Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive
Endocrine Therapy With or Without Inhibition of EGF and HER2 Growth Factor Receptors: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Fulvestrant With or Without Lapatinib (GW572016) for Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer
5 other identifiers
interventional
295
1 country
368
Brief Summary
This randomized phase III trial studies fulvestrant and lapatinib to see how well they work compared to fulvestrant and a placebo in treating postmenopausal women with stage III or stage IV breast cancer that is hormone receptor-positive. Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of breast cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether fulvestrant is more effective with or without lapatinib in treating breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2006
Longer than P75 for phase_3
368 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 15, 2006
CompletedFirst Submitted
Initial submission to the registry
October 18, 2006
CompletedFirst Posted
Study publicly available on registry
October 19, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2014
CompletedResults Posted
Study results publicly available
June 17, 2015
CompletedDecember 20, 2019
November 1, 2019
7.8 years
October 18, 2006
June 1, 2015
December 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival (PFS)
PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first. Progression is defined as a 20% increase in the sum of longest diameter of target lesions (per RECIST criteria).
Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years
Secondary Outcomes (2)
Objective Tumor Response Rate
Up to 5 years
Overall Survival (OS)
Study entry to death or last follow-up, up to 5 years
Other Outcomes (4)
Progression-free Survival for Participants With HER2-negative Tumors
Up to 5 years
Progression-free Survival for Participants With HER2-positive Tumors
Up to 5 years
Objective Tumor Response Rate for Participants With HER2-negative Tumors
Up to 5 years
- +1 more other outcomes
Study Arms (2)
Arm I (lapatinib)
EXPERIMENTALPatients receive lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 and 15 of course 1 and on day 1 of each subsequent course. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Arm II (placebo)
PLACEBO COMPARATORPatients receive placebo PO QD on days 1-28 and fulvestrant as in Arm I. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
Given IM
Eligibility Criteria
You may qualify if:
- Histologic, pathologic or cytologic diagnosis of cancer of the female breast in either primary or metastatic setting; histological documentation of metastatic/recurrent disease is not required if there is unequivocal clinical evidence for recurrence
- Stage IV breast cancer (using American Joint Committee on Cancer \[AJCC\] criteria, 6th edition), or locally advanced (stage III) breast cancer not considered amenable to curative therapy
- Patients with symptomatic brain metastases or other symptomatic central nervous system (CNS) metastases are not eligible for the study; no screening studies are required among asymptomatic patients; patients with previously treated brain metastases, who are free of symptoms referable to CNS disease and who are \> 3 months from treatment for brain metastases are eligible
- Tumors (as determined on pathology from either primary or metastatic sites) must be potentially sensitive to endocrine therapy, defined as expressing estrogen receptor (ER) and/or progesterone receptor (PgR) as determined immunohistochemical methods according to the local institution's standard protocol, \>= 1% cells will be considered to be positive
- The protocol has been amended to permit tumors with any HER2 status, though a determination of HER2 status must have been made; patients will be considered to be eligible if HER2 expression is documented by one of the following methods:
- Immunohistochemistry (IHC) 0 (i.e., negative), 1+, 2+, or 3+ levels of expression, or
- Gene amplification (fluorescent in situ hybridization \[FISH\]) positive or negative
- Patients must have at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as \>= 2.0 cm with conventional techniques or as \>= 1.0 cm with spiral computed tomography (CT) scan
- Exception: Patients with lytic or blastic bone metastases as their only site of disease will be eligible for the study even though these patients are not considered to have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria; these patients will be evaluable for time to progression, but not response
- Patients with all other lesions, including small lesions (longest diameter \< 2.0 cm with conventional techniques or \< 1.0 cm with spiral CT scan) and truly non-measurable lesions including those listed below are not eligible
- Lesions that are considered non-measurable include the following:
- Bone lesions (women with bone lesions will be eligible as described above)
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- +37 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (368)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Arroyo Grande Community
Arroyo Grande, California, 93420, United States
PCR Oncology
Arroyo Grande, California, 93420, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California, 91505, United States
East Bay Radiation Oncology Center
Castro Valley, California, 94546, United States
Eden Hospital Medical Center
Castro Valley, California, 94546, United States
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, 94546, United States
Bay Area Breast Surgeons Inc
Emeryville, California, 94608, United States
Valley Medical Oncology Consultants-Fremont
Fremont, California, 94538, United States
Glendale Memorial Hospital and Health Center
Glendale, California, 91204, United States
Saint Rose Hospital
Hayward, California, 94545, United States
Fremont - Rideout Cancer Center
Marysville, California, 95901, United States
El Camino Hospital
Mountain View, California, 94040, United States
Palo Alto Medical Foundation-Camino Division
Mountain View, California, 94040, United States
Highland General Hospital
Oakland, California, 94602, United States
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, 94609, United States
Bay Area Tumor Institute
Oakland, California, 94609, United States
Hematology and Oncology Associates-Oakland
Oakland, California, 94609, United States
Tom K Lee Inc
Oakland, California, 94609, United States
Valley Care Health System - Pleasanton
Pleasanton, California, 94588, United States
Valley Medical Oncology Consultants
Pleasanton, California, 94588, United States
University of California Davis Comprehensive Cancer Center
Sacramento, California, 95817, United States
Salinas Valley Memorial
Salinas, California, 93901, United States
Kaiser Permanente-San Diego Mission
San Diego, California, 92108, United States
Zuckerberg San Francisco General Hospital
San Francisco, California, 94110, United States
UCSF Medical Center-Mount Zion
San Francisco, California, 94115, United States
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, 94806, United States
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee, California, 96161, United States
Northbay Cancer Center
Vacaville, California, 95687, United States
UCHealth Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
Poudre Valley Hospital
Fort Collins, Colorado, 80524, United States
Saint Vincent's Medical Center
Bridgeport, Connecticut, 06606, United States
Yale University
New Haven, Connecticut, 06520, United States
Smilow Cancer Hospital-Torrington Care Center
Torrington, Connecticut, 06790, United States
Harold Leever Regional Cancer Center
Waterbury, Connecticut, 06708, United States
Beebe Medical Center
Lewes, Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware, 19718, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016, United States
Boca Raton Regional Hospital
Boca Raton, Florida, 33486, United States
Saint Luke's Mountain States Tumor Institute
Boise, Idaho, 83712, United States
Portneuf Medical Center
Pocatello, Idaho, 83201, United States
Saint Anthony's Health
Alton, Illinois, 62002, United States
Rush - Copley Medical Center
Aurora, Illinois, 60504, United States
Saint Joseph Medical Center
Bloomington, Illinois, 61701, United States
Graham Hospital Association
Canton, Illinois, 61520, United States
Memorial Hospital
Carthage, Illinois, 62321, United States
University of Illinois
Chicago, Illinois, 60612, United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Heartland Cancer Research NCORP
Decatur, Illinois, 62526, United States
Eureka Hospital
Eureka, Illinois, 61530, United States
Galesburg Cottage Hospital
Galesburg, Illinois, 61401, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois, 61401, United States
Mason District Hospital
Havana, Illinois, 62644, United States
Hopedale Medical Complex - Hospital
Hopedale, Illinois, 61747, United States
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, 60435, United States
Presence Saint Mary's Hospital
Kankakee, Illinois, 60901, United States
Kewanee Hospital
Kewanee, Illinois, 61443, United States
AMITA Health Adventist Medical Center
La Grange, Illinois, 60525, United States
Mcdonough District Hospital
Macomb, Illinois, 61455, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, 62864, United States
Bromenn Regional Medical Center
Normal, Illinois, 61761, United States
Community Cancer Center Foundation
Normal, Illinois, 61761, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, 61350, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin, Illinois, 61554, United States
Pekin Hospital
Pekin, Illinois, 61554, United States
Proctor Hospital
Peoria, Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria, Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria, Illinois, 61637, United States
Illinois Valley Hospital
Peru, Illinois, 61354, United States
Valley Radiation Oncology
Peru, Illinois, 61354, United States
Perry Memorial Hospital
Princeton, Illinois, 61356, United States
West Suburban Medical Center
River Forest, Illinois, 60305, United States
OSF Saint Anthony Medical Center
Rockford, Illinois, 61108, United States
Saint Margaret's Hospital
Spring Valley, Illinois, 61362, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Carle Cancer Center
Urbana, Illinois, 61801, United States
Franciscan Saint Francis Health-Beech Grove
Beech Grove, Indiana, 46107, United States
Elkhart Clinic
Elkhart, Indiana, 46514-2098, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, 46845, United States
Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Community Cancer Center East
Indianapolis, Indiana, 46219, United States
Community Cancer Center North
Indianapolis, Indiana, 46256, United States
Community Howard Regional Health
Kokomo, Indiana, 46904, United States
IU Health La Porte Hospital
La Porte, Indiana, 46350, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, 46360, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, 46545, United States
Reid Health
Richmond, Indiana, 47374, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, 46601, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46628, United States
McFarland Clinic PC - Ames
Ames, Iowa, 50010, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, 52722, United States
Mercy Hospital
Cedar Rapids, Iowa, 52403, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, 52403, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, 50325, United States
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, 51503, United States
Genesis Medical Center - East Campus
Davenport, Iowa, 52803, United States
Genesis Cancer Care Institute
Davenport, Iowa, 52804, United States
Mercy Capitol
Des Moines, Iowa, 50307, United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242, United States
Mercy Medical Center - North Iowa
Mason City, Iowa, 50401, United States
Ottumwa Regional Health Center
Ottumwa, Iowa, 52501, United States
Siouxland Regional Cancer Center
Sioux City, Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City, Iowa, 51102, United States
Saint Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Hospital District Sixth of Harper County
Anthony, Kansas, 67003, United States
Cancer Center of Kansas - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
Cancer Center of Kansas-Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Southwest Medical Center
Liberal, Kansas, 67901, United States
Cancer Center of Kansas-Liberal
Liberal, Kansas, 67905, United States
Cancer Center of Kansas - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas - Parsons
Parsons, Kansas, 67357, United States
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, 66762, United States
Cancer Center of Kansas - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina, Kansas, 67401, United States
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas, 66606, United States
Cancer Center of Kansas - Wellington
Wellington, Kansas, 67152, United States
Associates In Womens Health
Wichita, Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita, Kansas, 67208, United States
Ascension Via Christi Hospitals Wichita
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Wichita
Wichita, Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield, Kansas, 67156, United States
Doctors Carrol, Sheth, Raghavan
Louisville, Kentucky, 40215, United States
Baton Rouge General Medical Center
Baton Rouge, Louisiana, 70806, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112, United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
York Hospital
York Village, Maine, 03909, United States
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, 21201, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Saint Agnes Hospital
Baltimore, Maryland, 21229, United States
University of Maryland Shore Medical Center at Easton
Easton, Maryland, 21601, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, United States
Frederick Memorial Hospital
Frederick, Maryland, 21701, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Saint Anne's Hospital
Fall River, Massachusetts, 02721, United States
Addison Gilbert Hospital
Gloucester, Massachusetts, 01930, United States
Lowell General Hospital
Lowell, Massachusetts, 01854, United States
UMass Memorial Medical Center - University Campus
Worcester, Massachusetts, 01655, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
Bronson Battle Creek
Battle Creek, Michigan, 49017, United States
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, 49307, United States
Green Bay Oncology - Escanaba
Escanaba, Michigan, 49829, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids, Michigan, 49503, United States
Mercy Health Saint Mary's
Grand Rapids, Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503, United States
Holland Community Hospital
Holland, Michigan, 49423, United States
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, 49801, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007, United States
Borgess Medical Center
Kalamazoo, Michigan, 49048, United States
Mid-Michigan Medical Center - Midland
Midland, Michigan, 48670, United States
Mercy Health Partners-Hackley Campus
Muskegon, Michigan, 49442, United States
Mercy Health Mercy Campus
Muskegon, Michigan, 49444, United States
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, 48073, United States
Lakeland Medical Center Saint Joseph
Saint Joseph, Michigan, 49085, United States
Marie Yeager Cancer Center
Saint Joseph, Michigan, 49085, United States
Oncology Care Associates PLLC
Saint Joseph, Michigan, 49085, United States
Munson Medical Center
Traverse City, Michigan, 49684, United States
Metro Health Hospital
Wyoming, Michigan, 49519, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Essentia Health Cancer Center
Duluth, Minnesota, 55805, United States
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, 55805, United States
Miller-Dwan Hospital
Duluth, Minnesota, 55805, United States
Saint Luke's Hospital of Duluth
Duluth, Minnesota, 55805, United States
Fairview-Southdale Hospital
Edina, Minnesota, 55435, United States
Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Meeker County Memorial Hospital
Litchfield, Minnesota, 55355, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Virginia Piper Cancer Institute
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415, United States
North Memorial Medical Health Center
Robbinsdale, Minnesota, 55422, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Saint Joseph's Hospital - Healtheast
Saint Paul, Minnesota, 55102, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125, United States
Woodwinds Health Campus
Woodbury, Minnesota, 55125, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Keesler Medical Center
Keesler Air Force Base, Mississippi, 39534, United States
Southeast Missouri Hospital
Cape Girardeau, Missouri, 63701, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, 63703, United States
Saint Luke's Hospital
Chesterfield, Missouri, 63017, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
University of Missouri - Ellis Fischel
Columbia, Missouri, 65212, United States
Freeman Health System
Joplin, Missouri, 64804, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Missouri Baptist Medical Center
St Louis, Missouri, 63131, United States
Center for Cancer Care and Research
St Louis, Missouri, 63141, United States
Mercy Hospital Saint Louis
St Louis, Missouri, 63141, United States
Saint Louis-Cape Girardeau CCOP
St Louis, Missouri, 63141, United States
Billings Clinic Cancer Center
Billings, Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101, United States
Saint Vincent Healthcare
Billings, Montana, 59101, United States
Montana Cancer Consortium NCORP
Billings, Montana, 59102, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, 59102, United States
Bozeman Deaconess Hospital
Bozeman, Montana, 59715, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, 59701, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls, Montana, 59405, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, 59405, United States
Great Falls Clinic
Great Falls, Montana, 59405, United States
Saint Peter's Community Hospital
Helena, Montana, 59601, United States
Glacier Oncology PLLC
Kalispell, Montana, 59901, United States
Kalispell Medical Oncology
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Montana Cancer Specialists
Missoula, Montana, 59802, United States
Saint Patrick Hospital - Community Hospital
Missoula, Montana, 59802, United States
Community Medical Hospital
Missoula, Montana, 59804, United States
Guardian Oncology and Center for Wellness
Missoula, Montana, 59804, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102, United States
New Hampshire Oncology Hematology PA-Concord
Concord, New Hampshire, 03301, United States
New Hampshire Oncology Hematology PA-Hooksett
Hooksett, New Hampshire, 03106, United States
LRGHealthcare-Lakes Region General Hospital
Laconia, New Hampshire, 03246, United States
Elliot Hospital
Manchester, New Hampshire, 03103, United States
Cooper Hospital University Medical Center
Camden, New Jersey, 08103, United States
Saint Barnabas Medical Center
Livingston, New Jersey, 07039, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
Virtua Memorial
Mount Holly, New Jersey, 08060, United States
Overlook Hospital
Summit, New Jersey, 07902, United States
Saint Francis Medical Center
Trenton, New Jersey, 08629, United States
Inspira Medical Center Vineland
Vineland, New Jersey, 08360, United States
Virtua Voorhees
Voorhees Township, New Jersey, 08043, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Hematology Oncology Associates of Central New York-East Syracuse
East Syracuse, New York, 13057, United States
Northern Westchester Hospital
Mount Kisco, New York, 10549, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Staten Island University Hospital
Staten Island, New York, 10305, United States
State University of New York Upstate Medical University
Syracuse, New York, 13210, United States
Mission Hospital
Asheville, North Carolina, 28801, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
CaroMont Regional Medical Center
Gastonia, North Carolina, 28054, United States
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, 27534, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534, United States
Maria Parham Hospital
Henderson, North Carolina, 27536, United States
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, 28791, United States
Vidant Oncology-Kinston
Kinston, North Carolina, 28501, United States
Southeastern Regional Medical Center
Lumberton, North Carolina, 28358, United States
Granville Medical Center
Oxford, North Carolina, 27565, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, 28374, United States
Duke Raleigh Hospital
Raleigh, North Carolina, 27609, United States
Person Memorial Hospital
Roxboro, North Carolina, 27573, United States
Rutherford Hospital
Rutherfordton, North Carolina, 28139, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
Mid Dakota Clinic
Bismarck, North Dakota, 58501, United States
Saint Alexius Medical Center
Bismarck, North Dakota, 58501, United States
Sanford Bismarck Medical Center
Bismarck, North Dakota, 58501, United States
Altru Cancer Center
Grand Forks, North Dakota, 58201, United States
Trinity Cancer Care Center
Minot, North Dakota, 58701, United States
Cleveland Clinic Akron General
Akron, Ohio, 44307, United States
Mary Rutan Hospital
Bellefontaine, Ohio, 43311, United States
Aultman Health Foundation
Canton, Ohio, 44710, United States
Adena Regional Medical Center
Chillicothe, Ohio, 45601, United States
Case Western Reserve University
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
Mount Carmel Health Center West
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital - Dayton
Dayton, Ohio, 45406, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Miami Valley Hospital North
Dayton, Ohio, 45415, United States
Dayton Veterans Affairs Medical Center
Dayton, Ohio, 45428, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Blanchard Valley Hospital
Findlay, Ohio, 45840, United States
Atrium Medical Center-Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio, 44131, United States
Kettering Medical Center
Kettering, Ohio, 45429, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
Saint Rita's Medical Center
Lima, Ohio, 45801, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Springfield Regional Medical Center
Springfield, Ohio, 45505, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
Saint Ann's Hospital
Westerville, Ohio, 43081, United States
Clinton Memorial Hospital
Wilmington, Ohio, 45177, United States
Cleveland Clinic Wooster Family Health and Surgery Center
Wooster, Ohio, 44691, United States
Wright-Patterson Medical Center
Wright-Patterson Air Force Base, Ohio, 45433-5529, United States
Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, 43701, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
Saint Mary Medical and Regional Cancer Center
Langhorne, Pennsylvania, 19047, United States
AnMed Health Hospital
Anderson, South Carolina, 29621, United States
Saint Francis Hospital
Greenville, South Carolina, 29601, United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina, 29615, United States
Spartanburg Medical Center
Spartanburg, South Carolina, 29303, United States
Avera Cancer Institute-Aberdeen
Aberdeen, South Dakota, 57401, United States
Rapid City Regional Hospital
Rapid City, South Dakota, 57701, United States
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, 57105, United States
Medical X-Ray Center
Sioux Falls, South Dakota, 57105, United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134, United States
Wellmont Holston Valley Hospital and Medical Center
Kingsport, Tennessee, 37660, United States
University of Tennessee - Knoxville
Knoxville, Tennessee, 37920, United States
University of Tennessee Health Science Center
Memphis, Tennessee, 38163, United States
American Fork Hospital / Huntsman Intermountain Cancer Center
American Fork, Utah, 84003, United States
Sandra L Maxwell Cancer Center
Cedar City, Utah, 84720, United States
Logan Regional Hospital
Logan, Utah, 84321, United States
Cottonwood Hospital Medical Center
Murray, Utah, 84107, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
McKay-Dee Hospital Center
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Intermountain Health Care
Salt Lake City, Utah, 84103, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Dixie Medical Center Regional Cancer Center
St. George, Utah, 84770, United States
Central Vermont Medical Center/National Life Cancer Treatment
Berlin Corners, Vermont, 05602, United States
University of Vermont and State Agricultural College
Burlington, Vermont, 05405, United States
Danville Regional Medical Center
Danville, Virginia, 24541, United States
Southwest VA Regional Cancer Center
Norton, Virginia, 24273, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298, United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225, United States
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, 98310, United States
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, 99336, United States
Skagit Valley Hospital
Mount Vernon, Washington, 98274, United States
Minor and James Medical PLLC
Seattle, Washington, 98104, United States
Kaiser Permanente Washington
Seattle, Washington, 98112, United States
Swedish Medical Center-First Hill
Seattle, Washington, 98122-4307, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
Evergreen Hematology and Oncology PS
Spokane, Washington, 99218, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, 54301-3526, United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, 54303, United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303, United States
Mercyhealth Hospital and Cancer Center - Janesville
Janesville, Wisconsin, 53548, United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601, United States
Dean Hematology and Oncology Clinic
Madison, Wisconsin, 53717, United States
Holy Family Memorial Hospital
Manitowoc, Wisconsin, 54221, United States
Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Welch Cancer Center
Sheridan, Wyoming, 82801, United States
Related Publications (1)
Burstein HJ, Cirrincione CT, Barry WT, Chew HK, Tolaney SM, Lake DE, Ma C, Blackwell KL, Winer EP, Hudis CA. Endocrine therapy with or without inhibition of epidermal growth factor receptor and human epidermal growth factor receptor 2: a randomized, double-blind, placebo-controlled phase III trial of fulvestrant with or without lapatinib for postmenopausal women with hormone receptor-positive advanced breast cancer-CALGB 40302 (Alliance). J Clin Oncol. 2014 Dec 10;32(35):3959-66. doi: 10.1200/JCO.2014.56.7941. Epub 2014 Oct 27.
PMID: 25348000DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Harold Burstein, M.D.
- Organization
- Dana-Farber Cancer Institue
Study Officials
- PRINCIPAL INVESTIGATOR
Harold J Burstein
Alliance for Clinical Trials in Oncology
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2006
First Posted
October 19, 2006
Study Start
September 15, 2006
Primary Completion
July 1, 2014
Study Completion
July 2, 2014
Last Updated
December 20, 2019
Results First Posted
June 17, 2015
Record last verified: 2019-11