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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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Recurrent Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

Thank you

Trial Information

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


PRIMARY OBJECTIVE:

I. Compare the progression-free survival of postmenopausal women with stage III or IV
hormone receptor-positive breast cancer treated with fulvestrant with or without lapatinib
ditosylate.

SECONDARY OBJECTIVES:

I. Compare the response rate in patients treated with these regimens. II. Compare response
and stable disease rate (i.e., complete response, partial response, and stable disease > 6
months) in patients treated with these regimens.

III. Compare the duration of response in patients treated with these regimens. IV. Compare
the overall survival of patients treated with these regimens. V. Compare the quality of life
of patients treated with these regimens. VI. Compare the toxicity of these regimens in these
patients.

OUTLINE: This is a multicenter, open-label, randomized, double-blind, placebo-controlled
study. Patients are stratified according to prior tamoxifen citrate therapy (yes vs no) and
bone disease only (yes vs no). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral lapatinib ditosylate once daily 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 oral placebo once daily 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. Quality of life is assessed at baseline and then on day 1 of every 2
courses of treatment (i.e., day 1 of courses 3, 5, 7, etc.).

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


Inclusion Criteria:



- Histologically* or cytologically confirmed breast cancer, meeting 1 of the following
stage criteria:

- Stage III (locally advanced) disease not considered amenable to curative therapy

- Stage IV (primary or metastatic) disease

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by
conventional techniques or ≥ 1.0 cm by spiral CT scan

- Lytic or blastic bone metastases as only site of disease allowed

- The following are not considered measurable disease:

- Bone lesions (except as 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

- Must have received prior therapy with 1 or 2 endocrine treatments for breast cancer
in either the adjuvant or metastatic setting (not including treatment for ovarian
suppression or amenorrhea)

- Tumor must be potentially sensitive to endocrine therapy, defined as ≥ 3 months
of prior endocrine therapy without disease progression in the adjuvant or
metastatic setting

- Treatments must have been commercially-available third-generation aromatase
inhibitors (e.g., anastrozole, exemestane, or letrozole)*

- No symptomatic brain or other CNS metastases

- Previously treated brain metastases allowed provided patient is free of symptoms
AND > 3 months since prior treatment for brain metastases

- Hormone receptor status:

- Estrogen receptor- and/or progesterone receptor-positive tumor by IHC methods (≥
1% cells considered positive)

- Female

- Postmenopausal, meeting 1 of the following criteria:

- Age ≥ 60 years

- Age ≥ 45 years with an intact uterus and amenorrhea for ≥ 12 months

- History of bilateral oophorectomy

- Follicle-stimulating hormone levels within postmenopausal range

- Undergoing treatment with a gonadotropin-releasing hormone agonist for ovarian
suppression for ≥ 3 consecutive months prior to study entry, and remains on such
therapy throughout study treatment

- Life expectancy > 3 months

- ECOG performance status 0-2

- Granulocyte count ≥ 1,000/mm³

- Platelet count ≥ 100,000/mm³

- Total bilirubin ≤ 1.5 times upper limit of normal (ULN) (unless due to Gilbert's
syndrome)

- Creatinine ≤ 2.0 mg/dL

- AST and ALT ≤ 2.5 times ULN (5 times ULN for patients with liver metastases)

- INR ≤ 1.6

- LVEF normal

- Not pregnant or nursing

- Negative pregnancy test

- No pending visceral crisis

- No acquired or inherited bleeding disorder

- No other concurrent endocrine therapy, including systemic hormone-replacement therapy
or intravaginal estrogen

- Prior initiation of and concurrent bisphosphonate therapy allowed

- At least 2 weeks since prior chemotherapy and recovered

- Prior chemotherapy in the adjuvant and/or neoadjuvant setting allowed

- No more than 1 prior chemotherapy regimen for stage IV breast cancer

- At least 3 weeks since prior trastuzumab (Herceptin®) and recovered

- Prior trastuzumab in the adjuvant and/or neoadjuvant setting allowed

- No prior trastuzumab for stage IV breast cancer

- No prior fulvestrant

- No prior epidermal growth factor receptor (EGFR) inhibitors (e.g., gefitinib,
erlotinib hydrochloride, lapatinib ditosylate, or cetuximab)

- No other prior or concurrent experimental EGFR inhibitors

- No other concurrent chemotherapy

- No concurrent radiotherapy, including palliative radiotherapy

- No other concurrent hormonal therapy* except for the following:

- Steroids for adrenal failure

- Hormones for nondisease-related conditions (e.g., insulin for diabetes or
synthroid for hypothyroidism)

- Intermittent dexamethasone as an antiemetic

- No concurrent therapeutic systemic anticoagulation (defined as maintaining INR > 1.6)

- Low-dose warfarin or acetylsalicylic acid (or equivalent) for maintenance of
central venous catheter patency allowed

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival (PFS)

Outcome Description:

One-sided O'Brien-Fleming boundaries will be used to stop for superiority. Futility boundaries will be based on testing the alternative hypothesis at a one-sided 0.005 alpha level, as recommended by Freidlin and Korn. Specifically, Z-score futility boundaries will be calculated as 2.576 + log(1.5)*sqrt (n/4), where n is the total number of observed events. The final analysis will use the stratified log-rank test to test for a difference between the treatment arms in PFS (one-sided alpha of 0.025) where the stratification factors are prior tamoxifen (yes/no) and bone-only disease (yes/no).

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Harold Burstein

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00475

NCT ID:

NCT00390455

Start Date:

September 2006

Completion Date:

Related Keywords:

  • Recurrent Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Roswell Park Cancer InstituteBuffalo, New York  14263
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
University of Washington Medical CenterSeattle, Washington  98195-6043
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Fairview Ridges HospitalBurnsville, Minnesota  55337
Hutchinson Area Health CareHutchinson, Minnesota  55350
Meeker County Memorial HospitalLichfield, Minnesota  55355
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Loyola University Medical CenterMaywood, Illinois  60153
Rapid City Regional HospitalRapid City, South Dakota  57709
Glendale Memorial Hospital and Health CenterGlendale, California  91204
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Memorial Hospital of South BendSouth Bend, Indiana  46601
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Akron General Medical CenterAkron, Ohio  44302
LDS HospitalSalt Lake City, Utah  84143
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Virginia Piper Cancer InstituteMinneapolis, Minnesota  55407
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Eastern Maine Medical CenterBangor, Maine  04401
William Beaumont HospitalRoyal Oak, Michigan  48073
Saint Anthony Medical CenterRockford, Illinois  61108
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Group Health CooperativeSeattle, Washington  98112
Great Falls ClinicGreat Falls, Montana  59405
Trinity Cancer Care CenterMinot, North Dakota  58701
Sibley Memorial HospitalWashington, District of Columbia  20016
Holland Community HospitalHolland, Michigan  49423
Munson Medical CenterTraverse City, Michigan  49684
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Welch Cancer CenterSheridan, Wyoming  82801
Brigham and Women's HospitalBoston, Massachusetts  02115
Mercy Health SystemJanesville, Wisconsin  53545
Elkhart General HospitalElkhart, Indiana  46515
Saint Rose HospitalHayward, California  94545
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Beebe Medical CenterLewes, Delaware  19958
Memorial HospitalCarthage, Illinois  62321
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Proctor HospitalPeoria, Illinois  61614
Perry Memorial HospitalPrinceton, Illinois  61356
Valley Cancer CenterSpring Valley, Illinois  61362
Genesis Medical Center - West CampusDavenport, Iowa  52804
Mecosta County Medical CenterBig Rapids, Michigan  49307
Bismarck Cancer CenterBismarck, North Dakota  58501
Mountainview MedicalBerlin, Vermont  05602
Eureka HospitalEureka, Illinois  61530
Mercy HospitalCoon Rapids, Minnesota  55433
Graham Hospital AssociationCanton, Illinois  61520
Saint Joseph Medical CenterJoliet, Illinois  60435
Pekin HospitalPekin, Illinois  61554
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
Fairview-Southdale HospitalEdina, Minnesota  55435
Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Regions HospitalSaint Paul, Minnesota  55101
Saint Francis Regional Medical CenterShakopee, Minnesota  55379
Rice Memorial HospitalWillmar, Minnesota  56201
Altru Cancer CenterGrand Forks, North Dakota  58206
Highland General HospitalOakland, California  94602
Missouri Cancer AssociatesColumbia, Missouri  65201
Center for Cancer Care and ResearchSt. Louis, Missouri  63141
Hospital District Sixth of Harper CountyAnthony, Kansas  67003
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Clinton Memorial HospitalWilmington, Ohio  45177
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Baton Rouge General Medical CenterBaton Rouge, Louisiana  70821-2511
Greater Baltimore Medical CenterBaltimore, Maryland  21204
Lowell General HospitalLowell, Massachusetts  01854
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Memorial Medical CenterSpringfield, Illinois  62781
Southeastern Medical Oncology CenterGoldsboro, North Carolina  27534
Metro Health HospitalGrand Rapids, Michigan  49506
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Woodwinds Health CampusWoodbury, Minnesota  55125
Duke University Medical CenterDurham, North Carolina  27710
East Bay Radiation Oncology CenterCastro Valley, California  94546
Larry G Strieff MD Medical CorporationOakland, California  94609
Tahoe Forest Cancer CenterTruckee, California  96161
Hennepin County Medical CenterMinneapolis, Minnesota  
El Camino HospitalMountain View, California  94040
Case Western Reserve UniversityCleveland, Ohio  44106
Yale UniversityNew Haven, Connecticut  06520
New Hampshire Oncology-Hematology PAHooksett, New Hampshire  03106
Mid Dakota ClinicBismarck, North Dakota  58501
University Of VermontBurlington,, Vermont  05403
Kaiser PermanenteSacramento, California  
Montana Cancer Consortium CCOPBillings, Montana  59101
Huntsman Cancer Institute/University of UtahSalt Lake City, Utah  84112
Southeastern Regional Medical CenterLumberton, North Carolina  28359
Granville Medical CenterOxford, North Carolina  27565
Person Memorial HospitalRoxboro, North Carolina  27573
Metro-Minnesota CCOPSt. Louis Park, Minnesota  
UC Davis Comprehensive Cancer CenterSacramento, California  95817
Decatur Memorial HospitalDecatur, Illinois  62526
Louisiana State University Health Science CenterNew Orleans, Louisiana  70112
Frederick Memorial HospitalFrederick, Maryland  21701
Montana Cancer SpecialistsMissoula, Montana  59807-7877
University of Chicago Comprehensive Cancer CenterChicago, Illinois  60637-1470
Northern Indiana Cancer Research ConsortiumSouth Bend, Indiana  
Wake Forest University Health SciencesWinston-Salem, North Carolina  27157
OSF Saint Francis Medical CenterPeoria, Illinois  61637
Valley Medical Oncology Consultants-Castro ValleyCastro Valley, California  94546
Eden Hospital Medical CenterCastro Valley, California  94546
Northbay Cancer CenterFairfield, California  94533
Valley Medical Oncology Consultants-FremontFremont, California  94538
Fremont - Rideout Cancer CenterMarysville, California  95901
Palo Alto Medical Foundation-Camino DivisionMountain View, California  94040
Bay Area Breast Surgeons IncOakland, California  94609
Bay Area Tumor Institution CCOPOakland, California  94609
Tom K Lee IncOakland, California  94609
Valley Medical Oncology ConsultantsPleasanton, California  94588
Valley Care Health System - PleasantonPleasanton, California  94588
University of California San Francisco Medical Center-Mount ZionSan Francisco, California  94115
Doctors Medical Center- JC Robinson Regional Cancer CenterSan Pablo, California  94806
Memorial Hospital Colorado SpringsColorado Springs, Colorado  80909
Lombardi Comprehensive Cancer Center at Georgetown UniversityWashington, District of Columbia  20057
Rush - Copley Medical CenterAurora, Illinois  60504
Intercommunity Cancer CenterGalesburg, Illinois  61401
Hopedale Medical Complex - HospitalHopedale, Illinois  61747
Joliet Oncology-Hematology Associates LimitedJoliet, Illinois  60435
Community Cancer Center FoundationNormal, Illinois  61761
Illinois CancerCare-Ottawa ClinicOttawa, Illinois  61350
Ottawa Regional Hospital and Healthcare CenterOttawa, Illinois  61350
Pekin Cancer Treatment CenterPekin, Illinois  61554
Illinois Oncology Research Association CCOPPeoria, Illinois  61615
Illinois CancerCare-PeoriaPeoria, Illinois  61615
Illinois Valley HospitalPeru, Illinois  61354
Saint Margaret's HospitalSpring Valley, Illinois  61362
Carle Clinic-Urbana MainUrbana, Illinois  61801
Fort Wayne Medical Oncology and Hematology Inc - State BoulevardFort Wayne, Indiana  46845
Saint Anthony Memorial Health CenterMichigan City, Indiana  46360
McFarland ClinicAmes, Iowa  50010
Hematology Oncology Associates-Quad CitiesBettendorf, Iowa  52722
Cedar Rapids Oncology AssociationCedar Rapids, Iowa  52403
Mercy HospitalCedar Rapids, Iowa  52403
Medical Oncology and Hematology Associates-West Des MoinesClive, Iowa  50325
Genesis Medical Center - East CampusDavenport, Iowa  52803
Iowa Oncology Research Association CCOPDes Moines, Iowa  50309
Mercy CapitolDes Moines, Iowa  50307
Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des MoinesDes Moines, Iowa  50309
Mercy Medical Center-Sioux CitySioux City, Iowa  51104
Saint Luke's Regional Medical CenterSioux City, Iowa  51104
Stormont-Vail Regional Health CenterTopeka, Kansas  66604
Medical Center of LouisianaNew Orleans, Louisiana  70112
Green Bay Oncology - EscanabaEscanaba, Michigan  49431
Grand Rapids Clinical Oncology ProgramGrand Rapids, Michigan  49503
Saint Mary's Health CareGrand Rapids, Michigan  49503
Spectrum Health at Butterworth CampusGrand Rapids, Michigan  49503
Green Bay Oncology - Iron MountainIron Mountain, Michigan  49801
Mid-Michigan Medical Center - MidlandMidland, Michigan  48670
Mercy Health Partners-Mercy CampusMuskegon, Michigan  49443
Mercy Health Partners-Hackley CampusMuskegon, Michigan  49442
Lakeland HospitalSt. Joseph, Michigan  49085
Miller-Dwan HospitalDuluth, Minnesota  55805
Unity HospitalFridley, Minnesota  55432
Saint John's Hospital - HealtheastMaplewood, Minnesota  55109
Minnesota Oncology Hematology PA-MaplewoodMaplewood, Minnesota  55109
North Memorial Medical Health CenterRobbinsdale, Minnesota  55422
Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, Minnesota  55416
Saint Joseph's Hospital - HealtheastSaint Paul, Minnesota  55102
Minnesota Oncology and Hematology PA-WoodburyWoodbury, Minnesota  55125
Freeman Health SystemJoplin, Missouri  64804
Missouri Baptist Medical CenterSaint Louis, Missouri  63131
Hematology-Oncology Centers of the Northern Rockies PCBillings, Montana  59101
Saint Vincent HealthcareBillings, Montana  59101
Billings ClinicBillings, Montana  59107-7000
Saint James Community Hospital and Cancer Treatment CenterButte, Montana  59701
Berdeaux, Donald MD (UIA Investigator)Great Falls, Montana  59405
Saint Peter's Community HospitalHelena, Montana  59601
Glacier Oncology PLLCKalispell, Montana  59901
Community Medical HospitalMissoula, Montana  59801
Saint Patrick Hospital - Community HospitalMissoula, Montana  59802
New Hampshire Oncology Hematology AssociatesHooksett, New Hampshire  03106
LRGHealthcare-Lakes Region General HospitalLaconia, New Hampshire  03246
Cooper Hospital University Medical CenterCamden, New Jersey  08103
Saint Barnabas Medical CenterLivingston, New Jersey  07039
South Jersey HealthcareVineland, New Jersey  08360
State University of New York Upstate Medical UniversitySyracuse, New York  13210
Mission Hospitals IncAsheville, North Carolina  28801
Gaston Memorial HospitalGastonia, North Carolina  28054
Wayne Memorial HospitalGoldsboro, North Carolina  27534
Margaret R Pardee Memorial HospitalHendersonville, North Carolina  28791
Kinston Medical Specialists PAKinston, North Carolina  28501
Saint Alexius Medical CenterBismarck, North Dakota  58501
Samaritan North Health CenterDayton, Ohio  45415
Wright-Patterson Medical CenterWright-Patterson Afb, Ohio  45433-5529
Saint Luke's HospitalBethlehem, Pennsylvania  18015
Greenville CCOPGreenville, South Carolina  29615
Harrison Bremerton Hematology and OncologyBremerton, Washington  98310
Columbia Basin Hematology and Oncology PLLCKennewick, Washington  99336
Minor and James Medical PLLCSeattle, Washington  98104
The PolyclinicSeattle, Washington  98122
Swedish Medical Center-First HillSeattle, Washington  98122-4307
Saint Vincent HospitalGreen Bay, Wisconsin  54301
Green Bay Oncology Limited at Saint Mary's HospitalGreen Bay, Wisconsin  54303
Saint Mary's HospitalGreen Bay, Wisconsin  54303
Green Bay Oncology at Saint Vincent HospitalGreen Bay, Wisconsin  54301-3526
Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology - Sturgeon BaySturgeon Bay, Wisconsin  54235
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201
University of IllinoisChicago, Illinois  60612
York HospitalYork, Maine  03909
Elkhart ClinicElkhart, Indiana  46515
Portneuf Medical CenterPocatello, Idaho  83201
Michiana Hematology Oncology PC-South BendSouth Bend, Indiana  46601
The Memorial Hospital at EastonEaston, Maryland  21601
Memorial Hospital at Easton - Shore Regional Cancer CenterEaston, Maryland  21601
University of Michigan University HospitalAnn Arbor, Michigan  48109
University of Missouri - Ellis FischelColumbia, Missouri  65203
Maria Parham HospitalHenderson, North Carolina  27536
Duke Raleigh HospitalRaleigh, North Carolina  27609
University of Tennessee - KnoxvilleKnoxville, Tennessee  37920
Sandra L Maxwell Cancer CenterCedar City, Utah  84720
Intermountain Medical CenterMurray, Utah  84157
Utah Valley Regional Medical CenterProvo, Utah  84603
Dixie Medical Center Regional Cancer CenterSaint George, Utah  84770
Intermountain Health CareSalt Lake City, Utah  84103
Utah Cancer Specialists-Salt Lake CitySalt Lake City, Utah  84106
Skagit Valley HospitalMt. Vernon, Washington  98273
Evergreen Hematology and Oncology PSSpokane, Washington  99218
Holy Family Memorial HospitalManitowoc, Wisconsin  54221
FirstHealth of the Carolinas-Moore Regional HosiptalPinehurst, North Carolina  28374
Connecticut Oncology and Hematology LLPTorrington, Connecticut  06790
Doctors Carrol, Sheth, RaghavanLouisville, Kentucky  40215
Gundersen LutheranLa Crosse, Wisconsin  54601
Heartland Oncology and Hematology LLPCouncil Bluffs, Iowa  51503
Community Regional Cancer Care-East Radiation OncologyIndianapolis, Indiana  46219
Community Regional Cancer Care-East Medical OncologyIndianapolis, Indiana  46219
Community Regional Cancer Care-NorthIndianapolis, Indiana  46256
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Boca Raton Regional HospitalBoca Raton, Florida  33486
Carle Foundation - Carle Cancer CenterUrbana, Illinois  61801
Oncology Associates at Mercy Medical CenterCedar Rapids, Iowa  52403
Marie Yeager Cancer CenterSaint Joseph, Michigan  49085
Indiana University Health Goshen Center For Cancer CareGoshen, Indiana  46526
Essentia Health Duluth Clinic CCOPDuluth, Minnesota  55805
Essentia Health Saint Mary's Medical CenterDuluth, Minnesota  55805
Sanford Bismarck Medical CenterBismarck, North Dakota  58501
Community Howard Regional HealthKokomo, Indiana  46904
Indiana University Health La Porte HospitalLa Porte, Indiana  46350
Saint Joseph Regional Medical Center-MishawakaMishawaka, Indiana  46545-1470
Via Christi Hospital-PittsburgPittsburg, Kansas  66762
PeaceHealth Saint Joseph Medical CenterBellingham, Washington  98225
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718
Bronson Battle CreekBattle Creek, Michigan  49017