A Randomized Phase II Trial of Tamoxifen Versus Z-Endoxifen HCL in Postmenopausal Women With Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer

Who is this study for? Patients with Breast Cancer
What treatments are being studied? Laboratory Biomarker Analysis+Pharmacological Study
Status: Active, not recruiting
Location: See all (567) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This randomized phase II trial studies how well tamoxifen citrate works compared with z-endoxifen hydrochloride in treating patients with breast cancer that has spread to nearby tissue or lymph nodes or other parts of the body and has estrogen receptors but not human epidermal growth factor receptor 2 (HER2) receptors on the surface of its cells. Estrogen can cause the growth of tumor cells. Hormone therapy using tamoxifen citrate or z-endoxifen hydrochloride may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether tamoxifen citrate or z-endoxifen hydrochloride is more effective in treating patients with breast cancer.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: No
View:

• PRE-REGISTRATION ELIGIBILITY CRITERIA

• Women who agree to undergo a standard of care core biopsy of recurrent or metastatic breast cancer to confirm the ER+ (>= 10% nuclear staining) and HER2 negative status

• Patient must have been previously treated with an aromatase inhibitor (either letrozole, anastrozole or exemestane) either in the adjuvant or metastatic setting, and have one of the following types of primary or secondary endocrine resistant disease

• Primary clinical resistance is defined as one of the following:

• Recurrence within the first 2 years of adjuvant endocrine therapy while on aromatase inhibitor therapy

• Progression within first 6 months of initiating first-line endocrine therapy (either aromatase inhibitor or fulvestrant containing regimen) for the treatment of metastatic breast cancer

• Secondary clinical resistance is defined as one of the following:

• Recurrence after year 2 while receiving adjuvant aromatase inhibitor therapy, or within 12 months of completing adjuvant aromatase inhibitor therapy

• Progression occurring 6 or more months after initiating the first endocrine therapy for metastatic disease (either fulvestrant or aromatase inhibitor containing regimen)

• Patients with a history of measurable disease as defined by RECIST criteria or bone only disease are eligible; Note: those patients with non-measurable disease and bone metastases are eligible

• No history of tumors involving spinal cord or heart

• No current evidence of visceral crisis or lymphangitic spread

• No known brain metastases

• Women must be postmenopausal

• Postmenopausal status is verified by:

• Prior bilateral surgical oophorectomy, or

• Age >= 60 years, or

• Age < 60 with no menses for > 1 year with follicle-stimulating hormone (FSH) and estradiol levels within post menopausal range, according to institutional standard

• Prior treatment

• No more than two prior chemotherapy regimens in the metastatic setting

• Prior treatment with an aromatase inhibitor (either anastrozole, letrozole or exemestane), either in the adjuvant or metastatic setting is required

• Unlimited prior endocrine regimens in the metastatic setting, which may have included an everolimus or cyclin dependent kinase (CDK) 4/6 inhibitor (such as palbociclib, abemaciclib or ribociclib) containing regimen

• Prior tamoxifen treatment is allowed in the adjuvant setting, but patients must not have experienced relapse within 1 year of stopping tamoxifen

• No prior treatment with tamoxifen in the metastatic setting

• No prior treatment with endoxifen

• Patients who have not fully recovered from acute, reversible effects of prior therapy regardless of interval since last treatment are not eligible to participate in this study

• EXCEPTION: neuropathies-if grade 2 neuropathies have been stable for at least 3 months since completion of prior treatment patient is eligible

• Not receiving any medications or substances that are strong inhibitors of cytochrome P450 family 2, subfamily D, polypeptide 6 (CYP2D6)

• Not receiving any other investigational agents

• No uncontrolled intercurrent illness including, but not limited to:

• Ongoing or active infection

• Symptomatic congestive heart failure

• Unstable angina pectoris

• Uncontrolled symptomatic cardiac arrhythmia

• Uncontrolled hypertension (defined as blood pressure > 160/90)

• None of the following co-morbid conditions:

• Cataracts of grade 2 or greater as per Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

• Retinopathy of grade 2 or greater as per CTCAE version 4.0

• Note: patients that have cataracts that do not require surgery are eligible

• Note: serious adverse events will be reported on CTEP-Adverse Event Reporting System (AERS) using CTCAE version (v)5.0

• Deep vein thrombosis/pulmonary embolism (DVT/PE) within the past 6 months

• Note: patients that are on anticoagulant therapy for maintenance are eligible as long as the DVT and/or PE occurred > 6 months prior to enrollment, and there is no evidence for active thrombosis (either DVT or PE)

• No other active second malignancy other than non-melanoma skin cancers within 3 years of pre-registration; a second malignancy is not considered active if all treatment for that malignancy is completed and the patient has been disease-free for at least 3 years prior to pre-registration

• Eastern Cooperative Oncology Group (ECOG) performance status: 0-2

• Able to swallow oral formulation of the study agent

• Hemoglobin >= 9 g/dL

• Platelet count >= 75,000/mm^3

• Creatinine =< 1.5 x upper limits of normal (ULN)

• Total bilirubin =< 1.5 x upper limits of normal (ULN)

• Aspartate aminotransferase (AST) =< 2.5 x upper limits of normal (ULN); for patients with liver metastasis: =< 5 x upper limits of normal (ULN)

• REGISTRATION ELIGIBILITY CRITERIA

• Patients with either measurable disease as defined by RECIST criteria or bone only disease are eligible; Note: those patients with both non-measurable disease and bone metastases are eligible

• Non-measurable bone only disease: Non-measurable bone only disease may include any of the following: blastic bone lesions, lytic bone lesions without a measurable soft-tissue component, or mixed lytic-blastic bone lesions without a measurable soft-tissue component

• Lytic bone lesions, with an identifiable soft tissue component, evaluated by computed tomography (CT) or magnetic resonance imaging (MRI), can be considered as measurable lesions if the soft tissue component otherwise meets the definition of measurability previously described

• No tumors involving spinal cord or heart

• No visceral crisis, lymphangitic spread or known brain metastases: visceral crisis is not the mere presence of visceral metastases, but implies severe organ dysfunction as assessed by symptoms and signs, laboratory studies, and rapid progression of disease

• Histologic confirmation, from the A011203 pre-registration biopsy, by institutional/local pathologist of either locally advanced or metastatic breast cancer that is estrogen receptor positive and HER2 negative; those patients with bone only disease with either no tumor or insufficient tumor for ER/progesterone receptor (PR) and HER2 staining after the bone biopsy are still eligible to participate in this study

• Estrogen receptor positive disease is defined as > 10% nuclear staining

• HER2 negative disease as per 2013 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines, one of the following must apply:

• 0 or 1+ by immunohistochemistry (IHC) and not amplified by in situ hybridization (ISH)

• 0 or 1+ by IHC and ISH not done

• 2+ by IHC and not amplified by ISH or

• IHC not done and not amplified by ISH

• None of the following therapies are allowed prior to registration:

• Chemotherapy =< 2 weeks

• Immunotherapy =< 2 weeks

• Biologic therapy =< 2 weeks

• Hormonal therapy =< 2 weeks

• Monoclonal antibodies =< 2 weeks

• Radiation therapy =< 2 weeks

• Anti-Her-2 or other targeted (e.g. mammalian target of rapamycin [mTOR]) therapy =< 2 weeks

• NOTE : Any toxicities derived from these therapies must be =< grade 2 prior to starting study therapy

Locations
United States
Alaska
Alaska Breast Care and Surgery LLC
Anchorage
Alaska Oncology and Hematology LLC
Anchorage
Alaska Regional Hospital
Anchorage
Alaska Women's Cancer Care
Anchorage
Anchorage Associates in Radiation Medicine
Anchorage
Anchorage Oncology Centre
Anchorage
Anchorage Radiation Therapy Center
Anchorage
Katmai Oncology Group
Anchorage
Providence Alaska Medical Center
Anchorage
Fairbanks Memorial Hospital
Fairbanks
Alabama
Southern Cancer Center PC-Providence
Mobile
Arkansas
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
Jonesboro
Arizona
Mayo Clinic Hospital in Arizona
Phoenix
Mayo Clinic in Arizona
Scottsdale
California
Kaiser Permanente-Anaheim
Anaheim
PCR Oncology
Arroyo Grande
Sutter Auburn Faith Hospital
Auburn
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield
Kaiser Permanente-Baldwin Park
Baldwin Park
Kaiser Permanente-Bellflower
Bellflower
Alta Bates Summit Medical Center-Herrick Campus
Berkeley
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank
Mills-Peninsula Medical Center
Burlingame
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park
Eden Hospital Medical Center
Castro Valley
Sutter Davis Hospital
Davis
Epic Care-Dublin
Dublin
Bay Area Breast Surgeons Inc
Emeryville
Epic Care Partners in Cancer Care
Emeryville
Kaiser Permanente-Fontana
Fontana
Kaiser Permanente - Harbor City
Harbor City
Kaiser Permanente-Irvine
Irvine
UC San Diego Moores Cancer Center
La Jolla
Kaiser Permanente Los Angeles Medical Center
Los Angeles
Kaiser Permanente West Los Angeles
Los Angeles
Contra Costa Regional Medical Center
Martinez
Fremont - Rideout Cancer Center
Marysville
Mercy UC Davis Cancer Center
Merced
Memorial Medical Center
Modesto
Palo Alto Medical Foundation-Camino Division
Mountain View
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View
Sutter Cancer Research Consortium
Novato
Alta Bates Summit Medical Center - Summit Campus
Oakland
Bay Area Tumor Institute
Oakland
Hematology and Oncology Associates-Oakland
Oakland
Palo Alto Medical Foundation Health Care
Palo Alto
Kaiser Permanente - Panorama City
Panorama City
Kaiser Permanente-Riverside
Riverside
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville
Sutter Roseville Medical Center
Roseville
Sutter Medical Center Sacramento
Sacramento
University of California Davis Comprehensive Cancer Center
Sacramento
Kaiser Permanente-San Diego Mission
San Diego
Kaiser Permanente-San Diego Zion
San Diego
California Pacific Medical Center-Pacific Campus
San Francisco
Kaiser Permanente-San Marcos
San Marcos
Palo Alto Medical Foundation-Santa Cruz
Santa Cruz
Sutter Pacific Medical Foundation
Santa Rosa
Palo Alto Medical Foundation-Sunnyvale
Sunnyvale
Gene Upshaw Memorial Tahoe Forest Cancer Center
Truckee
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville
Sutter Solano Medical Center/Cancer Center
Vallejo
Kaiser Permanente-Woodland Hills
Woodland Hills
Colorado
Penrose-Saint Francis Healthcare
Colorado Springs
Rocky Mountain Cancer Centers-Penrose
Colorado Springs
Porter Adventist Hospital
Denver
Mercy Medical Center
Durango
Southwest Oncology PC
Durango
Mountain Blue Cancer Care Center
Golden
Rocky Mountain Cancer Centers-Lakewood
Lakewood
Saint Anthony Hospital
Lakewood
Littleton Adventist Hospital
Littleton
Longmont United Hospital
Longmont
Rocky Mountain Cancer Centers-Longmont
Longmont
Parker Adventist Hospital
Parker
Rocky Mountain Cancer Centers-Parker
Parker
Rocky Mountain Cancer Centers - Pueblo
Pueblo
Saint Mary Corwin Medical Center
Pueblo
Rocky Mountain Cancer Centers-Thornton
Thornton
Connecticut
Smilow Cancer Hospital Care Center at Saint Francis
Hartford
Middlesex Hospital
Middletown
Florida
Halifax Health Medical Center-Centers for Oncology
Daytona Beach
Mayo Clinic in Florida
Jacksonville
Georgia
University Cancer and Blood Center LLC
Athens
Northside Hospital
Atlanta
Augusta University Medical Center
Augusta
Northside Hospital-Forsyth
Cumming
Dekalb Medical Center
Decatur
Hawaii
Pali Momi Medical Center
'aiea
Queen's Cancer Center - Pearlridge
'aiea
The Cancer Center of Hawaii-Pali Momi
'aiea
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu
Hawaii Cancer Care Inc-Liliha
Honolulu
Island Urology
Honolulu
Kapiolani Medical Center for Women and Children
Honolulu
Kuakini Medical Center
Honolulu
Queen's Cancer Cenrer - POB I
Honolulu
Queen's Cancer Center - Kuakini
Honolulu
Queen's Medical Center
Honolulu
Straub Clinic and Hospital
Honolulu
The Cancer Center of Hawaii-Liliha
Honolulu
University of Hawaii Cancer Center
Honolulu
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue
Iowa
Mary Greeley Medical Center
Ames
McFarland Clinic PC - Ames
Ames
McFarland Clinic PC-Boone
Boone
Medical Oncology and Hematology Associates-West Des Moines
Clive
Mercy Cancer Center-West Lakes
Clive
Alegent Health Mercy Hospital
Council Bluffs
Greater Regional Medical Center
Creston
Medical Oncology and Hematology Associates-Laurel
Des Moines
Mercy Medical Center - Des Moines
Des Moines
JCHC McCreery Cancer Center
Fairfield
McFarland Clinic PC-Trinity Cancer Center
Fort Dodge
McFarland Clinic PC-Jefferson
Jefferson
McFarland Clinic PC-Marshalltown
Marshalltown
Ottumwa Regional Health Center
Ottumwa
Mercy Medical Center-West Lakes
West Des Moines
Idaho
Saint Alphonsus Cancer Care Center-Boise
Boise
Saint Luke's Cancer Institute - Boise
Boise
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell
Kootenai Health - Coeur d'Alene
Coeur D'alene
Walter Knox Memorial Hospital
Emmett
Saint Luke's Cancer Institute - Fruitland
Fruitland
Idaho Urologic Institute-Meridian
Meridian
Saint Luke's Cancer Institute - Meridian
Meridian
Saint Alphonsus Medical Center-Nampa
Nampa
Saint Luke's Cancer Institute - Nampa
Nampa
Kootenai Clinic Cancer Services - Post Falls
Post Falls
Kootenai Cancer Clinic
Sandpoint
Saint Luke's Cancer Institute - Twin Falls
Twin Falls
Illinois
Rush - Copley Medical Center
Aurora
Illinois CancerCare-Bloomington
Bloomington
Saint Joseph Medical Center
Bloomington
Illinois CancerCare-Canton
Canton
Memorial Hospital of Carbondale
Carbondale
SIH Cancer Institute
Carterville
Illinois CancerCare-Carthage
Carthage
Centralia Oncology Clinic
Centralia
John H Stroger Jr Hospital of Cook County
Chicago
Northwestern University
Chicago
Presence Saint Joseph Hospital-Chicago
Chicago
University of Chicago Comprehensive Cancer Center
Chicago
Carle on Vermilion
Danville
Cancer Care Specialists of Illinois - Decatur
Decatur
Decatur Memorial Hospital
Decatur
Carle Physician Group-Effingham
Effingham
Crossroads Cancer Center
Effingham
AMITA Health Alexian Brothers Medical Center
Elk Grove Village
Illinois CancerCare-Eureka
Eureka
Illinois CancerCare-Galesburg
Galesburg
Western Illinois Cancer Treatment Center
Galesburg
Illinois CancerCare-Kewanee Clinic
Kewanee
Illinois CancerCare-Macomb
Macomb
Carle Physician Group-Mattoon/Charleston
Mattoon
Good Samaritan Regional Health Center
Mount Vernon
UC Comprehensive Cancer Center at Silver Cross
New Lenox
Cancer Care Center of O'Fallon
O'fallon
Illinois CancerCare-Ottawa Clinic
Ottawa
Radiation Oncology of Northern Illinois
Ottawa
Illinois CancerCare-Pekin
Pekin
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin
Illinois CancerCare-Peoria
Peoria
Methodist Medical Center of Illinois
Peoria
OSF Saint Francis Medical Center
Peoria
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria
Illinois CancerCare-Peru
Peru
Valley Radiation Oncology
Peru
Illinois CancerCare-Princeton
Princeton
Central Illinois Hematology Oncology Center
Springfield
Memorial Medical Center
Springfield
Southern Illinois University School of Medicine
Springfield
Springfield Clinic
Springfield
Southwest Illinois Health Services LLP
Swansea
Carle Cancer Center
Urbana
The Carle Foundation Hospital
Urbana
Rush-Copley Healthcare Center
Yorkville
Indiana
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis
Sidney and Lois Eskenazi Hospital
Indianapolis
Springmill Medical Center
Indianapolis
Franciscan Saint Anthony Health-Michigan City
Michigan City
Woodland Cancer Care Center
Michigan City
Memorial Regional Cancer Center Day Road
Mishawaka
Reid Health
Richmond
Memorial Hospital of South Bend
South Bend
Kansas
Cancer Center of Kansas - Chanute
Chanute
Cancer Center of Kansas - Dodge City
Dodge City
Cancer Center of Kansas - El Dorado
El Dorado
Cancer Center of Kansas - Fort Scott
Fort Scott
Cancer Center of Kansas-Independence
Independence
Cancer Center of Kansas-Kingman
Kingman
Lawrence Memorial Hospital
Lawrence
Cancer Center of Kansas-Liberal
Liberal
Cancer Center of Kansas-Manhattan
Manhattan
Cancer Center of Kansas - McPherson
Mcpherson
Cancer Center of Kansas - Newton
Newton
Cancer Center of Kansas - Parsons
Parsons
Cancer Center of Kansas - Pratt
Pratt
Cancer Center of Kansas - Salina
Salina
Cancer Center of Kansas - Wellington
Wellington
Ascension Via Christi Hospitals Wichita
Wichita
Associates In Womens Health
Wichita
Cancer Center of Kansas - Wichita
Wichita
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita
Wichita NCI Community Oncology Research Program
Wichita
Cancer Center of Kansas - Winfield
Winfield
Kentucky
Flaget Memorial Hospital
Bardstown
Baptist Health Corbin
Corbin
Commonwealth Cancer Center-Corbin
Corbin
Oncology Hematology Care Inc-Crestview
Crestview Hills
Baptist Health Hardin
Elizabethtown
Baptist Health Lexington
Lexington
Saint Joseph Hospital East
Lexington
Saint Joseph Radiation Oncology Resource Center
Lexington
Baptist Health Louisville
Louisville
Jewish Hospital
Louisville
Jewish Hospital Medical Center Northeast
Louisville
Saints Mary and Elizabeth Hospital
Louisville
Baptist Health Madisonville/Merle Mahr Cancer Center
Madisonville
Baptist Health Paducah
Paducah
Jewish Hospital Medical Center South
Shepherdsville
Louisiana
Ochsner Health Center-Summa
Baton Rouge
Ochsner Medical Center Kenner
Kenner
Ochsner Medical Center Jefferson
New Orleans
Maryland
Christiana Care - Union Hospital
Elkton
Maine
Harold Alfond Center for Cancer Care
Augusta
Eastern Maine Medical Center
Bangor
Lafayette Family Cancer Center-EMMC
Brewer
Michigan
Saint Joseph Mercy Hospital
Ann Arbor
Bronson Battle Creek
Battle Creek
IHA Hematology Oncology Consultants-Brighton
Brighton
Saint Joseph Mercy Brighton
Brighton
IHA Hematology Oncology Consultants-Canton
Canton
Saint Joseph Mercy Canton
Canton
Caro Cancer Center
Caro
IHA Hematology Oncology Consultants-Chelsea
Chelsea
Saint Joseph Mercy Chelsea
Chelsea
Hematology Oncology Consultants-Clarkston
Clarkston
Newland Medical Associates-Clarkston
Clarkston
Beaumont Hospital - Dearborn
Dearborn
Ascension Saint John Hospital
Detroit
Great Lakes Cancer Management Specialists-Doctors Park
East China Township
Genesee Cancer and Blood Disease Treatment Center
Flint
Genesee Hematology Oncology PC
Flint
Genesys Hurley Cancer Institute
Flint
Hurley Medical Center
Flint
Mercy Health Saint Mary's
Grand Rapids
Spectrum Health at Butterworth Campus
Grand Rapids
Academic Hematology Oncology Specialists
Grosse Pointe Woods
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods
Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods
Allegiance Health
Jackson
Borgess Medical Center
Kalamazoo
West Michigan Cancer Center
Kalamazoo
Sparrow Hospital
Lansing
Hope Cancer Clinic
Livonia
Saint Mary Mercy Hospital
Livonia
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb
Michigan Breast Specialists-Macomb Township
Macomb
Saint Mary's Oncology/Hematology Associates of Marlette
Marlette
Mid-Michigan Medical Center - Midland
Midland
Monroe Cancer Center
Monroe
Mercy Health Mercy Campus
Muskegon
Lakeland Hospital Niles
Niles
21st Century Oncology-Pontiac
Pontiac
Hope Cancer Center
Pontiac
Newland Medical Associates-Pontiac
Pontiac
Saint Joseph Mercy Oakland
Pontiac
Lake Huron Medical Center
Port Huron
Spectrum Health Reed City Hospital
Reed City
Great Lakes Cancer Management Specialists-Rochester Hills
Rochester Hills
Ascension Saint Mary's Hospital
Saginaw
Oncology Hematology Associates of Saginaw Valley PC
Saginaw
Lakeland Medical Center Saint Joseph
Saint Joseph
Marie Yeager Cancer Center
Saint Joseph
Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights
Munson Medical Center
Traverse City
Advanced Breast Care Center PLLC
Warren
Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren
Macomb Hematology Oncology PC
Warren
Michigan Breast Specialists-Warren
Warren
Saint John Macomb-Oakland Hospital
Warren
Saint Mary's Oncology/Hematology Associates of West Branch
West Branch
Metro Health Hospital
Wyoming
Huron Gastroenterology PC
Ypsilanti
IHA Hematology Oncology Consultants-Ann Arbor
Ypsilanti
Minnesota
Sanford Joe Lueken Cancer Center
Bemidji
Essentia Health Saint Joseph's Medical Center
Brainerd
Essentia Health Cancer Center
Duluth
Essentia Health Saint Mary's Medical Center
Duluth
Miller-Dwan Hospital
Duluth
Lake Region Healthcare Corporation-Cancer Care
Fergus Falls
Mayo Clinic in Rochester
Rochester
Coborn Cancer Center at Saint Cloud Hospital
Saint Cloud
Missouri
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin
Central Care Cancer Center - Bolivar
Bolivar
Parkland Health Center-Bonne Terre
Bonne Terre
Cox Cancer Center Branson
Branson
Saint Francis Medical Center
Cape Girardeau
Southeast Cancer Center
Cape Girardeau
University of Missouri - Ellis Fischel
Columbia
Siteman Cancer Center at West County Hospital
Creve Coeur
Capital Region Southwest Campus
Jefferson City
Freeman Health System
Joplin
Mercy Hospital Joplin
Joplin
Delbert Day Cancer Institute at PCRMC
Rolla
Mercy Clinic-Rolla-Cancer and Hematology
Rolla
Mercy Hospital Saint Louis
Saint Louis
Missouri Baptist Medical Center
Saint Louis
Saint Louis Cancer and Breast Institute-South City
Saint Louis
Washington University School of Medicine
Saint Louis
Siteman Cancer Center at Saint Peters Hospital
Saint Peters
Sainte Genevieve County Memorial Hospital
Sainte Genevieve
CoxHealth South Hospital
Springfield
Mercy Hospital Springfield
Springfield
Missouri Baptist Sullivan Hospital
Sullivan
Missouri Baptist Outpatient Center-Sunset Hills
Sunset Hills
Mississippi
University of Mississippi Medical Center
Jackson
Singing River Hospital
Pascagoula
Montana
Community Hospital of Anaconda
Anaconda
Billings Clinic Cancer Center
Billings
Saint Vincent Healthcare
Billings
Bozeman Deaconess Hospital
Bozeman
Saint James Community Hospital and Cancer Treatment Center
Butte
Benefis Healthcare- Sletten Cancer Institute
Great Falls
Great Falls Clinic
Great Falls
Saint Peter's Community Hospital
Helena
Kalispell Regional Medical Center
Kalispell
Community Medical Hospital
Missoula
Saint Patrick Hospital - Community Hospital
Missoula
North Carolina
AdventHealth Infusion Center Asheville
Asheville
Gaston Hematology and Oncology Associates-Belmont
Belmont
Waverly Hematology Oncology
Cary
UNC Lineberger Comprehensive Cancer Center
Chapel Hill
Sampson Radiation Oncology
Clinton
Southeastern Medical Oncology Center-Clinton
Clinton
Duke University Medical Center
Durham
CaroMont Regional Medical Center
Gastonia
Gaston Hematology and Oncology Associates
Gastonia
Southeastern Medical Oncology Center-Goldsboro
Goldsboro
Wayne Memorial Hospital
Goldsboro
Wayne Radiation Oncology
Goldsboro
Maria Parham Hospital
Henderson
AdventHealth Hendersonville
Hendersonville
Hendersonville Hematology and Oncology at Pardee
Hendersonville
Margaret R Pardee Memorial Hospital
Hendersonville
Onslow Memorial Hospital
Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Jacksonville
Vidant Oncology-Kinston
Kinston
Scotland Memorial Hospital-Laurinburg Cancer Center
Laurinburg
Southeastern Regional Medical Center
Lumberton
Cleveland Hematology and Oncology Associates PC
Shelby
Johnston Memorial Hospital
Smithfield
Wake Forest University Health Sciences
Winston-salem
North Dakota
Sanford Bismarck Medical Center
Bismarck
Essentia Health Cancer Center-South University Clinic
Fargo
Sanford Broadway Medical Center
Fargo
Sanford Clinic North-Fargo
Fargo
Sanford Roger Maris Cancer Center
Fargo
Altru Cancer Center
Grand Forks
Nebraska
CHI Health Saint Francis
Grand Island
CHI Health Good Samaritan
Kearney
Heartland Hematology and Oncology
Kearney
Saint Elizabeth Regional Medical Center
Lincoln
Alegent Health Bergan Mercy Medical Center
Omaha
Alegent Health Immanuel Medical Center
Omaha
Alegent Health Lakeside Hospital
Omaha
Creighton University Medical Center
Omaha
Hematology and Oncology Consultants PC
Omaha
University of Nebraska Medical Center
Omaha
Midlands Community Hospital
Papillion
New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon
Norris Cotton Cancer Center-Manchester
Manchester
Norris Cotton Cancer Center-Nashua
Nashua
New Mexico
University of New Mexico Cancer Center
Albuquerque
Nevada
Carson Tahoe Regional Medical Center
Carson City
21st Century Oncology-Henderson
Henderson
Cancer and Blood Specialists-Henderson
Henderson
Comprehensive Cancer Centers of Nevada - Henderson
Henderson
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson
Las Vegas Cancer Center-Henderson
Henderson
21st Century Oncology
Las Vegas
21st Century Oncology-Fort Apache
Las Vegas
21st Century Oncology-Vegas Tenaya
Las Vegas
Ann M Wierman MD LTD
Las Vegas
Cancer and Blood Specialists-Shadow
Las Vegas
Cancer and Blood Specialists-Tenaya
Las Vegas
Cancer Therapy and Integrative Medicine
Las Vegas
Comprehensive Cancer Centers of Nevada
Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas
Las Vegas Cancer Center-Medical Center
Las Vegas
OptumCare Cancer Care at Fort Apache
Las Vegas
Radiation Oncology Centers of Nevada Central
Las Vegas
Radiation Oncology Centers of Nevada Southeast
Las Vegas
Summerlin Hospital Medical Center
Las Vegas
Renown Regional Medical Center
Reno
Saint Mary's Regional Medical Center
Reno
New York
State University of New York Downstate Medical Center
Brooklyn
Northwell Health/Center for Advanced Medicine
Lake Success
Ohio
Cleveland Clinic Akron General
Akron
Strecker Cancer Center-Belpre
Belpre
Aultman Health Foundation
Canton
Cleveland Clinic Mercy Hospital
Canton
Dayton Physicians LLC-Miami Valley South
Centerville
Miami Valley Hospital South
Centerville
Adena Regional Medical Center
Chillicothe
Bethesda North Hospital
Cincinnati
Good Samaritan Hospital - Cincinnati
Cincinnati
Oncology Hematology Care Inc-Anderson
Cincinnati
Oncology Hematology Care Inc-Blue Ash
Cincinnati
Oncology Hematology Care Inc-Eden Park
Cincinnati
Oncology Hematology Care Inc-Kenwood
Cincinnati
Oncology Hematology Care Inc-Mercy West
Cincinnati
TriHealth Cancer Institute-Anderson
Cincinnati
TriHealth Cancer Institute-Westside
Cincinnati
Columbus Oncology and Hematology Associates Inc
Columbus
Doctors Hospital
Columbus
Grant Medical Center
Columbus
Mount Carmel East Hospital
Columbus
Mount Carmel Health Center West
Columbus
Ohio State University Comprehensive Cancer Center
Columbus
Riverside Methodist Hospital
Columbus
The Mark H Zangmeister Center
Columbus
Dayton Physician LLC-Miami Valley Hospital North
Dayton
Good Samaritan Hospital - Dayton
Dayton
Miami Valley Hospital
Dayton
Miami Valley Hospital North
Dayton
Delaware Health Center-Grady Cancer Center
Delaware
Delaware Radiation Oncology
Delaware
Grady Memorial Hospital
Delaware
Oncology Hematology Care Inc-Healthplex
Fairfield
Armes Family Cancer Center
Findlay
Blanchard Valley Hospital
Findlay
Orion Cancer Care
Findlay
Atrium Medical Center-Middletown Regional Hospital
Franklin
Dayton Physicians LLC-Atrium
Franklin
Dayton Physicians LLC-Wayne
Greenville
Wayne Hospital
Greenville
First Dayton Cancer Care
Kettering
Greater Dayton Cancer Center
Kettering
Kettering Medical Center
Kettering
Fairfield Medical Center
Lancaster
OhioHealth Mansfield Hospital
Mansfield
Marietta Memorial Hospital
Marietta
OhioHealth Marion General Hospital
Marion
Dayton Physicians LLC-Signal Point
Middletown
Knox Community Hospital
Mount Vernon
Licking Memorial Hospital
Newark
Newark Radiation Oncology
Newark
Southern Ohio Medical Center
Portsmouth
Dayton Physicians LLC-Wilson
Sidney
Springfield Regional Cancer Center
Springfield
Springfield Regional Medical Center
Springfield
ProMedica Flower Hospital
Sylvania
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
Toledo
Dayton Physicians LLC-Upper Valley
Troy
Upper Valley Medical Center
Troy
Saint Ann's Hospital
Westerville
Genesis Healthcare System Cancer Care Center
Zanesville
Oklahoma
Cancer Centers of Southwest Oklahoma Research
Lawton
University of Oklahoma Health Sciences Center
Oklahoma City
Oregon
Saint Alphonsus Medical Center-Baker City
Baker City
Saint Charles Health System
Bend
Clackamas Radiation Oncology Center
Clackamas
Providence Cancer Institute Clackamas Clinic
Clackamas
Bay Area Hospital
Coos Bay
Providence Newberg Medical Center
Newberg
Saint Alphonsus Medical Center-Ontario
Ontario
Providence Willamette Falls Medical Center
Oregon City
Providence Portland Medical Center
Portland
Providence Saint Vincent Medical Center
Portland
Pennsylvania
Abington Memorial Hospital
Abington
Lehigh Valley Hospital-Cedar Crest
Allentown
Lehigh Valley Hospital - Muhlenberg
Bethlehem
Geisinger Medical Center
Danville
Doylestown Hospital
Doylestown
Geisinger Medical Center-Cancer Center Hazleton
Hazleton
Geisinger Medical Oncology-Lewisburg
Lewisburg
Lewistown Hospital
Lewistown
Geisinger Cancer Services-Pottsville
Pottsville
Community Medical Center
Scranton
Geisinger Medical Oncology-Selinsgrove
Selinsgrove
Geisinger Medical Group
State College
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-barre
South Carolina
Bon Secours Saint Francis Hospital
Charleston
Charleston Oncology - Roper
Charleston
Charleston Oncology - Saint Francis
Charleston
Lowcountry Hematology Oncology PA-North Charleston
Charleston
Lowcountry Hematology Oncology PA-West Ashley
Charleston
Roper Hospital
Charleston
Saint Francis Cancer Center
Greenville
Saint Francis Hospital
Greenville
Self Regional Healthcare
Greenwood
Lowcountry Hematology Oncology PA-Mount Pleasant
Mount Pleasant
South Dakota
Sanford Cancer Center Oncology Clinic
Sioux Falls
Sanford USD Medical Center - Sioux Falls
Sioux Falls
Tennessee
Memorial Hospital
Chattanooga
Pulmonary Medicine Center of Chattanooga-Hixson
Hixson
Memorial GYN Plus
Ooltewah
Texas
Saint Joseph Regional Cancer Center
Bryan
Virginia
Bon Secours Memorial Regional Medical Center
Mechanicsville
Bon Secours Saint Francis Medical Center
Midlothian
Bon Secours Saint Mary's Hospital
Richmond
Washington
Providence Regional Cancer System-Aberdeen
Aberdeen
Cancer Care Center at Island Hospital
Anacortes
MultiCare Auburn Medical Center
Auburn
Virginia Mason Bainbridge Island Medical Center
Bainbridge Island
Overlake Medical Center
Bellevue
Swedish Cancer Institute-Eastside Oncology Hematology
Bellevue
PeaceHealth Saint Joseph Medical Center
Bellingham
Harrison HealthPartners Hematology and Oncology-Bremerton
Bremerton
Harrison Medical Center
Bremerton
Highline Medical Center-Main Campus
Burien
Providence Regional Cancer System-Centralia
Centralia
Swedish Cancer Institute-Edmonds
Edmonds
Saint Elizabeth Hospital
Enumclaw
Providence Regional Cancer Partnership
Everett
Saint Francis Hospital
Federal Way
Virginia Mason Federal Way Medical Center
Federal Way
MultiCare Gig Harbor Medical Park
Gig Harbor
Tacoma/Valley Radiation Oncology Centers-Gig Harbor
Gig Harbor
Swedish Cancer Institute-Issaquah
Issaquah
Providence Regional Cancer System-Lacey
Lacey
Saint Clare Hospital
Lakewood
PeaceHealth Saint John Medical Center
Longview
Virginia Mason Lynnwood Medical Center
Lynnwood
Jefferson Healthcare
Port Townsend
Harrison HealthPartners Hematology and Oncology-Poulsbo
Poulsbo
Peninsula Cancer Center
Poulsbo
MultiCare Good Samaritan Hospital
Puyallup
Tacoma/Valley Radiation Oncology Centers-Puyallup
Puyallup
Kaiser Permanente Washington
Seattle
Minor and James Medical PLLC
Seattle
Pacific Gynecology Specialists
Seattle
Swedish Medical Center-Ballard Campus
Seattle
Swedish Medical Center-First Hill
Seattle
Virginia Mason Medical Center
Seattle
Providence Regional Cancer System-Shelton
Shelton
Evergreen Hematology and Oncology PS
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - North
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Spokane Valley
Franciscan Research Center-Northwest Medical Plaza
Tacoma
MultiCare Tacoma General Hospital
Tacoma
Northwest Medical Specialties PLLC
Tacoma
Northwest NCI Community Oncology Research Program
Tacoma
Tacoma/Valley Radiation Oncology Centers-Jackson Hall
Tacoma
Tacoma/Valley Radiation Oncology Centers-Saint Joe's
Tacoma
PeaceHealth Southwest Medical Center
Vancouver
Providence Saint Mary Regional Cancer Center
Walla Walla
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima
Providence Regional Cancer System-Yelm
Yelm
Wisconsin
Ascension Columbia Saint Mary's Hospital Ozaukee
Mequon
Ascension Columbia Saint Mary's Hospital - Milwaukee
Milwaukee
Medical College of Wisconsin
Milwaukee
Aspirus Cancer Care - Wisconsin Rapids
Wisconsin Rapids
Wyoming
Big Horn Basin Cancer Center
Cody
Billings Clinic-Cody
Cody
Welch Cancer Center
Sheridan
Time Frame
Start Date: March 6, 2015
Estimated Completion Date: May 25, 2022
Participants
Target number of participants: 81
Treatments
Experimental: Arm I (z-endoxifen hydrochloride)
Patients receive z-endoxifen hydrochloride PO on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Experimental: Arm II (tamoxifen citrate)
Patients receive tamoxifen citrate PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression and bone metastases may cross over to Arm I and receive z-endoxifen hydrochloride starting no later than 28 days after documentation of disease progression.
Sponsors
Leads: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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