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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00390455
First received: October 18, 2006
Last updated: June 1, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention Phase
Estrogen Receptor Positive
HER2 Positive Breast Carcinoma
HER2/Neu Negative
Progesterone Receptor Positive
Recurrent Breast Carcinoma
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Drug: Lapatinib Ditosylate
Drug: Fulvestrant
Other: Placebo
Other: Laboratory Biomarker Analysis
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Progression-free Survival (PFS) [ Time Frame: Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Objective Tumor Response Rate [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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.

  • Overall Survival (OS) [ Time Frame: Study entry to death or last follow-up, up to 5 years ] [ Designated as safety issue: No ]
    Overall survival was measured as the interval from study entry until death, from any cause, or last contact.


Other Outcome Measures:
  • Progression-free Survival for Participants With HER2-negative Tumors [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    PFS was defined as the interval from study entry until disease progression or death resulting from any cause, which ever occurred first.

  • Progression-free Survival for Participants With HER2-positive Tumors [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    PFS was defined as the interval from study entry until disease progression or death resulting from any cause, whichever occurred first.

  • Objective Tumor Response Rate for Participants With HER2-negative Tumors [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Response was defined by the 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.

  • Objective Tumor Response Rate for Participants With HER2-positive Tumors [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Response was defined by the 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.


Enrollment: 295
Study Start Date: September 2006
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (lapatinib)
Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
Drug: Lapatinib Ditosylate
Given PO
Other Names:
  • GSK572016
  • GW-572016
  • GW2016
  • Lapatinib
  • Tykerb
Drug: Fulvestrant
Given IM
Other Names:
  • ICI 182,780
  • ZD9238
Other: Laboratory Biomarker Analysis
Correlative studies
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
Drug: Fulvestrant
Given IM
Other Names:
  • ICI 182,780
  • ZD9238
Other: Placebo
Given PO
Other Name: PLCB
Other: Laboratory Biomarker Analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. 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:

I. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
      • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390455

  Hide Study Locations
Locations
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
East Bay Radiation Oncology Center
Castro Valley, California, United States, 94546
Eden Hospital Medical Center
Castro Valley, California, United States, 94546
Valley Medical Oncology Consultants-Castro Valley
Castro Valley, California, United States, 94546
Northbay Cancer Center
Fairfield, California, United States, 94533
Valley Medical Oncology Consultants-Fremont
Fremont, California, United States, 94538
Glendale Memorial Hospital and Health Center
Glendale, California, United States, 91204
Saint Rose Hospital
Hayward, California, United States, 94545
Fremont - Rideout Cancer Center
Marysville, California, United States, 95901
El Camino Hospital
Mountain View, California, United States, 94040
Palo Alto Medical Foundation-Camino Division
Mountain View, California, United States, 94040
Alta Bates Summit Medical Center - Summit Campus
Oakland, California, United States, 94609
Bay Area Breast Surgeons Inc
Oakland, California, United States, 94609
Bay Area Tumor Institute
Oakland, California, United States, 94609
Tom K Lee Inc
Oakland, California, United States, 94609
Larry G Strieff MD Medical Corporation
Oakland, California, United States, 94609
Highland General Hospital
Oakland, California, United States, 94602
Palchak David MD
Pismo Beach, California, United States, 93449
Valley Care Health System - Pleasanton
Pleasanton, California, United States, 94588
Valley Medical Oncology Consultants
Pleasanton, California, United States, 94588
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Kaiser Permanente
San Diego, California, United States, 92120
UCSF Medical Center-Mount Zion
San Francisco, California, United States, 94115
Doctors Medical Center- JC Robinson Regional Cancer Center
San Pablo, California, United States, 94806
Tahoe Forest Cancer Center
Truckee, California, United States, 96161
United States, Colorado
Memorial Hospital Colorado Springs
Colorado Springs, Colorado, United States, 80909
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06520
Charlotte Hungerford Hospital Center for Cancer Care
Torrington, Connecticut, United States, 06790
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
Christiana Care Health System-Christiana Hospital
Newark, Delaware, United States, 19718
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University
Washington, District of Columbia, United States, 20057
Sibley Memorial Hospital
Washington, District of Columbia, United States, 20016
United States, Florida
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486
United States, Idaho
Portneuf Medical Center
Pocatello, Idaho, United States, 83201
United States, Illinois
Rush - Copley Medical Center
Aurora, Illinois, United States, 60504
Saint Joseph Medical Center
Bloomington, Illinois, United States, 61701
Graham Hospital Association
Canton, Illinois, United States, 61520
Memorial Hospital
Carthage, Illinois, United States, 62321
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
University of Illinois
Chicago, Illinois, United States, 60612
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Eureka Hospital
Eureka, Illinois, United States, 61530
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401
Illinois CancerCare Galesburg
Galesburg, Illinois, United States, 61401
Western Illinois Cancer Treatment Center
Galesburg, Illinois, United States, 61401
Mason District Hospital
Havana, Illinois, United States, 62644
Hopedale Medical Complex - Hospital
Hopedale, Illinois, United States, 61747
Joliet Oncology-Hematology Associates Limited
Joliet, Illinois, United States, 60435
Kewanee Hospital
Kewanee, Illinois, United States, 61443
Mcdonough District Hospital
Macomb, Illinois, United States, 61455
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Bromenn Regional Medical Center
Normal, Illinois, United States, 61761
Community Cancer Center Foundation
Normal, Illinois, United States, 61761
Ottawa Regional Hospital and Healthcare Center
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois, United States, 61350
Pekin Cancer Treatment Center
Pekin, Illinois, United States, 61554
Pekin Hospital
Pekin, Illinois, United States, 61554
OSF Saint Francis Medical Center
Peoria, Illinois, United States, 61637
Illinois Oncology Research Association CCOP
Peoria, Illinois, United States, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61603
Proctor Hospital
Peoria, Illinois, United States, 61614
Illinois CancerCare-Peoria
Peoria, Illinois, United States, 61615
Valley Radiation Oncology
Peru, Illinois, United States, 61354
Illinois Valley Hospital
Peru, Illinois, United States, 61354
Perry Memorial Hospital
Princeton, Illinois, United States, 61356
Saint Anthony Medical Center
Rockford, Illinois, United States, 61108
Saint Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Cancer Center
Urbana, Illinois, United States, 61801
Carle Clinic-Urbana Main
Urbana, Illinois, United States, 61801
United States, Indiana
Elkhart Clinic
Elkhart, Indiana, United States, 46514-2098
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Fort Wayne Medical Oncology and Hematology Inc-Parkview
Fort Wayne, Indiana, United States, 46845
IU Health Goshen Center for Cancer Care
Goshen, Indiana, United States, 46526
Community Regional Cancer Care-East Medical Oncology
Indianapolis, Indiana, United States, 46219
Community Regional Cancer Care-East Radiation Oncology
Indianapolis, Indiana, United States, 46219
Community Regional Cancer Care-North
Indianapolis, Indiana, United States, 46256
Community Howard Regional Health
Kokomo, Indiana, United States, 46904
IU Health La Porte Hospital
La Porte, Indiana, United States, 46350
Franciscan Saint Anthony Health-Michigan City
Michigan City, Indiana, United States, 46360
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka, Indiana, United States, 46545
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46628
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC-South Bend
South Bend, Indiana, United States, 46601
United States, Iowa
McFarland Clinic PC-William R Bliss Cancer Center
Ames, Iowa, United States, 50010
Hematology Oncology Associates-Quad Cities
Bettendorf, Iowa, United States, 52722
Cedar Rapids Oncology Association
Cedar Rapids, Iowa, United States, 52403
Mercy Hospital
Cedar Rapids, Iowa, United States, 52403
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
Medical Oncology and Hematology Associates-West Des Moines
Clive, Iowa, United States, 50325
Heartland Oncology and Hematology LLP
Council Bluffs, Iowa, United States, 51503
Genesis Medical Center - East Campus
Davenport, Iowa, United States, 52803
Genesis Medical Center - West Campus
Davenport, Iowa, United States, 52804
Iowa Oncology Research Association CCOP
Des Moines, Iowa, United States, 50309
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Medical Oncology and Hematology Associates-Des Moines
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel
Des Moines, Iowa, United States, 50314
Mercy Capitol
Des Moines, Iowa, United States, 50307
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Medical Center-Sioux City
Sioux City, Iowa, United States, 51104
Saint Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Hematology Oncology Associates
Sioux City, Iowa, United States, 51101
United States, Kansas
Hospital District Sixth of Harper County
Anthony, Kansas, United States, 67003
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Via Christi Hospital-Pittsburg
Pittsburg, Kansas, United States, 66762
Stormont-Vail Regional Health Center
Topeka, Kansas, United States, 66604
United States, Kentucky
Doctors Carrol, Sheth, Raghavan
Louisville, Kentucky, United States, 40215
United States, Louisiana
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, United States, 70809
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70806
Interim LSU Public Hospital
New Orleans, Louisiana, United States, 70112
Louisiana State University Health Science Center
New Orleans, Louisiana, United States, 70112
United States, Maine
Eastern Maine Medical Center
Bangor, Maine, United States, 04401
York Hospital
York, Maine, United States, 03909
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Memorial Hospital at Easton - Shore Regional Cancer Center
Easton, Maryland, United States, 21601
The Memorial Hospital at Easton
Easton, Maryland, United States, 21601
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
Frederick Memorial Hospital
Frederick, Maryland, United States, 21701
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Lowell General Hospital
Lowell, Massachusetts, United States, 01854
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
University of Michigan University Hospital
Ann Arbor, Michigan, United States, 48109
Bronson Battle Creek
Battle Creek, Michigan, United States, 49017
Spectrum Health Big Rapids Hospital
Big Rapids, Michigan, United States, 49307
Green Bay Oncology - Escanaba
Escanaba, Michigan, United States, 49431
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
Mercy Health Saint Mary's
Grand Rapids, Michigan, United States, 49503
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, United States, 49503
Holland Community Hospital
Holland, Michigan, United States, 49423
Green Bay Oncology - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Mid-Michigan Medical Center - Midland
Midland, Michigan, United States, 48670
Mercy Health Mercy Campus
Muskegon, Michigan, United States, 49444
Mercy Health Partners-Hackley Campus
Muskegon, Michigan, United States, 49442
William Beaumont Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Marie Yeager Cancer Center
Saint Joseph, Michigan, United States, 49085
Lakeland Hospital
St. Joseph, Michigan, United States, 49085
Munson Medical Center
Traverse City, Michigan, United States, 49684
Metro Health Hospital
Wyoming, Michigan, United States, 49519
United States, Minnesota
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Miller-Dwan Hospital
Duluth, Minnesota, United States, 55805
Essentia Health Saint Mary's Medical Center
Duluth, Minnesota, United States, 55805
Essentia Health Cancer Center
Duluth, Minnesota, United States, 55805
Fairview-Southdale Hospital
Edina, Minnesota, United States, 55435
Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Litchfield, Minnesota, United States, 55355
Saint John's Hospital - Healtheast
Maplewood, Minnesota, United States, 55109
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, United States, 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
North Memorial Medical Health Center
Robbinsdale, Minnesota, United States, 55422
Metro-Minnesota CCOP
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
Saint Joseph's Hospital - Healtheast
Saint Paul, Minnesota, United States, 55102
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Saint Francis Regional Medical Center
Shakopee, Minnesota, United States, 55379
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Woodwinds Health Campus
Woodbury, Minnesota, United States, 55125
Minnesota Oncology and Hematology PA-Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
University of Missouri - Ellis Fischel
Columbia, Missouri, United States, 65212
Freeman Health System
Joplin, Missouri, United States, 64804
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Missouri Baptist Medical Center
Saint Louis, Missouri, United States, 63131
Center for Cancer Care and Research
Saint Louis, Missouri, United States, 63141
United States, Montana
Billings Clinic Cancer Center
Billings, Montana, United States, 59107
Frontier Cancer Center and Blood Institute-Billings
Billings, Montana, United States, 59102
Montana Cancer Consortium CCOP
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
Saint Vincent Healthcare
Billings, Montana, United States, 59101
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States, 59701
Berdeaux, Donald MD (UIA Investigator)
Great Falls, Montana, United States, 59405
Great Falls Clinic
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital
Helena, Montana, United States, 59601
Glacier Oncology PLLC
Kalispell, Montana, United States, 59901
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Saint Patrick Hospital - Community Hospital
Missoula, Montana, United States, 59802
Guardian Oncology and Center for Wellness
Missoula, Montana, United States, 59804
Montana Cancer Specialists
Missoula, Montana, United States, 59802
Community Medical Hospital
Missoula, Montana, United States, 59801
United States, New Hampshire
New Hampshire Oncology-Hematology PA
Concord, New Hampshire, United States, 03301
New Hampshire Oncology Hematology Associates
Hooksett, New Hampshire, United States, 03106
LRGHealthcare-Lakes Region General Hospital
Laconia, New Hampshire, United States, 03246
United States, New Jersey
Cooper Hospital University Medical Center
Camden, New Jersey, United States, 08103
Saint Barnabas Medical Center
Livingston, New Jersey, United States, 07039
Inspira Medical Center Vineland
Vineland, New Jersey, United States, 08360
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
Mission Hospital-Memorial Campus
Asheville, North Carolina, United States, 28801
Duke University Medical Center
Durham, North Carolina, United States, 27710
Gaston Memorial Hospital
Gastonia, North Carolina, United States, 28054
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Southeastern Medical Oncology Center-Goldsboro
Goldsboro, North Carolina, United States, 27534
Maria Parham Hospital
Henderson, North Carolina, United States, 27536
Margaret R Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Kinston Medical Specialists PA
Kinston, North Carolina, United States, 28501
Southeastern Regional Medical Center
Lumberton, North Carolina, United States, 28358
Granville Medical Center
Oxford, North Carolina, United States, 27565
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst, North Carolina, United States, 28374
Duke Raleigh Hospital
Raleigh, North Carolina, United States, 27609
Person Memorial Hospital
Roxboro, North Carolina, United States, 27573
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, North Dakota
Bismarck Cancer Center
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
Saint Alexius Medical Center
Bismarck, North Dakota, United States, 58501
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Altru Cancer Center
Grand Forks, North Dakota, United States, 58201
Trinity Cancer Care Center
Minot, North Dakota, United States, 58701
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Samaritan North Health Center
Dayton, Ohio, United States, 45415
Clinton Memorial Hospital
Wilmington, Ohio, United States, 45177
Wright-Patterson Medical Center
Wright-Patterson Afb, Ohio, United States, 45433-5529
United States, Pennsylvania
Saint Luke's University Hospital-Bethlehem Campus
Bethlehem, Pennsylvania, United States, 18015
United States, South Carolina
Greenville Health System Cancer Institute-Eastside
Greenville, South Carolina, United States, 29615
United States, South Dakota
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
United States, Tennessee
University of Tennessee - Knoxville
Knoxville, Tennessee, United States, 37920
United States, Utah
American Fork Hospital
American Fork, Utah, United States, 84003
Sandra L Maxwell Cancer Center
Cedar City, Utah, United States, 84720
Logan Regional Hospital
Logan, Utah, United States, 84321
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
Intermountain Medical Center
Murray, Utah, United States, 84157
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center
Provo, Utah, United States, 84604
Dixie Medical Center Regional Cancer Center
Saint George, Utah, United States, 84770
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Intermountain Health Care
Salt Lake City, Utah, United States, 84103
LDS Hospital
Salt Lake City, Utah, United States, 84143
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, United States, 84106
United States, Vermont
Central Vermont Medical Center/National Life Cancer Treatment
Berlin, Vermont, United States, 05602
University of Vermont College of Medicine
Burlington, Vermont, United States, 05405
United States, Washington
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, United States, 98225
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton, Washington, United States, 98310
Kadlec Clinic Hematology and Oncology
Kennewick, Washington, United States, 99336
Skagit Valley Hospital
Mount Vernon, Washington, United States, 98274
Group Health Cooperative-Seattle
Seattle, Washington, United States, 98112
Minor and James Medical PLLC
Seattle, Washington, United States, 98104
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
The Polyclinic
Seattle, Washington, United States, 98122
University of Washington Medical Center
Seattle, Washington, United States, 98195
Cancer Care Northwest - Spokane South
Spokane, Washington, United States, 99202
Evergreen Hematology and Oncology PS
Spokane, Washington, United States, 99218
Wenatchee Valley Medical Center
Wenatchee, Washington, United States, 98801
United States, Wisconsin
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Mercy Health System
Janesville, Wisconsin, United States, 53547
Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
Dean Hematology and Oncology Clinic
Madison, Wisconsin, United States, 53717
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Green Bay Oncology - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Green Bay Oncology - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
United States, Wyoming
Welch Cancer Center
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Investigators
Principal Investigator: Harold Burstein Alliance for Clinical Trials in Oncology
  More Information

No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00390455     History of Changes
Other Study ID Numbers: NCI-2009-00475, NCI-2009-00475, CDR0000510452, CALGB-40302, CALGB 40302, CALGB-40302, U10CA180821, U10CA031946
Study First Received: October 18, 2006
Results First Received: June 1, 2015
Last Updated: June 1, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Breast Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Skin Diseases
Fulvestrant
Lapatinib
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on August 31, 2015