Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by National Cancer Institute (NCI).
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01124695
First received: May 14, 2010
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: tamoxifen citrate
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Prospective Trial Correlating Progression Free Survival With CYP2D6 Activity in Patients With Metastatic Breast Cancer Treated With Single Agent Tamoxifen

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Correlation between CYP2D6 score (0 vs 1-2) and progression-free survival (PFS) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation of CYP2D6 score (0 vs 1 vs 2) with PFS [ Designated as safety issue: No ]
  • Correlation of CYP2D6 score (0 vs 1-2) with PFS at 6 months [ Designated as safety issue: No ]
  • Correlation of endoxifen concentration with response [ Designated as safety issue: No ]
  • Correlation of CYP2D6 with response [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: September 2010
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To correlate CYP2D6 score (0 vs 1-2) and progression-free survival (PFS) of patients with metastatic breast cancer treated with tamoxifen citrate.

Secondary

  • To correlate CYP2D6 score (0 vs 1 vs 2) and PFS of patients treated with this regimen.
  • To correlate CYP2D6 score (0 vs 1 + 2) and the proportion of these patients who are PFS at 6 months.
  • To correlate endoxifen concentration with response in patients treated with this regimen.
  • To correlate CYP2D6 with response in patients treated with this regimen.
  • To correlate the presence of candidate estrogen receptor (ESR) 1 and 2 variant alleles, UGT7, SULT1A1, and other candidate genes to PFS.

OUTLINE: This is a multicenter study.

Patients receive oral tamoxifen citrate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities.

Blood, plasma, and tissue samples are collected periodically for laboratory studies.

After completion of study therapy, patients are followed up every 3-6 months for 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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
    • Receptor testing on metastatic disease is not required
  • Measurable or non-measurable disease
  • History of 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

    • No known leptomeningeal disease allowed

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Menopausal status not specified
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases present)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception
  • No medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, assessment of response, or anticipated toxicities
  • More than 5 years since prior invasive malignancies except curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior investigational agents in the metastatic setting

    • Other prior investigational agents in any setting must have been completed at least 6 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

    • Prior tamoxifen for advanced disease is not allowed
  • No prior chemotherapy or trastuzumab (Herceptin) for metastatic disease

    • Prior chemotherapy, trastuzumab, or bevacizumab in the adjuvant setting allowed provided it has been completed ≥ 4 weeks before study therapy
  • Patients must not have had more than 2 lines of non-hormonal treatment in the locally advanced or metastatic setting, including trastuzumab (Herceptin), bevacizumab, or other biologics

    • Treatment in the advanced setting must have been completed at least 2 weeks prior to study initiation
  • Prior aromatase inhibitors (e.g., anastrozole, letrozole, exemestane, aminoglutethamide) are allowed in the adjuvant or metastatic setting
  • At least 2 weeks since prior and no concurrent medications that are strong to moderate inhibitors of CYP2D6 and may alter tamoxifen citrate metabolism including, but not limited to, any of the following:

    • Paroxetine (Paxil)
    • Fluoxetine (Prozac)
    • Bupropion (Wellbutrin)
    • Quinidine (Cardioquin)
  • Patients may not initiate 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
  • Concurrent radiotherapy to painful sites of bone disease or areas of impending fractures allowed provided the following criteria are met:

    • Radiotherapy was initiated before study entry
    • Sites of measurable or non-measurable disease are outside the radiotherapy port
    • Recovered from prior radiotherapy
  • No other concurrent hormonal therapy
  • No concurrent chemotherapy
  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: NCT01124695

  Hide Study Locations
Locations
United States, Alabama
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
University of South Alabama Mitchell Cancer Institute
Mobile, Alabama, United States, 36604
United States, Arkansas
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States, 72903
United States, California
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
Marysville, California, United States, 95901
Mercy Cancer Center at Mercy Medical Center
Merced, California, United States, 95340
Camino Medical Group - Treatment Center
Mountain View, California, United States, 94040
St. Joseph Hospital Regional Cancer Center - Orange
Orange, California, United States, 92868
Palo Alto Medical Foundation
Palo Alto, California, United States, 94301
Valley Medical Oncology Consultants - Pleasanton
Pleasanton, California, United States, 94588
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Tahoe Forest Cancer Center
Truckee, California, United States, 96161
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
St. Anthony Central Hospital
Denver, Colorado, United States, 80204
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
St. Joseph Hospital
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
CCOP - Colorado Cancer Research Program
Denver, Colorado, United States, 80222
Swedish Medical Center
Englewood, Colorado, United States, 80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
North Colorado Medical Center
Greeley, Colorado, United States, 80631
Littleton Adventist Hospital
Littleton, Colorado, United States, 80122
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80501
McKee Medical Center
Loveland, Colorado, United States, 80539
Parker Adventist Hospital
Parker, Colorado, United States, 80138
St. Mary - Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Exempla Lutheran Medical Center
Wheat Ridge, Colorado, United States, 80033
United States, Connecticut
Middlesex Hospital Cancer Center
Middletown, Connecticut, United States, 06457
Yale Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, Delaware
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, District of Columbia
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Washington Cancer Institute at Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Broward General Medical Center Cancer Center
Fort Lauderdale, Florida, United States, 33316
United States, Georgia
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States, 31405
United States, Hawaii
Kapiolani Medical Center at Pali Momi
Aiea, Hawaii, United States, 96701
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
OnCare Hawaii, Incorporated - Lusitana
Honolulu, Hawaii, United States, 96813
Queen's Cancer Institute at Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital, Incorporated
Honolulu, Hawaii, United States, 96813
Hawaii Medical Center - East
Honolulu, Hawaii, United States, 96817
OnCare Hawaii, Incorporated - Kuakini
Honolulu, Hawaii, United States, 96817
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
Maui Memorial Medical Center
Wailuku, Hawaii, United States, 96793
Pacific Cancer Institute - Maui
Wailuku, Hawaii, United States, 96793
United States, Illinois
Louis A. Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, United States, 62526
Elmhurst Memorial Hospital
Elmhurst, Illinois, United States, 60126
La Grange Memorial Hospital
La Grange, Illinois, United States, 60525
West Suburban Center for Cancer Care
River Forest, Illinois, United States, 60305
United States, Indiana
St. Francis Hospital and Health Centers - Beech Grove Campus
Beech Grove, Indiana, United States, 46107
Elkhart Clinic, LLC
Elkhart, Indiana, United States, 46514-2098
Michiana Hematology-Oncology, PC - Elkhart
Elkhart, Indiana, United States, 46514
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
William N. Wishard Memorial Hospital
Indianapolis, Indiana, United States, 46202
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Michiana Hematology-Oncology, PC - South Bend
Mishawaka, Indiana, United States, 46545-1470
Saint Joseph Regional Medical Center
Mishawaka, Indiana, United States, 46545-1470
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, United States, 47303-3499
Michiana Hematology Oncology PC - Plymouth
Plymouth, Indiana, United States, 46563
Reid Hospital & Health Care Services
Richmond, Indiana, United States, 47374
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Michiana Hematology Oncology PC - La Porte
Westville, Indiana, United States, 46391
United States, Iowa
McFarland Clinic, PC
Ames, Iowa, United States, 50010
Medical Oncology and Hematology Associates - West Des Moines
Clive, Iowa, United States, 50325
Mercy Cancer Center - West Lakes
Clive, Iowa, United States, 50325
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51102
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Methodist West Hospital
West Des Moines, Iowa, United States, 50266-7700
United States, Kansas
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas, PA - Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas, PA - McPherson
McPherson, Kansas, United States, 67460
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
CCOP - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Union Hospital of Cecil County
Elkton MD, Maryland, United States, 21921
United States, Michigan
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-0942
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Dickinson County Healthcare System
Iron Mountain, Michigan, United States, 49801
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
Mercy Memorial Hospital - Monroe
Monroe, Michigan, United States, 48162
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, United States, 49085
Lakeside Cancer Specialists, PLLC
Saint Joseph, Michigan, United States, 49085
United States, Minnesota
MeritCare Bemidji
Bemidji, Minnesota, United States, 56601
St. Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, United States, 55805-1983
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Miller - Dwan Medical Center
Duluth, Minnesota, United States, 55805
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Immanuel St. Joseph's
Mankato, Minnesota, United States, 56002
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, United States, 55109
Minnesota Oncology - Maplewood
Maplewood, Minnesota, United States, 55109
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
New Ulm Medical Center
New Ulm, Minnesota, United States, 56073
Humphrey Cancer Center at North Memorial Outpatient Center
Robbinsdale, Minnesota, United States, 55422-2900
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Park Nicollet Cancer Center
Saint Louis Park, Minnesota, United States, 55416
United Hospital
Saint Paul, Minnesota, United States, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, United States, 55379
Regions Hospital Cancer Care Center
St. Paul, Minnesota, United States, 55101
Lakeview Hospital
Stillwater, Minnesota, United States, 55082
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Willmar Cancer Center at Rice Memorial Hospital
Willmar, Minnesota, United States, 56201
Minnesota Oncology - Woodbury
Woodbury, Minnesota, United States, 55125
United States, Mississippi
University of Mississippi Cancer Clinic
Jackson, Mississippi, United States, 39216
United States, Missouri
Central Care Cancer Center at Carrie J. Babb Cancer Center
Bolivar, Missouri, United States, 65613
Skaggs Cancer Center at Skaggs Regional Medical Center
Branson, Missouri, United States, 65616
Southeast Cancer Center
Cape Girardeau, Missouri, United States, 63703
Goldschmidt Cancer Center
Jefferson City, Missouri, United States, 65109
Mercy Clinic Cancer and Hematology - Rolla
Rolla, Missouri, United States, 65401
Missouri Baptist Cancer Center
Saint Louis, Missouri, United States, 63131
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
United States, Montana
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
St. Vincent Healthcare Cancer Care Services
Billings, Montana, United States, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59102
Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
Bozeman Deaconess Cancer Center
Bozeman, Montana, United States, 59715
St. James Healthcare Cancer Care
Butte, Montana, United States, 59701
Big Sky Oncology
Great Falls, Montana, United States, 59405-5309
Sletten Cancer Institute at Benefis Healthcare
Great Falls, Montana, United States, 59405
St. Peter's Hospital
Helena, Montana, United States, 59601
Kalispell Medical Oncology at KRMC
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
United States, Nebraska
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney, Nebraska, United States, 68848-1990
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Lakeside Hospital
Omaha, Nebraska, United States, 68130
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
United States, Nevada
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Marlton, New Jersey, United States, 08053
St. Joseph's Hospital and Medical Center
Paterson, New Jersey, United States, 07503
Somerset Medical Center
Somerville, New Jersey, United States, 08876
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States, 08755
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
Fox Chase Virtua Health Cancer Program at Virtua West Jersey
Voorhees, New Jersey, United States, 08043
United States, New Mexico
Lovelace Medical Center - Downtown
Albuquerque, New Mexico, United States, 87102
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87131-5636
University of New Mexico Cancer Center - South
Las Cruces, New Mexico, United States, 88011
United States, New York
Albert Einstein Cancer Center at Albert Einstein College of Medicine
Bronx, New York, United States, 10461
Charles R. Wood Cancer Center at Glens Falls Hospital
Glens Falls, New York, United States, 12801
Beth Israel Medical Center - Petrie Division
New York, New York, United States, 10003-3803
St. Luke's - Roosevelt Hospital Center - St.Luke's Division
New York, New York, United States, 10025
United States, North Carolina
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, United States, 27534
Kinston Medical Specialists
Kinston, North Carolina, United States, 28501
United States, North Dakota
Medcenter One Hospital Cancer Care Center
Bismarck, North Dakota, United States, 58501
Mid Dakota Clinic, PC
Bismarck, North Dakota, United States, 58501
St. Alexius Medical Center Cancer Center
Bismarck, North Dakota, United States, 58502
MeritCare Broadway
Fargo, North Dakota, United States, 58102
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
Roger Maris Cancer Center at MeritCare Hospital
Fargo, North Dakota, United States, 58122
United States, Ohio
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44307
Cleveland Clinic Beachwood Family Health and Surgery Center
Beachwood, Ohio, United States, 44122
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, United States, 44710-1799
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Grandview Hospital
Dayton, Ohio, United States, 45405
Good Samaritan Hospital
Dayton, Ohio, United States, 45406
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Samaritan North Cancer Care Center
Dayton, Ohio, United States, 45415
CCOP - Dayton
Dayton, Ohio, United States, 45420
Community Cancer Center
Elyria, Ohio, United States, 44035
Hematology Oncology Center
Elyria, Ohio, United States, 44035
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
Middletown Regional Hospital
Franklin, Ohio, United States, 45005-1066
Wayne Hospital
Greenville, Ohio, United States, 45331
Cleveland Clinic Cancer Center
Independence, Ohio, United States, 44131
Charles F. Kettering Memorial Hospital
Kettering, Ohio, United States, 45429
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537-1839
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
Parma Community General Hospital
Parma, Ohio, United States, 44129
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Cleveland Clinic Foundation - Strongsville
Strongsville, Ohio, United States, 44136
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
Toledo Hospital
Toledo, Ohio, United States, 43606
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43617
St. Anne Mercy Hospital
Toledo, Ohio, United States, 43623
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
UVMC Cancer Care Center at Upper Valley Medical Center
Troy, Ohio, United States, 45373-1300
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Cleveland Clinic - Wooster
Wooster, Ohio, United States, 44691
United States Air Force Medical Center - Wright-Patterson
Wright-Patterson Afb, Ohio, United States, 45433-5529
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
Xenia, Ohio, United States, 45385
United States, Oklahoma
Cancer Care Associates - Norman
Norman, Oklahoma, United States, 73071
Cancer Care Associates - Mercy Campus
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Doylestown Hospital Cancer Center
Doylestown, Pennsylvania, United States, 18901
Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
St. Mary Regional Cancer Center
Langhorne, Pennsylvania, United States, 19047
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, United States, 19464
United States, South Dakota
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
United States, Virginia
Fredericksburg Oncology, Incorporated
Fredericksburg, Virginia, United States, 22401
United States, Washington
Island Hospital Cancer Care Center at Island Hospital
Anacortes, Washington, United States, 98221
St. Joseph Cancer Center
Bellingham, Washington, United States, 98225
Olympic Hematology and Oncology
Bremerton, Washington, United States, 98310
Highline Medical Center Cancer Center
Burien, Washington, United States, 98166
Swedish Medical Center - Issaquah Campus
Issaquah, Washington, United States, 98029
Columbia Basin Hematology
Kennewick, Washington, United States, 99336
Skagit Valley Hospital Cancer Care Center
Mount Vernon, Washington, United States, 98274
Harrison Poulsbo Hematology and Onocology
Poulsbo, Washington, United States, 98370
Harborview Medical Center
Seattle, Washington, United States, 98104
Minor and James Medical, PLLC
Seattle, Washington, United States, 98104
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Group Health Central Hospital
Seattle, Washington, United States, 98112
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, United States, 98122-4307
Polyclinic First Hill
Seattle, Washington, United States, 98122
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195
North Puget Oncology at United General Hospital
Sedro-Woolley, Washington, United States, 98284
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, 98801-2028
United States, West Virginia
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Langlade Memorial Hospital
Antigo, Wisconsin, United States, 54409
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54301-3526
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
St. Mary's Hospital Medical Center - Green Bay
Green Bay, Wisconsin, United States, 54303
St. Vincent Hospital Regional Cancer Center
Green Bay, Wisconsin, United States, 54307-3508
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
Green Bay, Wisconsin, United States, 54311
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, United States, 54601
Holy Family Memorial Medical Center Cancer Care Center
Manitowoc, Wisconsin, United States, 54221-1450
Bay Area Cancer Care Center at Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Vince Lombardi Cancer Clinic - Marinette
Marinette, Wisconsin, United States, 54143
D.N. Greenwald Center
Mukwonago, Wisconsin, United States, 53149
Regional Cancer Center at Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Vince Lombardi Cancer Clinic - Oshkosh
Oshkosh, Wisconsin, United States, 54904
St. Nicholas Hospital
Sheboygan, Wisconsin, United States, 53081
Vince Lombardi Cancer Clinic - Sheboygan
Sheboygan, Wisconsin, United States, 53081
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Aurora Medical Center
Summit, Wisconsin, United States, 53066
Vince Lombardi Cancer Clinic - Two Rivers
Two Rivers, Wisconsin, United States, 54241
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
University of Wisconcin Cancer Center at Aspirus Wausau Hospital
Wausau, Wisconsin, United States, 54401
Riverview UW Cancer Center at Riverview Hospital
Wisconsin Rapids, Wisconsin, United States, 54494
United States, Wyoming
Rocky Mountain Oncology
Casper, Wyoming, United States, 82609
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Cancer Centre
Vancouver, British Columbia, Canada, V5Z 4E6
Peru
Instituto Nacional de Enfermedades Neoplasicas
Lima, Peru, Lima 34
Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Vered Stearns, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT01124695     History of Changes
Other Study ID Numbers: CDR0000672523  ECOG-E3108 
Study First Received: May 14, 2010
Last Updated: December 6, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
estrogen receptor-positive breast cancer
male breast cancer
progesterone receptor-positive breast cancer
recurrent breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Citric Acid
Tamoxifen
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on December 02, 2016