Capecitabine and Lapatinib Ditosylate With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB-IV Breast Cancer

March 11, 2020 updated by: National Cancer Institute (NCI)

Randomized Phase II Trial of Capecitabine and Lapatinib With or Without IMC-A12 in Patients With HER2 Positive Breast Cancer Previously Treated With Trastuzumab and an Anthracycline and/or a Taxane

This phase II trial studies capecitabine and lapatinib ditosylate to see how well they work compared with capecitabine, lapatinib ditosylate, and cixutumumab in treating patients with previously treated HER2-positive stage IIIB-IV breast cancer. Drugs used in chemotherapy, such as capecitabine, 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. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with cixutumumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether capecitabine and lapatinib ditosylate are more effective when given with or without cixutumumab in treating breast cancer that has spread nearby or to other areas of the body.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

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.

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Mobile, Alabama, United States, 36608
    - Providence Hospital
- Arizona
  - Scottsdale, Arizona, United States, 85259
    - Mayo Clinic in Arizona
- California
  - Berkeley, California, United States, 94704
    - Alta Bates Summit Medical Center-Herrick Campus
  - Burlingame, California, United States, 94010
    - Mills-Peninsula Medical Center
  - Castro Valley, California, United States, 94546
    - Eden Hospital Medical Center
  - Castro Valley, California, United States, 94546
    - East Bay Radiation Oncology Center
  - Castro Valley, California, United States, 94546
    - Valley Medical Oncology Consultants-Castro Valley
  - Emeryville, California, United States, 94608
    - Bay Area Breast Surgeons Inc
  - Fremont, California, United States, 94538
    - Valley Medical Oncology Consultants-Fremont
  - Glendale, California, United States, 91204
    - Glendale Memorial Hospital and Health Center
  - Martinez, California, United States, 94553-3156
    - Contra Costa Regional Medical Center
  - Mountain View, California, United States, 94040
    - El Camino Hospital
  - Mountain View, California, United States, 94040
    - Palo Alto Medical Foundation-Camino Division
  - Novato, California, United States, 94945
    - Sutter Cancer Research Consortium
  - Oakland, California, United States, 94609
    - Alta Bates Summit Medical Center - Summit Campus
  - Oakland, California, United States, 94609
    - Hematology and Oncology Associates-Oakland
  - Oakland, California, United States, 94602
    - Highland General Hospital
  - Oakland, California, United States, 94609
    - Tom K Lee Inc
  - Oakland, California, United States, 94609
    - Bay Area Tumor Institute
  - Palm Springs, California, United States, 92262
    - Desert Regional Medical Center
  - Palo Alto, California, United States, 94301
    - Palo Alto Medical Foundation Health Care
  - Pleasanton, California, United States, 94588
    - Valley Care Health System - Pleasanton
  - Pleasanton, California, United States, 94588
    - Valley Medical Oncology Consultants
  - Salinas, California, United States, 93901
    - Salinas Valley Memorial
  - San Francisco, California, United States, 94115
    - California Pacific Medical Center-Pacific Campus
  - San Pablo, California, United States, 94806
    - Doctors Medical Center- JC Robinson Regional Cancer Center
  - Vallejo, California, United States, 94589
    - Sutter Solano Medical Center/Cancer Center
- Colorado
  - Aurora, Colorado, United States, 80012
    - The Medical Center of Aurora
  - Boulder, Colorado, United States, 80301
    - Boulder Community Hospital
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Denver, Colorado, United States, 80205
    - Kaiser Permanente-Franklin
  - Denver, Colorado, United States, 80218
    - Presbyterian - Saint Lukes Medical Center - Health One
  - Denver, Colorado, United States, 80218
    - SCL Health Saint Joseph Hospital
  - Denver, Colorado, United States, 80220
    - Rose Medical Center
  - Denver, Colorado, United States, 80222
    - Western States Cancer Research NCORP
  - Englewood, Colorado, United States, 80113
    - Swedish Medical Center
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Grand Junction, Colorado, United States, 81501
    - Saint Mary's Hospital and Regional Medical Center
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Lafayette, Colorado, United States, 80026
    - Kaiser Permanente-Rock Creek
  - Lakewood, Colorado, United States, 80228
    - Saint Anthony Hospital
  - Lone Tree, Colorado, United States, 80124
    - Sky Ridge Medical Center
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
  - Thornton, Colorado, United States, 80229
    - North Suburban Medical Center
  - Wheat Ridge, Colorado, United States, 80033
    - SCL Health Lutheran Medical Center
- Connecticut
  - Hartford, Connecticut, United States, 06105
    - Smilow Cancer Hospital Care Center at Saint Francis
  - Middletown, Connecticut, United States, 06457
    - Middlesex Hospital
  - New Britain, Connecticut, United States, 06050
    - The Hospital of Central Connecticut
- Florida
  - Boca Raton, Florida, United States, 33428
    - Lynn Regional Cancer Center - West
  - Fort Lauderdale, Florida, United States, 33308
    - Holy Cross Hospital
  - Hollywood, Florida, United States, 33021
    - Memorial Regional Hospital/Joe DiMaggio Children's Hospital
  - Jacksonville, Florida, United States, 32224-9980
    - Mayo Clinic in Florida
  - Jupiter, Florida, United States, 33458
    - Jupiter Medical Center
  - Miami Beach, Florida, United States, 33140
    - Mount Sinai Medical Center
  - Orlando, Florida, United States, 32803
    - AdventHealth Orlando
  - Pensacola, Florida, United States, 32504
    - Sacred Heart Hospital
- Georgia
  - Columbus, Georgia, United States, 31904
    - John B Amos Cancer Center
  - Savannah, Georgia, United States, 31404
    - Memorial Health University Medical Center
  - Valdosta, Georgia, United States, 31602
    - South Georgia Medical Center/Pearlman Cancer Center
- Idaho
  - Boise, Idaho, United States, 83706
    - Saint Alphonsus Cancer Care Center-Boise
  - Lewiston, Idaho, United States, 83501
    - Saint Joseph Regional Medical Center
- Illinois
  - Alton, Illinois, United States, 62002
    - Saint Anthony's Health
  - Aurora, Illinois, United States, 60504
    - Rush - Copley Medical Center
  - Chicago, Illinois, United States, 60657
    - Advocate Illinois Masonic Medical Center
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology-Hematology Associates Limited
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - Springfield, Illinois, United States, 62781
    - Memorial Medical Center
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
- Indiana
  - Beech Grove, Indiana, United States, 46107
    - Franciscan Saint Francis Health-Beech Grove
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - Elkhart, Indiana, United States, 46514
    - Michiana Hematology Oncology PC-Elkhart
  - Elkhart, Indiana, United States, 46514-2098
    - Elkhart Clinic
  - Fort Wayne, Indiana, United States, 46845
    - Fort Wayne Medical Oncology and Hematology Inc-Parkview
  - Kokomo, Indiana, United States, 46904
    - Community Howard Regional Health
  - La Porte, Indiana, United States, 46350
    - IU Health La Porte Hospital
  - Michigan City, Indiana, United States, 46360
    - Franciscan Saint Anthony Health-Michigan City
  - Mishawaka, Indiana, United States, 46545
    - Michiana Hematology Oncology PC-Mishawaka
  - Mishawaka, Indiana, United States, 46545
    - Saint Joseph Regional Medical Center-Mishawaka
  - Plymouth, Indiana, United States, 46563
    - Michiana Hematology Oncology PC-Plymouth
  - Richmond, Indiana, United States, 47374
    - Reid Health
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - Michiana Hematology Oncology PC-South Bend
  - South Bend, Indiana, United States, 46628
    - Northern Indiana Cancer Research Consortium
  - South Bend, Indiana, United States, 46617
    - South Bend Clinic
  - Westville, Indiana, United States, 46391
    - Michiana Hematology Oncology PC-Westville
- Iowa
  - Ames, Iowa, United States, 50010
    - McFarland Clinic PC - Ames
  - Bettendorf, Iowa, United States, 52722
    - University of Iowa Healthcare Cancer Services Quad Cities
  - Cedar Rapids, Iowa, United States, 52403
    - Mercy Hospital
  - Cedar Rapids, Iowa, United States, 52403
    - Oncology Associates at Mercy Medical Center
  - Clive, Iowa, United States, 50325
    - Medical Oncology and Hematology Associates-West Des Moines
  - Davenport, Iowa, United States, 52803
    - Genesis Medical Center - East Campus
  - Davenport, Iowa, United States, 52804
    - Genesis Cancer Care Institute
  - Des Moines, Iowa, United States, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates-Des Moines
  - Des Moines, Iowa, United States, 50316
    - Iowa Lutheran Hospital
  - Des Moines, Iowa, United States, 50309
    - Iowa-Wide Oncology Research Coalition NCORP
  - Des Moines, Iowa, United States, 50314
    - Medical Oncology and Hematology Associates-Laurel
  - Des Moines, Iowa, United States, 50307
    - Mercy Capitol
  - Dubuque, Iowa, United States, 52001
    - Finley Hospital
  - Mason City, Iowa, United States, 50401
    - Mercy Medical Center - North Iowa
  - Ottumwa, Iowa, United States, 52501
    - Ottumwa Regional Health Center
  - Sioux City, Iowa, United States, 51101
    - Siouxland Regional Cancer Center
  - Sioux City, Iowa, United States, 51102
    - Mercy Medical Center-Sioux City
  - Sioux City, Iowa, United States, 51104
    - Saint Luke's Regional Medical Center
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas - El Dorado
  - Fort Scott, Kansas, United States, 66701
    - Cancer Center of Kansas - Fort Scott
  - Independence, Kansas, United States, 67301
    - Cancer Center of Kansas-Independence
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas-Kingman
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Liberal, Kansas, United States, 67905
    - Cancer Center of Kansas-Liberal
  - McPherson, Kansas, United States, 67460
    - Cancer Center of Kansas - McPherson
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas - Newton
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas - Parsons
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas - Pratt
  - Salina, Kansas, United States, 67401
    - Cancer Center of Kansas - Salina
  - Topeka, Kansas, United States, 66606
    - Cotton O'Neil Cancer Center / Stormont Vail Health
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas - Wellington
  - Wichita, Kansas, United States, 67214
    - Ascension Via Christi Hospitals Wichita
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas - Wichita
  - Wichita, Kansas, United States, 67208
    - Associates In Womens Health
  - Wichita, Kansas, United States, 67214
    - Wichita NCI Community Oncology Research Program
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas - Winfield
- Louisiana
  - New Orleans, Louisiana, United States, 70112
    - Tulane University Health Sciences Center
- Maryland
  - Baltimore, Maryland, United States, 21201
    - University of Maryland/Greenebaum Cancer Center
  - Bethesda, Maryland, United States, 20814
    - Suburban Hospital
  - Rockville, Maryland, United States, 20850-2062
    - Cancer Trials Support Unit
  - Silver Spring, Maryland, United States, 20910
    - Holy Cross Hospital
- Michigan
  - Adrian, Michigan, United States, 49221
    - Bixby Medical Center
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center
  - Ann Arbor, Michigan, United States, 48106
    - Saint Joseph Mercy Hospital
  - Ann Arbor, Michigan, United States, 48106
    - Michigan Cancer Research Consortium NCORP
  - Battle Creek, Michigan, United States, 49017
    - Bronson Battle Creek
  - Big Rapids, Michigan, United States, 49307
    - Spectrum Health Big Rapids Hospital
  - Dearborn, Michigan, United States, 48124
    - Beaumont Hospital - Dearborn
  - Detroit, Michigan, United States, 48236
    - Ascension Saint John Hospital
  - Escanaba, Michigan, United States, 49829
    - Green Bay Oncology - Escanaba
  - Flint, Michigan, United States, 48532
    - Genesys Regional Medical Center-West Flint Campus
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grand Rapids, Michigan, United States, 49503
    - Spectrum Health at Butterworth Campus
  - Grand Rapids, Michigan, United States, 49503
    - Mercy Health Saint Mary's
  - Grand Rapids, Michigan, United States, 49503
    - Cancer Research Consortium of West Michigan NCORP
  - Iron Mountain, Michigan, United States, 49801
    - Green Bay Oncology - Iron Mountain
  - Jackson, Michigan, United States, 49201
    - Allegiance Health
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49048
    - Borgess Medical Center
  - Lansing, Michigan, United States, 48912
    - Sparrow Hospital
  - Livonia, Michigan, United States, 48154
    - Saint Mary Mercy Hospital
  - Marquette, Michigan, United States, 49855
    - UP Health System Marquette
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital
  - Monroe, Michigan, United States, 48162
    - Toledo Clinic Cancer Centers-Monroe
  - Mount Clemens, Michigan, United States, 48043
    - McLaren Cancer Institute-Macomb
  - Muskegon, Michigan, United States, 49444
    - Mercy Health Mercy Campus
  - Muskegon, Michigan, United States, 49442
    - Mercy Health Partners-Hackley Campus
  - Niles, Michigan, United States, 49120
    - Lakeland Hospital Niles
  - Pontiac, Michigan, United States, 48341
    - Saint Joseph Mercy Oakland
  - Port Huron, Michigan, United States, 48060
    - Lake Huron Medical Center
  - Saginaw, Michigan, United States, 48601
    - Ascension Saint Mary's Hospital
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Medical Center Saint Joseph
  - Saint Joseph, Michigan, United States, 49085
    - Marie Yeager Cancer Center
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
  - Wyoming, Michigan, United States, 49519
    - Metro Health Hospital
- Minnesota
  - Alexandria, Minnesota, United States, 56308
    - Medini, Eitan MD (UIA Investigator)
  - Bemidji, Minnesota, United States, 56601
    - Sanford Joe Lueken Cancer Center
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview-Southdale Hospital
  - Fergus Falls, Minnesota, United States, 56537
    - Lake Region Healthcare Corporation-Cancer Care
  - Fergus Falls, Minnesota, United States, 56537
    - Etzell, Paul S MD (UIA Investigator)
  - Fergus Falls, Minnesota, United States, 56537
    - Swenson, Wade II, MD (UIA Investigator)
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - Litchfield, Minnesota, United States, 55355
    - Meeker County Memorial Hospital
  - Maplewood, Minnesota, United States, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55407
    - Virginia Piper Cancer Institute
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic
  - Saint Cloud, Minnesota, United States, 56303
    - Coborn Cancer Center at Saint Cloud Hospital
  - Saint Cloud, Minnesota, United States, 56303
    - Saint Cloud Hospital
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Louis Park, Minnesota, United States, 55416
    - Metro Minnesota Community Oncology Research Consortium
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology PA-Woodbury
- Mississippi
  - Pascagoula, Mississippi, United States, 39581
    - Singing River Hospital
- Missouri
  - Bolivar, Missouri, United States, 65613
    - Central Care Cancer Center - Bolivar
  - Branson, Missouri, United States, 65616
    - Cox Cancer Center Branson
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63701
    - Southeast Missouri Hospital
  - Rolla, Missouri, United States, 65401
    - Delbert Day Cancer Institute at PCRMC
  - Saint Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
  - Saint Louis, Missouri, United States, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - Saint Louis, Missouri, United States, 63141
    - Saint Louis-Cape Girardeau CCOP
  - Springfield, Missouri, United States, 65804
    - Cancer Research for the Ozarks NCORP
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
- Montana
  - Billings, Montana, United States, 59101
    - Billings Clinic Cancer Center
  - Billings, Montana, United States, 59101
    - Saint Vincent Healthcare
  - Billings, Montana, United States, 59102
    - Montana Cancer Consortium NCORP
  - Billings, Montana, United States, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, United States, 59102
    - Saint Vincent Frontier Cancer Center
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Butte, Montana, United States, 59701
    - Saint James Community Hospital and Cancer Treatment Center
  - 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
    - Berdeaux, Donald MD (UIA Investigator)
  - Havre, Montana, United States, 59501
    - Northern Montana Hospital
  - Helena, Montana, United States, 59601
    - Saint Peter's Community Hospital
  - Kalispell, Montana, United States, 59901
    - Kalispell Regional Medical Center
  - Kalispell, Montana, United States, 59901
    - Glacier Oncology PLLC
  - Kalispell, Montana, United States, 59901
    - Kalispell Medical Oncology
  - Missoula, Montana, United States, 59804
    - Community Medical Hospital
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
  - Missoula, Montana, United States, 59804
    - Guardian Oncology and Center for Wellness
  - Missoula, Montana, United States, 59802
    - Montana Cancer Specialists
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - Nevada Cancer Research Foundation CCOP
- New Jersey
  - Mount Holly, New Jersey, United States, 08060
    - Virtua Memorial
  - Voorhees, New Jersey, United States, 08043
    - Virtua Voorhees
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - University of New Mexico Cancer Center
- New York
  - Bronx, New York, United States, 10467
    - Montefiore Medical Center - Moses Campus
  - Bronx, New York, United States, 10461
    - Montefiore Medical Center-Weiler Hospital
  - Bronx, New York, United States, 10466
    - Montefiore Medical Center-Wakefield Campus
  - East Syracuse, New York, United States, 13057
    - Hematology Oncology Associates of Central New York-East Syracuse
  - Glens Falls, New York, United States, 12801
    - Glens Falls Hospital
  - Middletown, New York, United States, 10940
    - Orange Regional Medical Center
  - Staten Island, New York, United States, 10305
    - Staten Island University Hospital
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Novant Health Presbyterian Medical Center
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital
  - Hendersonville, North Carolina, United States, 28791
    - Margaret R Pardee Memorial Hospital
  - Kinston, North Carolina, United States, 28501
    - Vidant Oncology-Kinston
  - Statesville, North Carolina, United States, 28677
    - Iredell Memorial Hospital
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Sanford Bismarck Medical Center
  - Bismarck, North Dakota, United States, 58501
    - Mid Dakota Clinic
  - Bismarck, North Dakota, United States, 58501
    - Saint Alexius Medical Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Broadway Medical Center
  - Grand Forks, North Dakota, United States, 58201
    - Altru Cancer Center
  - Minot, North Dakota, United States, 58701
    - Trinity Cancer Care Center
- Ohio
  - Akron, Ohio, United States, 44307
    - Cleveland Clinic Akron General
  - Bellefontaine, Ohio, United States, 43311
    - Mary Rutan Hospital
  - Bowling Green, Ohio, United States, 43402
    - Toledo Clinic Cancer Centers-Bowling Green
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Clyde, Ohio, United States, 43410
    - North Coast Cancer Care-Clyde
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health Center West
  - Columbus, Ohio, United States, 43215
    - Columbus NCI Community Oncology Research Program
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital - Dayton
  - Dayton, Ohio, United States, 45409
    - Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Miami Valley Hospital North
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45459
    - Dayton NCI Community Oncology Research Program
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Elyria, Ohio, United States, 44035
    - Mercy Cancer Center-Elyria
  - Elyria, Ohio, United States, 44035
    - Hematology Oncology Center Incorporated
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Hospital
  - Franklin, Ohio, United States, 45005-1066
    - Atrium Medical Center-Middletown Regional Hospital
  - Greenville, Ohio, United States, 45331
    - Wayne Hospital
  - Kettering, Ohio, United States, 45429
    - Kettering Medical Center
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lima, Ohio, United States, 45801
    - Saint Rita's Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Marietta, Ohio, United States, 45750
    - Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537
    - Toledo Clinic Cancer Centers-Maumee
  - Maumee, Ohio, United States, 43537
    - Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
  - Maumee, Ohio, United States, 43537
    - Saint Luke's Hospital
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Hospital
  - Norwalk, Ohio, United States, 44857
    - Fisher-Titus Medical Center
  - Oregon, Ohio, United States, 43616
    - Saint Charles Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic Cancer Centers-Oregon
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care
  - Springfield, Ohio, United States, 45505
    - Springfield Regional Medical Center
  - Sylvania, Ohio, United States, 43560
    - ProMedica Flower Hospital
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - Saint Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic Cancer Centers-Toledo
  - Toledo, Ohio, United States, 43614
    - University of Toledo
  - Toledo, Ohio, United States, 43617
    - Toledo Community Hospital Oncology Program CCOP
  - Toledo, Ohio, United States, 43606
    - The Toledo Hospital/Toledo Children's Hospital
  - Toledo, Ohio, United States, 43623
    - Mercy Saint Anne Hospital
  - Troy, Ohio, United States, 45373
    - Upper Valley Medical Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
  - Wilmington, Ohio, United States, 45177
    - Clinton Memorial Hospital
  - Xenia, Ohio, United States, 45385
    - Greene Memorial Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis Healthcare System Cancer Care Center
- Oregon
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Oregon City, Oregon, United States, 97045
    - Providence Willamette Falls Medical Center
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
  - Portland, Oregon, United States, 97216
    - Adventist Medical Center
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Abington Memorial Hospital
  - Allentown, Pennsylvania, United States, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Butler, Pennsylvania, United States, 16001
    - Butler Memorial Hospital
  - Danville, Pennsylvania, United States, 17822
    - Geisinger Medical Center
  - Hazleton, Pennsylvania, United States, 18201
    - Geisinger Medical Center-Cancer Center Hazleton
  - State College, Pennsylvania, United States, 16801
    - Geisinger Medical Group
  - State College, Pennsylvania, United States, 16803
    - Mount Nittany Medical Center
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Geisinger Wyoming Valley/Henry Cancer Center
- South Carolina
  - Florence, South Carolina, United States, 29506
    - McLeod Regional Medical Center
- South Dakota
  - Aberdeen, South Dakota, United States, 57401
    - Avera Cancer Institute-Aberdeen
  - Sioux Falls, South Dakota, United States, 57105
    - Avera Cancer Institute
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Cancer Center Oncology Clinic
  - Sioux Falls, South Dakota, United States, 57105
    - Medical X-Ray Center
  - Sioux Falls, South Dakota, United States, 57105
    - Avera McKennan Hospital and University Health Center
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford NCI Community Oncology Research Program of the North Central Plains
- Tennessee
  - Kingsport, Tennessee, United States, 37660
    - Wellmont Holston Valley Hospital and Medical Center
  - Knoxville, Tennessee, United States, 37916
    - Thompson Cancer Survival Center
  - Knoxville, Tennessee, United States, 37920
    - University of Tennessee - Knoxville
- Texas
  - Amarillo, Texas, United States, 79106
    - The Don and Sybil Harrington Cancer Center
  - Dallas, Texas, United States, 75230
    - Medical City Dallas Hospital
- Virginia
  - Danville, Virginia, United States, 24541
    - Danville Regional Medical Center
  - Fredericksburg, Virginia, United States, 22401
    - Fredericksburg Oncology Inc
  - Martinsville, Virginia, United States, 24115
    - Sovah Health Martinsville
  - Norton, Virginia, United States, 24273
    - Southwest VA Regional Cancer Center
- Washington
  - Anacortes, Washington, United States, 98221
    - Cancer Care Center at Island Hospital
  - Bellevue, Washington, United States, 98004
    - Overlake Hospital Medical Center
  - Bellingham, Washington, United States, 98225
    - PeaceHealth Saint Joseph Medical Center
  - Bremerton, Washington, United States, 98310
    - Harrison HealthPartners Hematology and Oncology-Bremerton
  - Burien, Washington, United States, 98166
    - Highline Medical Center-Main Campus
  - Centralia, Washington, United States, 98531
    - Providence Regional Cancer System-Centralia
  - Everett, Washington, United States, 98201
    - Providence Regional Cancer Partnership
  - Federal Way, Washington, United States, 98003
    - Saint Francis Hospital
  - Kennewick, Washington, United States, 99336
    - Kadlec Clinic Hematology and Oncology
  - Lakewood, Washington, United States, 98499
    - Saint Clare Hospital
  - Mount Vernon, Washington, United States, 98274
    - Skagit Valley Hospital
  - Olympia, Washington, United States, 98506-5166
    - Providence - Saint Peter Hospital
  - Poulsbo, Washington, United States, 98370
    - Harrison HealthPartners Hematology and Oncology-Poulsbo
  - Puyallup, Washington, United States, 98372
    - MultiCare Good Samaritan Hospital
  - Seattle, Washington, United States, 98109
    - Fred Hutchinson Cancer Research Center
  - Seattle, Washington, United States, 98195
    - University of Washington Medical Center
  - Seattle, Washington, United States, 98104
    - Harborview Medical Center
  - Seattle, Washington, United States, 98112
    - Kaiser Permanente Washington
  - Seattle, Washington, United States, 98104
    - Minor and James Medical PLLC
  - Seattle, Washington, United States, 98122-4307
    - Swedish Medical Center-First Hill
  - Sedro-Woolley, Washington, United States, 98284
    - PeaceHealth United General Medical Center
  - Spokane, Washington, United States, 99218
    - Evergreen Hematology and Oncology PS
  - Spokane, Washington, United States, 99202
    - Cancer Care Northwest - Spokane South
  - Tacoma, Washington, United States, 98405
    - MultiCare Tacoma General Hospital
  - Tacoma, Washington, United States, 98405
    - MultiCare Allenmore Hospital
  - Tacoma, Washington, United States, 98405
    - Northwest NCI Community Oncology Research Program
  - Tacoma, Washington, United States, 98405
    - Saint Joseph Medical Center
  - Vancouver, Washington, United States, 98664
    - PeaceHealth Southwest Medical Center
  - Wenatchee, Washington, United States, 98801
    - Wenatchee Valley Hospital and Clinics
- West Virginia
  - Huntington, West Virginia, United States, 25701
    - Edwards Comprehensive Cancer Center
- Wisconsin
  - Burlington, Wisconsin, United States, 53105
    - Aurora Cancer Care-Southern Lakes VLCC
  - Franklin, Wisconsin, United States, 53132
    - Aurora Cancer Care-Franklin
  - Germantown, Wisconsin, United States, 53022
    - Aurora Health Care Germantown Health Center
  - Glendale, Wisconsin, United States, 53212
    - Aurora Cancer Care-Glendale
  - Green Bay, Wisconsin, United States, 54301
    - Saint Vincent Hospital Cancer Center Green Bay
  - Green Bay, Wisconsin, United States, 54303
    - Saint Vincent Hospital Cancer Center at Saint Mary's
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology Limited at Saint Mary's Hospital
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology at Saint Vincent Hospital
  - Kenosha, Wisconsin, United States, 53142
    - Aurora Cancer Care-Kenosha South
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Center
  - Manitowoc, Wisconsin, United States, 54221
    - Holy Family Memorial Hospital
  - Marinette, Wisconsin, United States, 54143
    - Bay Area Medical Center
  - Milwaukee, Wisconsin, United States, 53215
    - Aurora Saint Luke's Medical Center
  - Oconto Falls, Wisconsin, United States, 54154
    - Saint Vincent Hospital Cancer Center at Oconto Falls
  - Racine, Wisconsin, United States, 53406
    - Aurora Cancer Care-Racine
  - Sheboygan, Wisconsin, United States, 53081
    - HSHS Saint Nicholas Hospital
  - Sturgeon Bay, Wisconsin, United States, 54235-1495
    - Saint Vincent Hospital Cancer Center at Sturgeon Bay
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology - Sturgeon Bay
  - Waukesha, Wisconsin, United States, 53188
    - Aurora Cancer Care-Waukesha
  - Wauwatosa, Wisconsin, United States, 53226
    - Aurora Cancer Care-Milwaukee West
- Wyoming
  - Casper, Wyoming, United States, 82609
    - Rocky Mountain Oncology
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Histologically confirmed, locally advanced: (a T4 primary tumor and stage IIIB or IIIC disease) or metastatic breast cancer that has progressed after treatment with regimens that included trastuzumab and either an anthracycline or a taxane or both
- 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:

Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
- 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Drug: Capecitabine Given PO Other Names: Xeloda Ro 09-1978/000 Drug: Lapatinib Ditosylate Given PO Other Names: Tykerb
Experimental: 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.	Other: Quality-of-Life Assessment Ancillary studies Other Names: Quality of Life Assessment Drug: Capecitabine Given PO Other Names: Xeloda Ro 09-1978/000 Biological: Cixutumumab Given IV Other Names: IMC-A12 Anti-IGF-1R Recombinant Monoclonal Antibody IMC-A12 Drug: Lapatinib Ditosylate Given PO Other Names: Tykerb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS) Time Frame: From randomization to the earliest date of documentation of disease progression, up to 5 years	Analysis of the primary endpoint, PFS, will be performed using Cox regression with treatment group as a single covariate.	From randomization to the earliest date of documentation of disease progression, up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Time Frame: From randomization to death due to any cause, up to 5 years	Median Survival time (months)	From randomization to death due to any cause, up to 5 years
Time to Treatment Failure Time Frame: From the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal, up to 5 years	Distribution estimated by the Kaplan-Meier (1958) method for each treatment arm.	From the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal, up to 5 years
Confirmed Tumor Response, Defined as Either a Complete Response (CR) or Partial Response (PR) Noted as the Objective Status on 2 Consecutive Evaluations at Least 6 Weeks Apart, Assessed by Response Evaluation Criteria for Solid Tumors (RECIST) Time Frame: Up to 5 years		Up to 5 years
Duration of Response Time Frame: Up to 5 years	Distribution estimated by the Kaplan-Meier (1958) method for each treatment arm.	Up to 5 years
Adverse Event Profile of Capecitabine and Lapatinib With and Without IMC-A12 (Using NCI CTCAE v3.0) Time Frame: Baseline to 30 days past end of treatment	All eligible patients that have initiated treatment will be considered evaluable for assessing adverse event rate(s) according to CTCAE v3.0 within each treatment arm. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. 4/19 (21.05%) 14/45 (31.11%)	Baseline to 30 days past end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Collaborators

Southwest Oncology Group

Investigators

Principal Investigator: Tufia C Haddad, Alliance for Clinical Trials in Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 30, 2008

Primary Completion (Actual)

January 7, 2014

Study Completion (Actual)

October 15, 2019

Study Registration Dates

First Submitted

May 22, 2008

First Submitted That Met QC Criteria

May 24, 2008

First Posted (Estimate)

May 28, 2008

Study Record Updates

Last Update Posted (Actual)

March 24, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

NCI-2009-00665 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
U10CA180821 (U.S. NIH Grant/Contract)
U10CA025224 (U.S. NIH Grant/Contract)
PN0733_A15PAMDREVW01
NCCTG N0733
CDR0000596070
NCCTG-N0733
N0733 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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National Cancer Institute (NCI)

Recruiting

Well-Being and Health-Related Quality of Life in Cancer Patients and Survivors During the COVID-19 Pandemic

Hematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 Infection

United States
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Active, not recruiting

Well-being in Cancer Patients With Neuropathy During COVID-19 Who Participated in Prior Clinical Trials

Hematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | Neuropathy | COVID-19 Infection

United States
M.D. Anderson Cancer Center

Active, not recruiting

Longitudinal Evaluation of Women Undergoing Pelvic Surgery for the Treatment of Gynecologic Cancer

Cervical Carcinoma | Endometrial Carcinoma | Vaginal Carcinoma | Malignant Female Reproductive System Neoplasm | Vulvar Carcinoma

United States
Academic and Community Cancer Research United
National Cancer Institute (NCI)

Active, not recruiting

Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations

Metastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 and other conditions

United States

Capecitabine and Lapatinib Ditosylate With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB-IV Breast Cancer

Randomized Phase II Trial of Capecitabine and Lapatinib With or Without IMC-A12 in Patients With HER2 Positive Breast Cancer Previously Treated With Trastuzumab and an Anthracycline and/or a Taxane

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Recurrent Breast Carcinoma

Clinical Trials on Quality-of-Life Assessment

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations