Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer
A Phase II Prospective Trial Correlating Progression Free Survival With CYP2D6 Activity in Patients With Metastatic Breast Cancer Treated With Single Agent Tamoxifen
2 other identifiers
interventional
124
3 countries
294
Brief Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight cancer by blocking the use of estrogen by tumor cells. PURPOSE: This phase II trial is studying how well tamoxifen citrate works in patients with metastatic or recurrent breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jan 2011
Longer than P75 for phase_2 breast-cancer
294 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2010
CompletedFirst Posted
Study publicly available on registry
May 17, 2010
CompletedStudy Start
First participant enrolled
January 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedResults Posted
Study results publicly available
March 14, 2023
CompletedJune 29, 2023
June 1, 2023
9.9 years
May 14, 2010
September 7, 2022
June 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free Survival by CYP2D6 Status in 2 Categories
Progression-free survival is defined as the time from registration to progression or death, whichever occurs first. Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) was used to evaluate progression. Progression is defined as appearance of one or more new lesions or unequivocal progression of existing non-target lesions or at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Assessed every 3 months for 2 years, then every 6 months up to 5 years
Secondary Outcomes (5)
Progression-free Survival by CYP2D6 Status in 3 Categories
Assessed every 3 months for 2 years, then every 6 months up to 5 years
Proportion of Patients Progression-free at 6 Months
Assessed every 3 months for 6 months
Proportion of Patients With Response
Assessed every 3 months for 2 years, then every 6 months up to 5 years
Endoxifen Concentration by Response
Endoxifen was assessed at cycle 3; response was assessed every 3 months for 2 years, then every 6 months up to 5 years
Progression-free Survival From 3 Months Post Registration
Assessed every 3 months for 2 years, then every 6 months up to 5 years
Study Arms (1)
Tamoxifen
EXPERIMENTALPatients receive oral tamoxifen citrate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed adenocarcinoma of the breast
- Stage III (locally advanced), metastatic, or recurrent disease
- Deemed not resectable
- Estrogen-receptor and/or progesterone-receptor positive disease
- Receptor status is based on most recent results
- Measurable or non-measurable disease
- ECOG performance status 0-2
- History of central nervous system (CNS) metastasis allowed provided it has been treated (surgery, radiotherapy, or radiosurgery) within the past 4 weeks and does not require medications to control symptoms
- Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases present)
- Negative pregnancy test
- Fertile patients must use effective nonhormonal contraception
- Disease-free of prior invasive malignancies for ≥ 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Prior chemotherapy, trastuzumab, or bevacizumab in the adjuvant setting allowed provided it has been completed ≥ 4 weeks before study therapy; other prior non-hormonal investigational agents in the adjuvant setting must have been completed at least 4 weeks prior to study registration and should be discussed with the study PI
- Prior tamoxifen as adjuvant treatment is allowed as long as the patient did not have disease relapse or progression while on adjuvant tamoxifen or within 4 weeks of last dose
- +11 more criteria
You may not qualify if:
- Pregnant or nursing
- Concurrent chemotherapy
- Leptomeningeal disease
- Non-protocol concurrent hormonal therapy
- Medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, assessment of response, or anticipated toxicities
- Prior tamoxifen for advanced disease
- More than 2 lines of non-hormonal treatment in the locally advanced or metastatic setting, including trastuzumab (Herceptin), bevacizumab, or other biologics
- Starting bisphosphonate therapy while receiving treatment on this study
- Patients who have begun receiving bisphosphonate therapy prior to registration may continue at the same intervals used prior to study registration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ECOG-ACRIN Cancer Research Grouplead
- National Cancer Institute (NCI)collaborator
Study Sites (294)
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294, United States
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, 36604, United States
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, 72903, United States
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
Marysville, California, 95901, United States
Mercy Cancer Center at Mercy Medical Center
Merced, California, 95340, United States
Camino Medical Group - Treatment Center
Mountain View, California, 94040, United States
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, 92868, United States
Palo Alto Medical Foundation
Palo Alto, California, 94301, United States
Valley Medical Oncology Consultants - Pleasanton
Pleasanton, California, 94588, United States
University of California Davis Cancer Center
Sacramento, California, 95817, United States
Tahoe Forest Cancer Center
Truckee, California, 96161, United States
Aurora Presbyterian Hospital
Aurora, Colorado, 80012, United States
Boulder Community Hospital
Boulder, Colorado, 80301-9019, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, 80933, United States
St. Anthony Central Hospital
Denver, Colorado, 80204, United States
Porter Adventist Hospital
Denver, Colorado, 80210, United States
Presbyterian - St. Luke's Medical Center
Denver, Colorado, 80218, United States
St. Joseph Hospital
Denver, Colorado, 80218, United States
Rose Medical Center
Denver, Colorado, 80220, United States
CCOP - Colorado Cancer Research Program
Denver, Colorado, 80222, United States
Swedish Medical Center
Englewood, Colorado, 80110, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, 81502, United States
North Colorado Medical Center
Greeley, Colorado, 80631, United States
Littleton Adventist Hospital
Littleton, Colorado, 80122, United States
Sky Ridge Medical Center
Lone Tree, Colorado, 80124, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, 80501, United States
McKee Medical Center
Loveland, Colorado, 80539, United States
Parker Adventist Hospital
Parker, Colorado, 80138, United States
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, 81004, United States
North Suburban Medical Center
Thornton, Colorado, 80229, United States
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, 80033, United States
Middlesex Hospital Cancer Center
Middletown, Connecticut, 06457, United States
Yale Cancer Center
New Haven, Connecticut, 06520-8028, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark, Delaware, 19713, United States
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Washington Cancer Institute at Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Broward General Medical Center Cancer Center
Fort Lauderdale, Florida, 33316, United States
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, 31405, United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813, United States
OnCare Hawaii, Incorporated - Lusitana
Honolulu, Hawaii, 96813, United States
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, 96813, United States
Hawaii Medical Center - East
Honolulu, Hawaii, 96817, United States
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii, 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Kauai Medical Clinic
Lihue, Hawaii, 96766, United States
Maui Memorial Medical Center
Wailuku, Hawaii, 96793, United States
Pacific Cancer Institute - Maui
Wailuku, Hawaii, 96793, United States
Kapiolani Medical Center at Pali Momi
‘Aiea, Hawaii, 96701, United States
Louis A. Weiss Memorial Hospital
Chicago, Illinois, 60640, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526, United States
Elmhurst Memorial Hospital
Elmhurst, Illinois, 60126, United States
La Grange Memorial Hospital
La Grange, Illinois, 60525, United States
West Suburban Center for Cancer Care
River Forest, Illinois, 60305, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, 46107, United States
Elkhart Clinic, LLC
Elkhart, Indiana, 46514-2098, United States
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, 46514, United States
Elkhart General Hospital
Elkhart, Indiana, 46515, United States
William N. Wishard Memorial Hospital
Indianapolis, Indiana, 46202, United States
Howard Community Hospital
Kokomo, Indiana, 46904, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350, United States
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, 46545-1470, United States
Saint Joseph Regional Medical Center
Mishawaka, Indiana, 46545-1470, United States
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, 47303-3499, United States
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, 46563, United States
Reid Hospital & Health Care Services
Richmond, Indiana, 47374, United States
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, 46391, United States
McFarland Clinic, PC
Ames, Iowa, 50010, United States
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, 50325, United States
Mercy Cancer Center - West Lakes
Clive, Iowa, 50325, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City, Iowa, 51102, United States
St. Luke's Regional Medical Center
Sioux City, Iowa, 51104, United States
Methodist West Hospital
West Des Moines, Iowa, 50266-7700, United States
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence, Kansas, 67301, United States
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence, Kansas, 66044, United States
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, 67901, United States
Cancer Center of Kansas, PA - McPherson
McPherson, Kansas, 67460, United States
Cancer Center of Kansas, PA - Newton
Newton, Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina, Kansas, 67401, United States
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, 67214, United States
CCOP - Wichita
Wichita, Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, 67156, United States
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410, United States
Union Hospital of Cecil County
Elkton, Maryland, 21921, United States
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, 49221, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0942, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379, United States
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202, United States
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, 49431, United States
Dickinson County Healthcare System
Iron Mountain, Michigan, 49801, United States
Borgess Medical Center
Kalamazoo, Michigan, 49001, United States
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731, United States
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007, United States
Community Cancer Center of Monroe
Monroe, Michigan, 48162, United States
Mercy Memorial Hospital - Monroe
Monroe, Michigan, 48162, United States
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085, United States
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, 49085, United States
MeritCare Bemidji
Bemidji, Minnesota, 56601, United States
St. Joseph's Medical Center
Brainerd, Minnesota, 56401, United States
Fairview Ridges Hospital
Burnsville, Minnesota, 55337, United States
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, 55433, United States
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, 55805-1983, United States
CCOP - Duluth
Duluth, Minnesota, 55805, United States
Miller - Dwan Medical Center
Duluth, Minnesota, 55805, United States
Fairview Southdale Hospital
Edina, Minnesota, 55435, United States
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350, United States
Immanuel St. Joseph's
Mankato, Minnesota, 56002, United States
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, 55109, United States
Minnesota Oncology - Maplewood
Maplewood, Minnesota, 55109, United States
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415, United States
New Ulm Medical Center
New Ulm, Minnesota, 56073, United States
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, 55422-2900, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416, United States
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, 55416, United States
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, 55101, United States
United Hospital
Saint Paul, Minnesota, 55102, United States
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, 55379, United States
Lakeview Hospital
Stillwater, Minnesota, 55082, United States
Ridgeview Medical Center
Waconia, Minnesota, 55387, United States
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, 56201, United States
Minnesota Oncology - Woodbury
Woodbury, Minnesota, 55125, United States
University of Mississippi Cancer Clinic
Jackson, Mississippi, 39216, United States
Central Care Cancer Center at Carrie J. Babb Cancer Center
Bolivar, Missouri, 65613, United States
Skaggs Cancer Center at Skaggs Regional Medical Center
Branson, Missouri, 65616, United States
Southeast Cancer Center
Cape Girardeau, Missouri, 63703, United States
Goldschmidt Cancer Center
Jefferson City, Missouri, 65109, United States
Mercy Clinic Cancer and Hematology - Rolla
Rolla, Missouri, 65401, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, 65802, United States
St. John's Regional Health Center
Springfield, Missouri, 65804, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807, United States
Missouri Baptist Cancer Center
St Louis, Missouri, 63131, United States
CCOP - Montana Cancer Consortium
Billings, Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings, Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59102, United States
Billings Clinic - Downtown
Billings, Montana, 59107-7000, United States
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715, United States
St. James Healthcare Cancer Care
Butte, Montana, 59701, United States
Big Sky Oncology
Great Falls, Montana, 59405-5309, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, 59405, United States
St. Peter's Hospital
Helena, Montana, 59601, United States
Kalispell Medical Oncology at KRMC
Kalispell, Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell, Montana, 59901, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, 68848-1990, United States
Cancer Resource Center - Lincoln
Lincoln, Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106, United States
Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, 68124, United States
Lakeside Hospital
Omaha, Nebraska, 68130, United States
Creighton University Medical Center
Omaha, Nebraska, 68131-2197, United States
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, 08053, United States
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, 07503, United States
Somerset Medical Center
Somerville, New Jersey, 08876, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, 08755, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043, United States
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees Township, New Jersey, 08043, United States
Lovelace Medical Center - Downtown
Albuquerque, New Mexico, 87102, United States
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87131-5636, United States
University of New Mexico Cancer Center - South
Las Cruces, New Mexico, 88011, United States
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, 12801, United States
Beth Israel Medical Center - Petrie Division
New York, New York, 10003-3803, United States
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
New York, New York, 10025, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, 10461, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534, United States
Kinston Medical Specialists
Kinston, North Carolina, 28501, United States
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, 58501, United States
Mid Dakota Clinic, PC
Bismarck, North Dakota, 58501, United States
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, 58502, United States
MeritCare Broadway
Fargo, North Dakota, 58102, United States
CCOP - MeritCare Hospital
Fargo, North Dakota, 58122, United States
Roger Maris Cancer Center at MeritCare Hospital
Fargo, North Dakota, 58122, United States
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, 44307, United States
Cleveland Clinic Beachwood Family Health and Surgery Center
Beachwood, Ohio, 44122, United States
Wood County Oncology Center
Bowling Green, Ohio, 43402, United States
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, 44710-1799, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195, United States
Grandview Hospital
Dayton, Ohio, 45405, United States
Good Samaritan Hospital
Dayton, Ohio, 45406, United States
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, 45409, United States
Samaritan North Cancer Care Center
Dayton, Ohio, 45415, United States
CCOP - Dayton
Dayton, Ohio, 45420, United States
Community Cancer Center
Elyria, Ohio, 44035, United States
Hematology Oncology Center
Elyria, Ohio, 44035, United States
Blanchard Valley Medical Associates
Findlay, Ohio, 45840, United States
Middletown Regional Hospital
Franklin, Ohio, 45005-1066, United States
Wayne Hospital
Greenville, Ohio, 45331, United States
Cleveland Clinic Cancer Center
Independence, Ohio, 44131, United States
Charles F. Kettering Memorial Hospital
Kettering, Ohio, 45429, United States
Lima Memorial Hospital
Lima, Ohio, 45804, United States
Northwest Ohio Oncology Center
Maumee, Ohio, 43537-1839, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, 44124, United States
St. Charles Mercy Hospital
Oregon, Ohio, 43616, United States
Toledo Clinic - Oregon
Oregon, Ohio, 43616, United States
Parma Community General Hospital
Parma, Ohio, 44129, United States
North Coast Cancer Care, Incorporated
Sandusky, Ohio, 44870, United States
Cleveland Clinic Foundation - Strongsville
Strongsville, Ohio, 44136, United States
Flower Hospital Cancer Center
Sylvania, Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin, Ohio, 44883, United States
Toledo Hospital
Toledo, Ohio, 43606, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608, United States
Medical University of Ohio Cancer Center
Toledo, Ohio, 43614, United States
CCOP - Toledo Community Hospital
Toledo, Ohio, 43617, United States
St. Anne Mercy Hospital
Toledo, Ohio, 43623, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, 43623, United States
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, 45373-1300, United States
Fulton County Health Center
Wauseon, Ohio, 43567, United States
Cleveland Clinic - Wooster
Wooster, Ohio, 44691, United States
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Air Force Base, Ohio, 45433-5529, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, 45385, United States
Cancer Care Associates - Norman
Norman, Oklahoma, 73071, United States
Cancer Care Associates - Mercy Campus
Oklahoma City, Oklahoma, 73120, United States
Doylestown Hospital Cancer Center
Doylestown, Pennsylvania, 18901, United States
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Lancaster General Hospital
Lancaster, Pennsylvania, 17604, United States
St. Mary Regional Cancer Center
Langhorne, Pennsylvania, 19047, United States
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541, United States
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, 19464, United States
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, 57117-5039, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390, United States
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, 22401, United States
Island Hospital Cancer Care Center at Island Hospital
Anacortes, Washington, 98221, United States
St. Joseph Cancer Center
Bellingham, Washington, 98225, United States
Olympic Hematology and Oncology
Bremerton, Washington, 98310, United States
Highline Medical Center Cancer Center
Burien, Washington, 98166, United States
Swedish Medical Center - Issaquah Campus
Issaquah, Washington, 98029, United States
Columbia Basin Hematology
Kennewick, Washington, 99336, United States
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, 98274, United States
Harrison Poulsbo Hematology and Onocology
Poulsbo, Washington, 98370, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Minor and James Medical, PLLC
Seattle, Washington, 98104, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Group Health Central Hospital
Seattle, Washington, 98112, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98122-4307, United States
Polyclinic First Hill
Seattle, Washington, 98122, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, 98195, United States
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, 98284, United States
Cancer Care Northwest - Spokane South
Spokane, Washington, 99202, United States
Evergreen Hematology and Oncology, PS
Spokane, Washington, 99218, United States
Wenatchee Valley Medical Center
Wenatchee, Washington, 98801-2028, United States
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, 25304, United States
Langlade Memorial Hospital
Antigo, Wisconsin, 54409, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54301-3526, United States
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, 54303, United States
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, 54303, United States
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, 54307-3508, United States
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311, United States
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, 54601, United States
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, 54221-1450, United States
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, 54143, United States
Vince Lombardi Cancer Clinic - Marinette
Marinette, Wisconsin, 54143, United States
D.N. Greenwald Center
Mukwonago, Wisconsin, 53149, United States
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, 53066, United States
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, 54154, United States
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, 54904, United States
St. Nicholas Hospital
Sheboygan, Wisconsin, 53081, United States
Vince Lombardi Cancer Clinic - Sheboygan
Sheboygan, Wisconsin, 53081, United States
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, 54235, United States
Aurora Medical Center
Summit, Wisconsin, 53066, United States
Vince Lombardi Cancer Clinic - Two Rivers
Two Rivers, Wisconsin, 54241, United States
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, 53188, United States
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, 54401, United States
Riverview UW Cancer Center at Riverview Hospital
Wisconsin Rapids, Wisconsin, 54494, United States
Rocky Mountain Oncology
Casper, Wyoming, 82609, United States
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6, Canada
Instituto Nacional de Enfermedades Neoplasicas
Lima, Lima 34, Peru
Related Publications (1)
Stearns V, ONeill A, Schneider BP, Skaar TC, Liu MC, Lohrisch C, Goetz MP, Vallejos CS, Sparano JA, Villa D, Silverman P, Cheema PS, Moore DF Jr, Sledge GW Jr. CYP2D6 activity in patients with metastatic breast cancer treated with single agent tamoxifen: results from ECOG-ACRIN E3108. Breast Cancer Res Treat. 2025 Feb;209(3):595-602. doi: 10.1007/s10549-024-07519-z. Epub 2024 Oct 21.
PMID: 39432161DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Statistician
- Organization
- ECOG-ACRIN Statistical Office
Study Officials
- PRINCIPAL INVESTIGATOR
Vered Stearns, MD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2010
First Posted
May 17, 2010
Study Start
January 7, 2011
Primary Completion
November 30, 2020
Study Completion
December 1, 2022
Last Updated
June 29, 2023
Results First Posted
March 14, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will share
Individual participant data may be made available upon request as per the ECOG-ACRIN Data Sharing Policy.