States
Saint Joseph Medical Center
Tacoma, Washington, United States
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States
Aurora Cancer Care-Southern Lakes VLCC
Burlington, Wisconsin, United States
Aurora Cancer Care-Franklin
Franklin, Wisconsin, United States
Aurora Health Care Germantown Health Center
Germantown, Wisconsin, United States
Aurora Cancer Care-Glendale
Glendale, Wisconsin, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, United States
Aurora Cancer Care-Kenosha South
Kenosha, Wisconsin, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States
Bay Area Medical Center
Marinette, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, United States
Aurora Cancer Care-Racine
Racine, Wisconsin, United States
HSHS Saint Nicholas Hospital
Sheboygan, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States
Aurora Cancer Care-Waukesha
Waukesha, Wisconsin, United States
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States
Rocky Mountain Oncology
Casper, Wyoming, United States
Welch Cancer Center
Sheridan, Wyoming, United States
Countries
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References
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Haddad TC, He J, O'Sullivan CC, Chen B, Northfelt D, Dueck AC, Ballman KV, Tenner KS, Linden H, Sparano JA, Hopkins JO, De Silva C, Perez EA, Haluska P, Goetz MP. Randomized Phase II Trial of Capecitabine and Lapatinib with or without IMC-A12 (Cituxumumab) in Patients with HER2-Positive Advanced Breast Cancer Previously Treated with Trastuzumab and Chemotherapy: NCCTG N0733 (Alliance). Breast Cancer Res Treat. 2021 Jul;188(2):477-487. doi: 10.1007/s10549-021-06221-8. Epub 2021 Apr 14.
Other Identifiers
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NCI-2009-00665
Identifier Type: REGISTRY
Identifier Source: secondary_id
PN0733_A15PAMDREVW01
Identifier Type: -
Identifier Source: secondary_id
NCCTG N0733
Identifier Type: -
Identifier Source: secondary_id
CDR0000596070
Identifier Type: -
Identifier Source: secondary_id
NCCTG-N0733
Identifier Type: -
Identifier Source: secondary_id
N0733
Identifier Type: OTHER
Identifier Source: secondary_id
N0733
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00665
Identifier Type: -
Identifier Source: org_study_id
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