AzTrials
AzTrials

Estrogen Receptor PositivePhase 3NCT00390455

Fulvestrant With or Without Lapatinib in Treating Postmenopausal Women With Stage III or Stage IV Breast Cancer That is Hormone Receptor-Positive

A Phase 3 study testing Fulvestrant, Laboratory Biomarker Analysis and Lapatinib Ditosylate in people with Estrogen Receptor Positive and HER2 Positive Breast Carcinoma, run by National Cancer Institute (NCI) at 368 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Fulvestrant, Laboratory Biomarker Analysis and Lapatinib Ditosylate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
295 participants
Where
368 sitesUnited States
Study dates
15 Sep 2006to 2 Jul 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Inflammatory breast cancer
  • Lymphangitis cutis/pulmonitis
  • Abdominal masses that are not confirmed and followed by imaging techniques
  • Cystic lesions
  • Patients must have had one or two prior endocrine treatments for breast cancer in either the adjuvant or metastatic setting, exclusive of treatment-related amenorrhea or ovarian suppression; sequential use of two different third-generation aromatase inhibitors is considered "one" treatment; it is not required that tumors be resistant to such treatments; for example:
  • A patient with de novo metastatic breast cancer who had never received endocrine therapy is not eligible;
  • A patient who received adjuvant tamoxifen and subsequent therapy with an aromatase inhibitor (adjuvant or metastatic) is eligible;
  • A patient who received an aromatase inhibitor in either the adjuvant or metastatic setting, and who discontinued therapy after several months because of side effects, is eligible;
  • A patient who received an aromatase inhibitor in the adjuvant setting is eligible, regardless of whether they did or did not receive tamoxifen at some point;
  • A patient who received adjuvant tamoxifen, and subsequently a nonsteroidal aromatase inhibitor and a steroidal aromatase inhibitor for advanced breast cancer in the adjuvant or metastatic setting is eligible;
  • A patient who received adjuvant tamoxifen, and then a nonsteroidal aromatase inhibitor and subsequently megesterol acetate for advanced breast cancer is not eligible
  • Tumors potentially sensitive to endocrine therapy, defined as >= 3 months of prior endocrine therapy without disease progression in the adjuvant or metastatic setting
  • Patients must have had prior treatment in either the adjuvant or metastatic setting with a commercially available third-generation aromatase inhibitor (i.e. anastrozole, exemestane, or letrozole); it is not required that tumors be resistant to such therapies
  • Patients may have received up to one prior chemotherapy regimen for stage IV breast cancer; prior chemotherapy in the adjuvant and/or neoadjuvant setting is permitted; patients must have finished chemotherapy at least 1 week prior to starting protocol based treatment
  • Patients may have received prior trastuzumab therapy for stage IV breast cancer, in combination with up to one chemotherapy and/or endocrine therapy regimen, but that must have concluded at least 3 weeks prior to starting protocol-based therapy; prior trastuzumab therapy in the adjuvant and/or neoadjuvant setting is permitted, but must have concluded at least 3 weeks prior to starting protocol-based therapy
  • Prior therapy with commercially available inhibitor of EGFR (including but not limited to gefitinib, erlotinib, lapatinib or cetuximab) or experimental inhibitors of EGFR is prohibited
  • Patients may have initiated bisphosphonate therapy prior to study entry; such patients will have bone lesions considered evaluable for progression but not for response
  • Prior fulvestrant therapy is prohibited
  • Patients receiving a gonadotropin-releasing hormone (GnRH) agonist for ovarian suppression must remain on such therapy throughout the course of protocol treatment; patients must discontinue other endocrine treatments, including systemic hormone-replacement therapy and intravaginal estrogens prior to study entry; patients must have concluded radiation therapy prior to study entry; patients must be at least 1 week from prior chemotherapy or 3 weeks from prior trastuzumab therapy, with adequate recovery of bone marrow function and performance status
  • Patients must be postmenopausal women, defined as a woman fulfilling any of the following criteria:
  • Age >= 60 years; or
  • Age >= 45 years with an intact uterus and amenorrhea for 12 months or more; or
  • History of bilateral oophorectomy; or
  • Follicle stimulating hormone (FSH) levels within postmenopausal range according to the ranges established by the testing facility; or
  • Treatment with a GnRH agonist for ovarian suppression for at least 3 consecutive months prior to study registration, and remaining on such therapy throughout the course of protocol treatment
  • Women who are pregnant or nursing are not eligible for the study; clinicians should advise patients that there are no data for the safety of lapatinib or fulvestrant among pregnant patients, nor data on the impact of these agents on fertility or pregnancy
  • Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-2
  • Absence of pending visceral crisis, in the opinion of the treating physician
  • Absence of acquired or inherited bleeding disorder
  • Absence of need for therapeutic systemic anticoagulation (defined as maintaining international normalized ratio [INR] > 1.6); patients may take low-dose warfarin or aspirin (or equivalent) for maintenance of central venous catheter patency
  • Granulocytes >= 1,000/μl
  • Platelet count >= 100,000/μl
  • Creatinine =< 2 mg/dl
  • Total bilirubin =< 1.5 x upper limits of normal (ULN) unless due to Gilbert's syndrome
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x ULN without liver metastases; =< 5 x ULN with liver metastases
  • INR =< 1.6
  • Left ventricular ejection fraction (LVEF) within institutional limits of normal

Who cannot join

None listed.

Trial locations and contacts

368 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Avera Cancer Institute-Aberdeen

    Aberdeen, South Dakota, 57401

  • Abington Memorial Hospital

    Abington, Pennsylvania, 19001

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • Saint Anthony's Health

    Alton, Illinois, 62002

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • McFarland Clinic PC - Ames

    Ames, Iowa, 50010

  • AnMed Health Hospital

    Anderson, South Carolina, 29621

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

  • Hospital District Sixth of Harper County

    Anthony, Kansas, 67003

  • Arroyo Grande Community

    Arroyo Grande, California, 93420

  • PCR Oncology

    Arroyo Grande, California, 93420

  • Mission Hospital

    Asheville, North Carolina, 28801

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Greater Baltimore Medical Center

    Baltimore, Maryland, 21204

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Baton Rouge General Medical Center

    Baton Rouge, Louisiana, 70806

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Franciscan Saint Francis Health-Beech Grove

    Beech Grove, Indiana, 46107

  • Mary Rutan Hospital

    Bellefontaine, Ohio, 43311

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

  • Spectrum Health Big Rapids Hospital

    Big Rapids, Michigan, 49307

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59102

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Mid Dakota Clinic

    Bismarck, North Dakota, 58501

  • Saint Alexius Medical Center

    Bismarck, North Dakota, 58501

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Saint Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Saint Vincent's Medical Center

    Bridgeport, Connecticut, 06606

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Graham Hospital Association

    Canton, Illinois, 61520

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Southeast Missouri Hospital

    Cape Girardeau, Missouri, 63701

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital

    Carthage, Illinois, 62321

  • East Bay Radiation Oncology Center

    Castro Valley, California, 94546

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

  • Valley Medical Oncology Consultants-Castro Valley

    Castro Valley, California, 94546

  • Sandra L Maxwell Cancer Center

    Cedar City, Utah, 84720

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • UNC Lineberger Comprehensive Cancer Center

    Chapel Hill, North Carolina, 27599

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Missouri Cancer Associates

    Columbia, Missouri, 65201

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Heartland Oncology and Hematology LLP

    Council Bluffs, Iowa, 51503

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Genesis Medical Center - East Campus

    Davenport, Iowa, 52803

  • Genesis Cancer Care Institute

    Davenport, Iowa, 52804

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Dayton Veterans Affairs Medical Center

    Dayton, Ohio, 45428

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Heartland Cancer Research NCORP

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Mercy Capitol

    Des Moines, Iowa, 50307

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa-Wide Oncology Research Coalition NCORP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Saint Luke's Hospital of Duluth

    Duluth, Minnesota, 55805

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

  • University of Maryland Shore Medical Center at Easton

    Easton, Maryland, 21601

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital of Cecil County

    Elkton, Maryland, 21921

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49829

  • Eureka Hospital

    Eureka, Illinois, 61530

  • Saint Anne's Hospital

    Fall River, Massachusetts, 02721

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Fort Wayne Medical Oncology and Hematology Inc-Parkview

    Fort Wayne, Indiana, 46845

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Frederick Memorial Hospital

    Frederick, Maryland, 21701

  • Valley Medical Oncology Consultants-Fremont

    Fremont, California, 94538

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Galesburg Cottage Hospital

    Galesburg, Illinois, 61401

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • CaroMont Regional Medical Center

    Gastonia, North Carolina, 28054

  • Glendale Memorial Hospital and Health Center

    Glendale, California, 91204

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

  • Cancer Research Consortium of West Michigan NCORP

    Grand Rapids, Michigan, 49503

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Berdeaux, Donald MD (UIA Investigator)

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Mason District Hospital

    Havana, Illinois, 62644

  • Saint Rose Hospital

    Hayward, California, 94545

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Maria Parham Hospital

    Henderson, North Carolina, 27536

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Holland Community Hospital

    Holland, Michigan, 49423

  • New Hampshire Oncology Hematology PA-Hooksett

    Hooksett, New Hampshire, 03106

  • Hopedale Medical Complex - Hospital

    Hopedale, Illinois, 61747

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio, 44131

  • Community Cancer Center East

    Indianapolis, Indiana, 46219

  • Community Cancer Center North

    Indianapolis, Indiana, 46256

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Green Bay Oncology - Iron Mountain

    Iron Mountain, Michigan, 49801

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Mercyhealth Hospital and Cancer Center - Janesville

    Janesville, Wisconsin, 53548

  • Joliet Oncology-Hematology Associates Limited

    Joliet, Illinois, 60435

  • Freeman Health System

    Joplin, Missouri, 64804

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048

  • Glacier Oncology PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Presence Saint Mary's Hospital

    Kankakee, Illinois, 60901

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Keesler Medical Center

    Keesler Air Force Base, Mississippi, 39534

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Kewanee Hospital

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • Vidant Oncology-Kinston

    Kinston, North Carolina, 28501

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • AMITA Health Adventist Medical Center

    La Grange, Illinois, 60525

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • LRGHealthcare-Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Saint Mary Medical and Regional Cancer Center

    Langhorne, Pennsylvania, 19047

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Saint Rita's Medical Center

    Lima, Ohio, 45801

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Saint Barnabas Medical Center

    Livingston, New Jersey, 07039

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Doctors Carrol, Sheth, Raghavan

    Louisville, Kentucky, 40215

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • Southeastern Regional Medical Center

    Lumberton, North Carolina, 28358

  • Mcdonough District Hospital

    Macomb, Illinois, 61455

  • Dean Hematology and Oncology Clinic

    Madison, Wisconsin, 53717

  • Elliot Hospital

    Manchester, New Hampshire, 03103

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54221

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Fremont - Rideout Cancer Center

    Marysville, California, 95901

  • Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • University of Tennessee Health Science Center

    Memphis, Tennessee, 38163

  • Franciscan Saint Anthony Health-Michigan City

    Michigan City, Indiana, 46360

  • Mid-Michigan Medical Center - Midland

    Midland, Michigan, 48670

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Virginia Piper Cancer Institute

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Trinity Cancer Care Center

    Minot, North Dakota, 58701

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545

  • Montana Cancer Specialists

    Missoula, Montana, 59802

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Community Medical Hospital

    Missoula, Montana, 59804

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Morristown Medical Center

    Morristown, New Jersey, 07960

  • Virtua Memorial

    Mount Holly, New Jersey, 08060

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Skagit Valley Hospital

    Mount Vernon, Washington, 98274

  • El Camino Hospital

    Mountain View, California, 94040

  • Palo Alto Medical Foundation-Camino Division

    Mountain View, California, 94040

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Mercy Health Partners-Hackley Campus

    Muskegon, Michigan, 49442

  • Mercy Health Mercy Campus

    Muskegon, Michigan, 49444

  • Yale University

    New Haven, Connecticut, 06520

  • Louisiana State University Health Science Center

    New Orleans, Louisiana, 70112

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Bromenn Regional Medical Center

    Normal, Illinois, 61761

  • Community Cancer Center Foundation

    Normal, Illinois, 61761

  • Southwest VA Regional Cancer Center

    Norton, Virginia, 24273

  • Highland General Hospital

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • Hematology and Oncology Associates-Oakland

    Oakland, California, 94609

  • Tom K Lee Inc

    Oakland, California, 94609

  • Saint Vincent Hospital Cancer Center at Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Ottawa Regional Hospital and Healthcare Center

    Ottawa, Illinois, 61350

  • Ottumwa Regional Health Center

    Ottumwa, Iowa, 52501

  • Granville Medical Center

    Oxford, North Carolina, 27565

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center

    Pekin, Illinois, 61554

  • Pekin Hospital

    Pekin, Illinois, 61554

  • Proctor Hospital

    Peoria, Illinois, 61614

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois Valley Hospital

    Peru, Illinois, 61354

  • Valley Radiation Oncology

    Peru, Illinois, 61354

  • FirstHealth of the Carolinas-Moore Regional Hospital

    Pinehurst, North Carolina, 28374

  • Via Christi Hospital-Pittsburg

    Pittsburg, Kansas, 66762

  • Valley Care Health System - Pleasanton

    Pleasanton, California, 94588

  • Valley Medical Oncology Consultants

    Pleasanton, California, 94588

  • Portneuf Medical Center

    Pocatello, Idaho, 83201

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Perry Memorial Hospital

    Princeton, Illinois, 61356

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • Duke Raleigh Hospital

    Raleigh, North Carolina, 27609

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Reid Health

    Richmond, Indiana, 47374

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • West Suburban Medical Center

    River Forest, Illinois, 60305

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • OSF Saint Anthony Medical Center

    Rockford, Illinois, 61108

  • Person Memorial Hospital

    Roxboro, North Carolina, 27573

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • University of California Davis Comprehensive Cancer Center

    Sacramento, California, 95817

  • Lakeland Medical Center Saint Joseph

    Saint Joseph, Michigan, 49085

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Oncology Care Associates PLLC

    Saint Joseph, Michigan, 49085

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Saint Joseph's Hospital - Healtheast

    Saint Paul, Minnesota, 55102

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Salinas Valley Memorial

    Salinas, California, 93901

  • Intermountain Health Care

    Salt Lake City, Utah, 84103

  • Utah Cancer Specialists-Salt Lake City

    Salt Lake City, Utah, 84106

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • LDS Hospital

    Salt Lake City, Utah, 84143

  • Kaiser Permanente-San Diego Mission

    San Diego, California, 92108

  • Zuckerberg San Francisco General Hospital

    San Francisco, California, 94110

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare the effect, in terms of progression free survival, of the antiestrogen fulvestrant alone with fulvestrant administered in combination with the dual-kinase inhibitor lapatinib for postmenopausal women with estrogen receptor (ER) and/or progesterone receptor (PgR) positive advanced breast cancer.

SECONDARY OBJECTIVES:

  1. To compare the effects of fulvestrant alone with fulvestrant and lapatinib on other clinical endpoints, including response rate, response and stable disease rate (complete response [CR] + partial response [PR] + stable disease >= 6 months), duration of response, overall survival, symptom checklist scores, and toxicity.

II. To define predictive markers of clinical activity among women receiving fulvestrant with or without lapatinib.

III. To determine if the clinical benefits for combination of hormonal and growth factor inhibitor therapy are most pronounced in women whose tumors express higher levels of ER, epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 2 (HER2), phosphorylated protein kinase B (pAkt), and/or phosphorylated mitogen-activated protein kinase 1/2 (pERK1/2).

IV. To serologically determine if HER2 extracellular domain (ECD) and EGFR ECD levels can identify patients with a greater likelihood of response and clinical benefit to fulvestrant with or without lapatinib.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive lapatinib ditosylate orally (PO) once daily (QD) on days 1-28 and fulvestrant intramuscularly (IM) on days 1 and 15 of course 1 and on day 1 of each subsequent course.

ARM II: Patients receive placebo PO QD on days 1-28 and fulvestrant as in Arm I.

In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for 2 years and then annually for 3 years.

Being tested
Fulvestrant, Laboratory Biomarker Analysis, Lapatinib Ditosylate, Placebo Administration
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FulvestrantDrug

    Also called Faslodex, Faslodex(ICI 182,780), ICI 182,780, ICI 182780

    Given IM

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Lapatinib DitosylateDrug

    Also called Tykerb

    Given PO

  • Placebo AdministrationOther

    Given PO

Study groups in NCT00390455
Study groupRoleWhat they receive
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.
Receives: Drug: Fulvestrant; Other: Laboratory Biomarker Analysis; Drug: Lapatinib Ditosylate
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.
Receives: Drug: Fulvestrant; Other: Laboratory Biomarker Analysis; Other: Placebo Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years

Secondary outcomes (2)

  1. Objective Tumor Response Rate

    Response was defined by the Response Evaluation Criteria in Solid Tumors (RECIST). A responding participant had either a Complete Response (disappearance of all target lesions) or Partial Response (30% decrease in sum of longest diameter of target lesions). The response rate of measurable tumors will be estimated with its 95% confidence interval according to treatment arm.

    Measured: Up to 5 years

  2. Overall Survival (OS)

    Overall survival was measured as the interval from study entry until death, from any cause, or last contact.

    Measured: Study entry to death or last follow-up, up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2006 (estimated)
  2. Study start15 Sep 2006
  3. Primary completion1 Jul 2014
  4. Study completion2 Jul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
295 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00390455
Sponsor's protocol ID
NCI-2009-00475
Other IDs
NCI-2009-00475, CDR0000510452, CALGB-40302, CALGB-40302, U10CA180821, U10CA031946
Status last verified
Nov 2019
First submitted
18 Oct 2006
Last updated
20 Dec 2019
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25348000

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fulvestrant, Laboratory Biomarker Analysis and Lapatinib Ditosylate in people with Estrogen Receptor Positive and HER2 Positive Breast Carcinoma, run by National Cancer Institute (NCI) at 368 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 52 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 368 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) (time frame: Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00390455, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.

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