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Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01573442
Recruitment Status : Recruiting
First Posted : April 9, 2012
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Brief Summary:
This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia (joint pain) caused by anastrozole or letrozole. Testosterone may help relieve moderate or severe arthralgia associated with the use of aromatase inhibitors, such as anastrozole or letrozole.

Condition or disease Intervention/treatment Phase
Arthralgia Breast Cancer Hot Flashes Musculoskeletal Complications Sexual Dysfunction Drug: testosterone Other: placebo Phase 3

Detailed Description:

This is a randomized, placebo-controlled, phase III trial evaluating subcutaneous testosterone for the alleviation of aromatase inhibitor induced arthralgia. A parallel group design will be utilized for this two-arm study: subcutaneous testosterone vs. placebo. Patients are stratified according to baseline pain score (5-6 vs. 7-10) and age (< 50 vs. 50-60 vs. > 60). The primary objective is to determine whether testosterone will reduce AI-induced arthralgia and associated joint symptoms. The secondary objective is to explore whether testosterone will have an acceptable safety and tolerability profile, with particular reference to androgenic adverse events including acne, hirsutism, and alopecia.

Patients are followed up to six months as defined in the protocol.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias
Study Start Date : August 2013
Estimated Primary Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm I
Patients receive testosterone (0.264mL) topical application daily for six months.
Drug: testosterone
10.4 mg
Placebo Comparator: Arm II
Patients receive placebo (0.264mL) topical application daily for six months.
Other: placebo



Primary Outcome Measures :
  1. Intra-patient change in joint pain at 3 months from baseline as measured by item #3 (average) of the Brief Pain Inventory [ Time Frame: Up to 3 months ]
  2. Proportion of women with changes in pain at least 10 points on a converted 0-100 scale at 3 months from baseline [ Time Frame: Up to 3 months ]
    Proportion of women with an improvement (reduced pain) of at least 10 points (on a converted 0-100 scale)

  3. The intra-patient change in joint pain at 6 months from baseline as measured by item #3 (average) of the Brief Pain Inventory for aromatase inhibitor arthralgias (BPI-AIA). [ Time Frame: Up to 6 months ]
  4. The intra-patient changes in joint pain at each month from baseline as measured by the BPI-AIA. [ Time Frame: Up to 6 months ]

Secondary Outcome Measures :
  1. Incidence of toxicities assessed using the Common Terminology Criteria for Adverse Events (CTCAE) 4.0. [ Time Frame: Up to 6 months ]
  2. Alopecia as reported by the patient using CTCAE 4.0 [ Time Frame: Up to 6 months ]
  3. Acne as reported by the patient using CTCAE 4.0 [ Time Frame: Up to 6 months ]
  4. Hirsutism as reported by the patient using CTCAE 4.0 [ Time Frame: Up to 6 months ]
  5. The change of hot flashes during the first two months from baseline as measured by hot flash diary [ Time Frame: Up to 2 months ]
  6. The change of libido from baseline as measured by POMS monthly. [ Time Frame: Up to 6 months ]
  7. The change of menopause specific quality of life from baseline as measured by MENQOL monthly. [ Time Frame: Up to 6 months ]
  8. The intrapatient change in joint pain for each month from baseline as measured by item#1 (worst) of the BPI-AIA. [ Time Frame: Up to 6 months ]
  9. The intrapatient change in joint pain for each month from baseline as measured by item#2 (least) of the BPI-AIA. [ Time Frame: Up to 6 months ]
  10. The intrapatient change in joint pain for each month from baseline as measured by item#4 (right now) of the BPI-AIA. [ Time Frame: Up to 6 months ]
  11. The intrapatient change in joint pain for each month from baseline as measured by item#5 (stiffness) of the BPI-AIA. [ Time Frame: Up to 6 months ]
  12. The intrapatient change in activity level (interference of activity) for each month from baseline as measured by item#6 (interference) of the BPI-AIA. [ Time Frame: Up to 6 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  1. Age ≥ 18 years
  2. Receiving anastrozole (1mg) or letrozole (2.5 mg) orally once a day, for ≥ 21 days prior to registration and plan to continue it throughout the duration of study
  3. Body Mass Index (BMI) between 18 and 35 kg/m^2
  4. Women who have undergone a total mastectomy or breast conserving surgery for primary breast cancer +/-chemo, +/-radiotherapy.
  5. Must have BOTH ER and PR receptor-positive tumors and BOTH must be ≥26% positive. Alternatively, if ER and PR are determined by Allred score, the score needs to be 5 or higher
  6. Women who are postmenopausal by surgery, radiotherapy or presence of natural amenorrhea ≥ 12 months
  7. ≥ 5/10 arthralgia (in hands, wrist, knees, or hips) while being treated with anastrozole or letrozole which is felt by the patient to be caused by their aromatase inhibitor as defined in the protocol. Note: Patients may, or may not, be taking non-opioid analgesics
  8. Ability to complete questionnaire(s) by themselves or with assistance
  9. ECOG Performance Status (PS) 0, 1 or 2
  10. Willing to provide informed written consent
  11. Willing to return to an Alliance enrolling institution for follow-up
  12. Willing to provide blood samples for correlative research purposes
  13. Laboratory values prior to registration as defined in the protocol:

    1. Creatinine ≤1.5 x ULN
    2. Hemoglobin > 11 g/dL
    3. WBC > 3.0
    4. Platelet Count > 100,000
    5. SGOT (AST) ≤ 1.5 x ULN

Exclusion Criteria:

  1. Presence of residual or recurrent cancer (locally or metastatic)
  2. Diabetes mellitus or glucose intolerance, defined as a fasting glucose >125 mg/dL
  3. History of coronary artery disease (angina or myocardial infarction)
  4. Patients on hormone replacement therapy (HRT) ≤ 4 weeks prior to registration. This includes the use of vaginal estrogen therapy.
  5. Known hypersensitivity to any component of testosterone.
  6. Prolonged systemic corticosteroid treatment, except for topical applications (e.g. for rash), inhaled sprays (e.g. for obstructive airway diseases), eye drops or local insertion (e.g. intra-articular). Note: Short duration (< 2 weeks) of systemic corticosteroids is allowed (e.g. for chronic obstructive pulmonary disease) but not within 30 days prior to registration.
  7. Receiving any other investigational agent
  8. History of a deep venous thrombosis or a thromboembolism
  9. Concurrent use of the aromatase inhibitor exemestane, as it is structurally similar to an androgen
  10. Concurrent radiation therapy or chemotherapy
  11. Current or planned use of cyclosporine, anticoagulants, oxphenbutazone, insulin, oral or injectable vitamin D doses over 4,000IU/day, or tamoxifen

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01573442


Contacts
Contact: Charles Loprinzi, MD (507) 284-4565

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Locations
United States, Alaska
Anchorage Associates in Radiation Medicine Active, not recruiting
Anchorage, Alaska, United States, 98508
Anchorage Radiation Therapy Center Active, not recruiting
Anchorage, Alaska, United States, 99504
Alaska Breast Care and Surgery LLC Active, not recruiting
Anchorage, Alaska, United States, 99508
Alaska Oncology and Hematology LLC Active, not recruiting
Anchorage, Alaska, United States, 99508
Alaska Women's Cancer Care Active, not recruiting
Anchorage, Alaska, United States, 99508
Anchorage Oncology Centre Active, not recruiting
Anchorage, Alaska, United States, 99508
Katmai Oncology Group Active, not recruiting
Anchorage, Alaska, United States, 99508
Providence Alaska Medical Center Active, not recruiting
Anchorage, Alaska, United States, 99508
United States, Arkansas
CHI Saint Vincent Cancer Center Hot Springs Active, not recruiting
Hot Springs, Arkansas, United States, 71913
United States, California
Sutter Auburn Faith Hospital Active, not recruiting
Auburn, California, United States, 95602
Sutter Cancer Centers Radiation Oncology Services-Auburn Active, not recruiting
Auburn, California, United States, 95603
Alta Bates Summit Medical Center-Herrick Campus Active, not recruiting
Berkeley, California, United States, 94704
Providence Saint Joseph Medical Center/Disney Family Cancer Center Active, not recruiting
Burbank, California, United States, 91505
Mills-Peninsula Medical Center Active, not recruiting
Burlingame, California, United States, 94010
Sutter Cancer Centers Radiation Oncology Services-Cameron Park Active, not recruiting
Cameron Park, California, United States, 95682
Eden Hospital Medical Center Active, not recruiting
Castro Valley, California, United States, 94546
Sutter Davis Hospital Active, not recruiting
Davis, California, United States, 95616
Epic Care-Dublin Active, not recruiting
Dublin, California, United States, 94568
Bay Area Breast Surgeons Inc Active, not recruiting
Emeryville, California, United States, 94608
Epic Care Partners in Cancer Care Active, not recruiting
Emeryville, California, United States, 94608
Palo Alto Medical Foundation-Fremont Active, not recruiting
Fremont, California, United States, 94538
Washington Hospital Active, not recruiting
Fremont, California, United States, 94538
Cedars Sinai Medical Center Active, not recruiting
Los Angeles, California, United States, 90048
Contra Costa Regional Medical Center Active, not recruiting
Martinez, California, United States, 94553-3156
Memorial Medical Center Active, not recruiting
Modesto, California, United States, 95355
Palo Alto Medical Foundation-Camino Division Active, not recruiting
Mountain View, California, United States, 94040
Palo Alto Medical Foundation-Gynecologic Oncology Active, not recruiting
Mountain View, California, United States, 94040
Sutter Cancer Research Consortium Active, not recruiting
Novato, California, United States, 94945
Alta Bates Summit Medical Center - Summit Campus Active, not recruiting
Oakland, California, United States, 94609
Bay Area Tumor Institute Active, not recruiting
Oakland, California, United States, 94609
Palo Alto Medical Foundation Health Care Active, not recruiting
Palo Alto, California, United States, 94301
Sutter Cancer Centers Radiation Oncology Services-Roseville Active, not recruiting
Roseville, California, United States, 95661
Sutter Roseville Medical Center Active, not recruiting
Roseville, California, United States, 95661
Sutter Medical Center Sacramento Active, not recruiting
Sacramento, California, United States, 95816
California Pacific Medical Center-Pacific Campus Active, not recruiting
San Francisco, California, United States, 94115
Palo Alto Medical Foundation-Santa Cruz Active, not recruiting
Santa Cruz, California, United States, 95065
Sutter Pacific Medical Foundation Active, not recruiting
Santa Rosa, California, United States, 95403
Palo Alto Medical Foundation-Sunnyvale Active, not recruiting
Sunnyvale, California, United States, 94086
Sutter Cancer Centers Radiation Oncology Services-Vacaville Active, not recruiting
Vacaville, California, United States, 95687
Sutter Solano Medical Center/Cancer Center Active, not recruiting
Vallejo, California, United States, 94589
United States, Colorado
Rocky Mountain Cancer Centers-Aurora Active, not recruiting
Aurora, Colorado, United States, 80012
The Medical Center of Aurora Active, not recruiting
Aurora, Colorado, United States, 80012
Boulder Community Hospital Active, not recruiting
Boulder, Colorado, United States, 80301
Rocky Mountain Cancer Centers-Boulder Active, not recruiting
Boulder, Colorado, United States, 80304
Penrose-Saint Francis Healthcare Active, not recruiting
Colorado Springs, Colorado, United States, 80907
Rocky Mountain Cancer Centers-Penrose Active, not recruiting
Colorado Springs, Colorado, United States, 80907
Porter Adventist Hospital Active, not recruiting
Denver, Colorado, United States, 80210
Colorado Blood Cancer Institute Active, not recruiting
Denver, Colorado, United States, 80218
Presbyterian - Saint Lukes Medical Center - Health One Active, not recruiting
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers-Midtown Active, not recruiting
Denver, Colorado, United States, 80218
SCL Health Saint Joseph Hospital Active, not recruiting
Denver, Colorado, United States, 80218
Rocky Mountain Cancer Centers-Rose Active, not recruiting
Denver, Colorado, United States, 80220
Rose Medical Center Active, not recruiting
Denver, Colorado, United States, 80220
Colorado Cancer Research Program NCORP Suspended
Denver, Colorado, United States, 80222
Mercy Medical Center Active, not recruiting
Durango, Colorado, United States, 81301
Southwest Oncology PC Active, not recruiting
Durango, Colorado, United States, 81301
Comprehensive Cancer Care and Research Institute of Colorado LLC Active, not recruiting
Englewood, Colorado, United States, 80113
Swedish Medical Center Active, not recruiting
Englewood, Colorado, United States, 80113
Mountain Blue Cancer Care Center Active, not recruiting
Golden, Colorado, United States, 80401
North Colorado Medical Center Active, not recruiting
Greeley, Colorado, United States, 80631
Rocky Mountain Cancer Centers-Greenwood Village Active, not recruiting
Greenwood Village, Colorado, United States, 80111
Rocky Mountain Cancer Centers-Lakewood Active, not recruiting
Lakewood, Colorado, United States, 80228
Saint Anthony Hospital Active, not recruiting
Lakewood, Colorado, United States, 80228
Rocky Mountain Cancer Centers-Littleton Active, not recruiting
Littleton, Colorado, United States, 80120
Littleton Adventist Hospital Active, not recruiting
Littleton, Colorado, United States, 80122
Rocky Mountain Cancer Centers-Sky Ridge Active, not recruiting
Lone Tree, Colorado, United States, 80124
Sky Ridge Medical Center Active, not recruiting
Lone Tree, Colorado, United States, 80124
Longmont United Hospital Active, not recruiting
Longmont, Colorado, United States, 80501
Rocky Mountain Cancer Centers-Longmont Active, not recruiting
Longmont, Colorado, United States, 80501
McKee Medical Center Active, not recruiting
Loveland, Colorado, United States, 80539
Parker Adventist Hospital Active, not recruiting
Parker, Colorado, United States, 80138
Rocky Mountain Cancer Centers-Parker Active, not recruiting
Parker, Colorado, United States, 80138
Saint Mary Corwin Medical Center Active, not recruiting
Pueblo, Colorado, United States, 81004
Rocky Mountain Cancer Centers - Pueblo Active, not recruiting
Pueblo, Colorado, United States, 81008
Rocky Mountain Cancer Centers-Thornton Active, not recruiting
Thornton, Colorado, United States, 80260
SCL Health Lutheran Medical Center Active, not recruiting
Wheat Ridge, Colorado, United States, 80033
United States, Delaware
Beebe Medical Center Active, not recruiting
Lewes, Delaware, United States, 19958
Christiana Gynecologic Oncology LLC Suspended
Newark, Delaware, United States, 19713
Delaware Clinical and Laboratory Physicians PA Active, not recruiting
Newark, Delaware, United States, 19713
Helen F Graham Cancer Center Active, not recruiting
Newark, Delaware, United States, 19713
Medical Oncology Hematology Consultants PA Active, not recruiting
Newark, Delaware, United States, 19713
Regional Hematology and Oncology PA Active, not recruiting
Newark, Delaware, United States, 19713
Christiana Care Health System-Christiana Hospital Active, not recruiting
Newark, Delaware, United States, 19718
Beebe Health Campus Active, not recruiting
Rehoboth Beach, Delaware, United States, 19971
Nanticoke Memorial Hospital Active, not recruiting
Seaford, Delaware, United States, 19973
Christiana Care Health System-Wilmington Hospital Active, not recruiting
Wilmington, Delaware, United States, 19801
United States, District of Columbia
MedStar Washington Hospital Center Active, not recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Lakeland Regional Health Hollis Cancer Center Active, not recruiting
Lakeland, Florida, United States, 33805
Florida Hospital Orlando Active, not recruiting
Orlando, Florida, United States, 32803
United States, Georgia
University Cancer and Blood Center LLC Active, not recruiting
Athens, Georgia, United States, 30607
Northside Hospital Active, not recruiting
Atlanta, Georgia, United States, 30342
Augusta University Medical Center Active, not recruiting
Augusta, Georgia, United States, 30912
John B Amos Cancer Center Active, not recruiting
Columbus, Georgia, United States, 31904
Dekalb Medical Center Active, not recruiting
Decatur, Georgia, United States, 30033
Central Georgia Gynecologic Oncology Active, not recruiting
Macon, Georgia, United States, 31201
Medical Center of Central Georgia Active, not recruiting
Macon, Georgia, United States, 31201
Memorial University Medical Center Active, not recruiting
Savannah, Georgia, United States, 31404
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler Active, not recruiting
Savannah, Georgia, United States, 31405
United States, Idaho
Saint Luke's Mountain States Tumor Institute Active, not recruiting
Boise, Idaho, United States, 83712
Kootenai Medical Center Active, not recruiting
Coeur d'Alene, Idaho, United States, 83814
Saint Luke's Mountain States Tumor Institute - Fruitland Active, not recruiting
Fruitland, Idaho, United States, 83619
Saint Luke's Mountain States Tumor Institute - Meridian Active, not recruiting
Meridian, Idaho, United States, 83642
Saint Luke's Mountain States Tumor Institute - Nampa Active, not recruiting
Nampa, Idaho, United States, 83686
Kootenai Cancer Center Active, not recruiting
Post Falls, Idaho, United States, 83854
Kootenai Cancer Clinic Active, not recruiting
Sandpoint, Idaho, United States, 83864
Saint Luke's Mountain States Tumor Institute-Twin Falls Active, not recruiting
Twin Falls, Idaho, United States, 83301
United States, Illinois
Rush - Copley Medical Center Active, not recruiting
Aurora, Illinois, United States, 60504
Saint Joseph Medical Center Active, not recruiting
Bloomington, Illinois, United States, 61701
Illinois CancerCare-Bloomington Active, not recruiting
Bloomington, Illinois, United States, 61704
Illinois CancerCare-Canton Active, not recruiting
Canton, Illinois, United States, 61520
Memorial Hospital of Carbondale Active, not recruiting
Carbondale, Illinois, United States, 62902
SIH Cancer Institute Active, not recruiting
Carterville, Illinois, United States, 62918
Illinois CancerCare-Carthage Active, not recruiting
Carthage, Illinois, United States, 62321
Centralia Oncology Clinic Active, not recruiting
Centralia, Illinois, United States, 62801
Weiss Memorial Hospital Active, not recruiting
Chicago, Illinois, United States, 60640
Carle on Vermilion Active, not recruiting
Danville, Illinois, United States, 61832
Cancer Care Center of Decatur Active, not recruiting
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital Active, not recruiting
Decatur, Illinois, United States, 62526
Carle Physician Group-Effingham Active, not recruiting
Effingham, Illinois, United States, 62401
Crossroads Cancer Center Active, not recruiting
Effingham, Illinois, United States, 62401
Illinois CancerCare-Eureka Active, not recruiting
Eureka, Illinois, United States, 61530
Illinois CancerCare-Galesburg Active, not recruiting
Galesburg, Illinois, United States, 61401
Western Illinois Cancer Treatment Center Active, not recruiting
Galesburg, Illinois, United States, 61401
Northwestern Medicine Cancer Center Delnor Active, not recruiting
Geneva, Illinois, United States, 60134
Ingalls Memorial Hospital Active, not recruiting
Harvey, Illinois, United States, 60426
Illinois CancerCare-Kewanee Clinic Active, not recruiting
Kewanee, Illinois, United States, 61443
AMITA Health Adventist Medical Center Active, not recruiting
La Grange, Illinois, United States, 60525
Illinois CancerCare-Macomb Active, not recruiting
Macomb, Illinois, United States, 61455
Carle Physician Group-Mattoon/Charleston Active, not recruiting
Mattoon, Illinois, United States, 61938
Garneau, Stewart C MD (UIA Investigator) Active, not recruiting
Moline, Illinois, United States, 61265
Porubcin, Michael MD (UIA Investigator) Active, not recruiting
Moline, Illinois, United States, 61265
Spector, David MD (UIA Investigator) Active, not recruiting
Moline, Illinois, United States, 61265
Trinity Medical Center Active, not recruiting
Moline, Illinois, United States, 61265
Good Samaritan Regional Health Center Active, not recruiting
Mount Vernon, Illinois, United States, 62864
Illinois CancerCare-Ottawa Clinic Active, not recruiting
Ottawa, Illinois, United States, 61350
Radiation Oncology of Northern Illinois Active, not recruiting
Ottawa, Illinois, United States, 61350
Illinois CancerCare-Pekin Active, not recruiting
Pekin, Illinois, United States, 61554
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Active, not recruiting
Pekin, Illinois, United States, 61554
Methodist Medical Center of Illinois Active, not recruiting
Peoria, Illinois, United States, 61603
Illinois CancerCare-Peoria Active, not recruiting
Peoria, Illinois, United States, 61615
OSF Saint Francis Radiation Oncology at Peoria Cancer Center Active, not recruiting
Peoria, Illinois, United States, 61615
OSF Saint Francis Medical Center Active, not recruiting
Peoria, Illinois, United States, 61637
Illinois CancerCare-Peru Active, not recruiting
Peru, Illinois, United States, 61354
Valley Radiation Oncology Active, not recruiting
Peru, Illinois, United States, 61354
Illinois CancerCare-Princeton Active, not recruiting
Princeton, Illinois, United States, 61356
West Suburban Medical Center Active, not recruiting
River Forest, Illinois, United States, 60305
Central Illinois Hematology Oncology Center Active, not recruiting
Springfield, Illinois, United States, 62702
Southern Illinois University School of Medicine Active, not recruiting
Springfield, Illinois, United States, 62702
Springfield Clinic Active, not recruiting
Springfield, Illinois, United States, 62702
Memorial Medical Center Active, not recruiting
Springfield, Illinois, United States, 62781
Cancer Care Specialists of Illinois-Swansea Active, not recruiting
Swansea, Illinois, United States, 62226
Memorial and Saint Elizabeth's Health Care Services LLP Active, not recruiting
Swansea, Illinois, United States, 62226
Carle Cancer Center Active, not recruiting
Urbana, Illinois, United States, 61801
The Carle Foundation Hospital Active, not recruiting
Urbana, Illinois, United States, 61801
Northwestern Medicine Cancer Center Warrenville Active, not recruiting
Warrenville, Illinois, United States, 60555
Rush-Copley Healthcare Center Active, not recruiting
Yorkville, Illinois, United States, 60560
United States, Indiana
Franciscan Saint Francis Health-Beech Grove Active, not recruiting
Beech Grove, Indiana, United States, 46107
Indiana University/Melvin and Bren Simon Cancer Center Active, not recruiting
Indianapolis, Indiana, United States, 46202
Franciscan Health Indianapolis Active, not recruiting
Indianapolis, Indiana, United States, 46237
Memorial Regional Cancer Center Day Road Active, not recruiting
Mishawaka, Indiana, United States, 46545
Reid Health Active, not recruiting
Richmond, Indiana, United States, 47374
Memorial Hospital of South Bend Active, not recruiting
South Bend, Indiana, United States, 46601
United States, Iowa
Mary Greeley Medical Center Active, not recruiting
Ames, Iowa, United States, 50010
McFarland Clinic PC-William R Bliss Cancer Center Active, not recruiting
Ames, Iowa, United States, 50010
Constantinou, Costas L MD (UIA Investigator) Active, not recruiting
Bettendorf, Iowa, United States, 52722
University of Iowa Healthcare Cancer Services Quad Cities Active, not recruiting
Bettendorf, Iowa, United States, 52722
McFarland Clinic PC-Boone Active, not recruiting
Boone, Iowa, United States, 50036
Mercy Hospital Active, not recruiting
Cedar Rapids, Iowa, United States, 52403
Oncology Associates at Mercy Medical Center Active, not recruiting
Cedar Rapids, Iowa, United States, 52403
Medical Oncology and Hematology Associates-West Des Moines Active, not recruiting
Clive, Iowa, United States, 50325
Mercy Cancer Center-West Lakes Active, not recruiting
Clive, Iowa, United States, 50325
Alegent Health Mercy Hospital Active, not recruiting
Council Bluffs, Iowa, United States, 51503
Greater Regional Medical Center Active, not recruiting
Creston, Iowa, United States, 50801
Iowa-Wide Oncology Research Coalition NCORP Terminated
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates-Laurel Active, not recruiting
Des Moines, Iowa, United States, 50314
Mercy Medical Center - Des Moines Active, not recruiting
Des Moines, Iowa, United States, 50314
McFarland Clinic PC-Trinity Cancer Center Active, not recruiting
Fort Dodge, Iowa, United States, 50501
McFarland Clinic PC-Jefferson Active, not recruiting
Jefferson, Iowa, United States, 50129
McFarland Clinic PC-Marshalltown Active, not recruiting
Marshalltown, Iowa, United States, 50158
Mercy Medical Center-West Lakes Active, not recruiting
West Des Moines, Iowa, United States, 50266
United States, Kansas
Cancer Center of Kansas - Chanute Active, not recruiting
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City Active, not recruiting
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado Active, not recruiting
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott Active, not recruiting
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas-Independence Active, not recruiting
Independence, Kansas, United States, 67301
Cancer Center of Kansas-Kingman Active, not recruiting
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital Active, not recruiting
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas-Liberal Active, not recruiting
Liberal, Kansas, United States, 67905
Cancer Center of Kansas-Manhattan Active, not recruiting
Manhattan, Kansas, United States, 66502
Cancer Center of Kansas - McPherson Active, not recruiting
McPherson, Kansas, United States, 67460
Cancer Center of Kansas - Newton Active, not recruiting
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Parsons Active, not recruiting
Parsons, Kansas, United States, 67357
Cancer Center of Kansas - Pratt Active, not recruiting
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina Active, not recruiting
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington Active, not recruiting
Wellington, Kansas, United States, 67152
Associates In Womens Health Active, not recruiting
Wichita, Kansas, United States, 67208
Cancer Center of Kansas-Wichita Medical Arts Tower Active, not recruiting
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Wichita Active, not recruiting
Wichita, Kansas, United States, 67214
Via Christi Regional Medical Center Active, not recruiting
Wichita, Kansas, United States, 67214
Wichita NCI Community Oncology Research Program Recruiting
Wichita, Kansas, United States, 67214
Contact: Shaker R. Dakhil    316-268-5374      
Principal Investigator: Shaker R. Dakhil         
Cancer Center of Kansas - Winfield Active, not recruiting
Winfield, Kansas, United States, 67156
United States, Kentucky
Flaget Memorial Hospital Active, not recruiting
Bardstown, Kentucky, United States, 40004
Commonwealth Cancer Center-Corbin Active, not recruiting
Corbin, Kentucky, United States, 40701
Oncology Hematology Care Inc-Crestview Active, not recruiting
Crestview Hills, Kentucky, United States, 41017
Saint Elizabeth Medical Center South Active, not recruiting
Edgewood, Kentucky, United States, 41017
Saint Elizabeth Fort Thomas Active, not recruiting
Fort Thomas, Kentucky, United States, 41075
Saint Joseph Radiation Oncology Resource Center Active, not recruiting
Lexington, Kentucky, United States, 40504
Saint Joseph Hospital East Active, not recruiting
Lexington, Kentucky, United States, 40509
University of Kentucky/Markey Cancer Center Active, not recruiting
Lexington, Kentucky, United States, 40536
Jewish Hospital Active, not recruiting
Louisville, Kentucky, United States, 40202
Saints Mary and Elizabeth Hospital Active, not recruiting
Louisville, Kentucky, United States, 40215
Jewish Hospital Medical Center Northeast Active, not recruiting
Louisville, Kentucky, United States, 40245
Jewish Hospital Medical Center South Active, not recruiting
Shepherdsville, Kentucky, United States, 40165
United States, Louisiana
Ochsner Health Center-Summa Active, not recruiting
Baton Rouge, Louisiana, United States, 70809
Ochsner Baptist Medical Center Active, not recruiting
New Orleans, Louisiana, United States, 70115
Ochsner Medical Center Jefferson Active, not recruiting
New Orleans, Louisiana, United States, 70121
United States, Maine
Central Maine Medical Center Active, not recruiting
Lewiston, Maine, United States, 04240
Saint Mary's Regional Medical Center Active, not recruiting
Lewiston, Maine, United States, 04240
United States, Maryland
Unspecified Site Recruiting
Rockville, Maryland, United States, 20852
Contact: Charles L. Loprinzi    507-284-4849    loprinzi@mayo.edu   
Principal Investigator: Charles L. Loprinzi         
United States, Massachusetts
Massachusetts General Hospital Cancer Center Active, not recruiting
Boston, Massachusetts, United States, 02114
Mass General/North Shore Cancer Center Active, not recruiting
Danvers, Massachusetts, United States, 01923
Newton-Wellesley Hospital Active, not recruiting
Newton, Massachusetts, United States, 02462
United States, Michigan
Bixby Medical Center Active, not recruiting
Adrian, Michigan, United States, 49221
Hickman Cancer Center Active, not recruiting
Adrian, Michigan, United States, 49221
Green Bay Oncology - Escanaba Active, not recruiting
Escanaba, Michigan, United States, 49829
Green Bay Oncology - Iron Mountain Suspended
Iron Mountain, Michigan, United States, 49801
Mercy Memorial Hospital Active, not recruiting
Monroe, Michigan, United States, 48162
Toledo Clinic Cancer Centers-Monroe Active, not recruiting
Monroe, Michigan, United States, 48162
William Beaumont Hospital-Royal Oak Active, not recruiting
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital - Troy Active, not recruiting
Troy, Michigan, United States, 48098
United States, Minnesota
Sanford Clinic North-Bemidgi Active, not recruiting
Bemidji, Minnesota, United States, 56601
Mayo Clinic Health Systems-Mankato Active, not recruiting
Mankato, Minnesota, United States, 56001
Mayo Clinic Active, not recruiting
Rochester, Minnesota, United States, 55905
United States, Missouri
Saint Louis Cancer and Breast Institute-Ballwin Active, not recruiting
Ballwin, Missouri, United States, 63011
Central Care Cancer Center-Carrie J Babb Cancer Center Active, not recruiting
Bolivar, Missouri, United States, 65613
Parkland Health Center-Bonne Terre Active, not recruiting
Bonne Terre, Missouri, United States, 63628
Saint Francis Medical Center Active, not recruiting
Cape Girardeau, Missouri, United States, 63703
Southeast Cancer Center Active, not recruiting
Cape Girardeau, Missouri, United States, 63703
Capital Region Medical Center-Goldschmidt Cancer Center Active, not recruiting
Jefferson City, Missouri, United States, 65109
Freeman Health System Active, not recruiting
Joplin, Missouri, United States, 64804
Mercy Hospital Joplin Active, not recruiting
Joplin, Missouri, United States, 64804
Delbert Day Cancer Institute at PCRMC Active, not recruiting
Rolla, Missouri, United States, 65401
Mercy Clinic-Rolla-Cancer and Hematology Active, not recruiting
Rolla, Missouri, United States, 65401
Saint Louis Cancer and Breast Institute-South City Active, not recruiting
Saint Louis, Missouri, United States, 63109
Washington University School of Medicine Active, not recruiting
Saint Louis, Missouri, United States, 63110
Missouri Baptist Medical Center Active, not recruiting
Saint Louis, Missouri, United States, 63131
Mercy Hospital Saint Louis Active, not recruiting
Saint Louis, Missouri, United States, 63141
Sainte Genevieve County Memorial Hospital Active, not recruiting
Sainte Genevieve, Missouri, United States, 63670
Mercy Hospital Springfield Active, not recruiting
Springfield, Missouri, United States, 65804
CoxHealth South Hospital Active, not recruiting
Springfield, Missouri, United States, 65807
Missouri Baptist Sullivan Hospital Active, not recruiting
Sullivan, Missouri, United States, 63080
Missouri Baptist Outpatient Center-Sunset Hills Active, not recruiting
Sunset Hills, Missouri, United States, 63127
Mercy Hospital Washington Active, not recruiting
Washington, Missouri, United States, 63090
United States, Montana
Community Hospital of Anaconda Active, not recruiting
Anaconda, Montana, United States, 59711
Billings Clinic Cancer Center Active, not recruiting
Billings, Montana, United States, 59101
Saint Vincent Healthcare Active, not recruiting
Billings, Montana, United States, 59101
Montana Cancer Consortium NCORP Recruiting
Billings, Montana, United States, 59102
Contact: Benjamin T. Marchello    800-648-6274      
Principal Investigator: Benjamin T. Marchello         
Saint Vincent Frontier Cancer Center Active, not recruiting
Billings, Montana, United States, 59102
Bozeman Deaconess Hospital Active, not recruiting
Bozeman, Montana, United States, 59715
Saint James Community Hospital and Cancer Treatment Center Active, not recruiting
Butte, Montana, United States, 59701
Benefis Healthcare- Sletten Cancer Institute Active, not recruiting
Great Falls, Montana, United States, 59405
Great Falls Clinic Active, not recruiting
Great Falls, Montana, United States, 59405
Saint Peter's Community Hospital Active, not recruiting
Helena, Montana, United States, 59601
Kalispell Medical Oncology Active, not recruiting
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center Active, not recruiting
Kalispell, Montana, United States, 59901
Montana Cancer Specialists Active, not recruiting
Missoula, Montana, United States, 59802
Saint Patrick Hospital - Community Hospital Active, not recruiting
Missoula, Montana, United States, 59802
Community Medical Hospital Active, not recruiting
Missoula, Montana, United States, 59804
United States, Nebraska
CHI Health Saint Francis Active, not recruiting
Grand Island, Nebraska, United States, 68803
Heartland Hematology and Oncology Active, not recruiting
Kearney, Nebraska, United States, 68845
CHI Health Good Samaritan Active, not recruiting
Kearney, Nebraska, United States, 68847
Saint Elizabeth Regional Medical Center Active, not recruiting
Lincoln, Nebraska, United States, 68510
Nebraska Methodist Hospital Active, not recruiting
Omaha, Nebraska, United States, 68114
Alegent Health Immanuel Medical Center Active, not recruiting
Omaha, Nebraska, United States, 68122
Hematology and Oncology Consultants PC Active, not recruiting
Omaha, Nebraska, United States, 68122
Alegent Health Bergan Mercy Medical Center Active, not recruiting
Omaha, Nebraska, United States, 68124
Alegent Health Lakeside Hospital Active, not recruiting
Omaha, Nebraska, United States, 68130
Creighton University Medical Center Active, not recruiting
Omaha, Nebraska, United States, 68131
University of Nebraska Medical Center Active, not recruiting
Omaha, Nebraska, United States, 68198
Midlands Community Hospital Active, not recruiting
Papillion, Nebraska, United States, 68046
United States, Nevada
Cancer and Blood Specialists-Henderson Active, not recruiting
Henderson, Nevada, United States, 89052
Comprehensive Cancer Centers of Nevada - Henderson Active, not recruiting
Henderson, Nevada, United States, 89052
Las Vegas Cancer Center-Henderson Active, not recruiting
Henderson, Nevada, United States, 89052
21st Century Oncology-Henderson Active, not recruiting
Henderson, Nevada, United States, 89074
Comprehensive Cancer Centers of Nevada-Southeast Henderson Active, not recruiting
Henderson, Nevada, United States, 89074
University Medical Center of Southern Nevada Active, not recruiting
Las Vegas, Nevada, United States, 89102
Cancer and Blood Specialists-Shadow Active, not recruiting
Las Vegas, Nevada, United States, 89106
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John A. Ellerton    702-384-0013      
Principal Investigator: John A. Ellerton         
Radiation Oncology Centers of Nevada Central Active, not recruiting
Las Vegas, Nevada, United States, 89106
21st Century Oncology Active, not recruiting
Las Vegas, Nevada, United States, 89109
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway Active, not recruiting
Las Vegas, Nevada, United States, 89109
HealthCare Partners Medical Group Oncology/Hematology-San Martin Active, not recruiting
Las Vegas, Nevada, United States, 89113
Radiation Oncology Centers of Nevada Southeast Active, not recruiting
Las Vegas, Nevada, United States, 89119
Cancer Therapy and Integrative Medicine Active, not recruiting
Las Vegas, Nevada, United States, 89121
21st Century Oncology-Vegas Tenaya Active, not recruiting
Las Vegas, Nevada, United States, 89128
Cancer and Blood Specialists-Tenaya Active, not recruiting
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada - Northwest Active, not recruiting
Las Vegas, Nevada, United States, 89128
HealthCare Partners Medical Group Oncology/Hematology-Tenaya Active, not recruiting
Las Vegas, Nevada, United States, 89128
Comprehensive Cancer Centers of Nevada-Summerlin Active, not recruiting
Las Vegas, Nevada, United States, 89144
Las Vegas Cancer Center-Medical Center Active, not recruiting
Las Vegas, Nevada, United States, 89148-2405
21st Century Oncology-Fort Apache Active, not recruiting
Las Vegas, Nevada, United States, 89148
Comprehensive Cancer Centers of Nevada Active, not recruiting
Las Vegas, Nevada, United States, 89148
Nevada Cancer Specialists-Fort Apache Active, not recruiting
Las Vegas, Nevada, United States, 89148
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills Active, not recruiting
Las Vegas, Nevada, United States, 89149
Comprehensive Cancer Centers of Nevada - Central Valley Active, not recruiting
Las Vegas, Nevada, United States, 89169
United States, New Hampshire
New Hampshire Oncology Hematology PA-Concord Active, not recruiting
Concord, New Hampshire, United States, 03301
New Hampshire Oncology Hematology PA-Hooksett Active, not recruiting
Hooksett, New Hampshire, United States, 03106
LRGHealthcare-Lakes Region General Hospital Active, not recruiting
Laconia, New Hampshire, United States, 03246
The Dana-Farber Cancer Institute at Londonderry Active, not recruiting
Londonderry, New Hampshire, United States, 03053
United States, New Jersey
Cooper Hospital University Medical Center Active, not recruiting
Camden, New Jersey, United States, 08103
Englewood Hospital and Medical Center Active, not recruiting
Englewood, New Jersey, United States, 07631
Virtua Memorial Active, not recruiting
Mount Holly, New Jersey, United States, 08060
Inspira Medical Center Vineland Active, not recruiting
Vineland, New Jersey, United States, 08360
Virtua Voorhees Active, not recruiting
Voorhees, New Jersey, United States, 08043
Inspira Medical Center Woodbury Active, not recruiting
Woodbury, New Jersey, United States, 08096
United States, New York
Glens Falls Hospital Active, not recruiting
Glens Falls, New York, United States, 12801
Orange Regional Medical Center Active, not recruiting
Middletown, New York, United States, 10940
United States, North Carolina
Gaston Hematology and Oncology Associates-Belmont Active, not recruiting
Belmont, North Carolina, United States, 28012
Cone Health Cancer Center at Alamance Regional Active, not recruiting
Burlington, North Carolina, United States, 27215
Novant Health Presbyterian Medical Center Active, not recruiting
Charlotte, North Carolina, United States, 28204
Carolina Surgical Clinic of Charlotte PA Active, not recruiting
Charlotte, North Carolina, United States, 28207
Oncology Specialists of Charlotte Active, not recruiting
Charlotte, North Carolina, United States, 28207
Southern Oncology Specialists-Charlotte Active, not recruiting
Charlotte, North Carolina, United States, 28262
Southeastern Medical Oncology Center-Clinton Active, not recruiting
Clinton, North Carolina, United States, 28328
CaroMont Regional Medical Center Active, not recruiting
Gastonia, North Carolina, United States, 28054
Gaston Hematology and Oncology Associates Active, not recruiting
Gastonia, North Carolina, United States, 28054
Southeastern Medical Oncology Center-Goldsboro Active, not recruiting
Goldsboro, North Carolina, United States, 27534
Wayne Memorial Hospital Active, not recruiting
Goldsboro, North Carolina, United States, 27534
Lake Norman Hematology Oncology Specialists-Huntersville Active, not recruiting
Huntersville, North Carolina, United States, 28078
Southern Oncology Specialists-Huntersville Active, not recruiting
Huntersville, North Carolina, United States, 28078
Southeastern Medical Oncology Center-Jacksonville Active, not recruiting
Jacksonville, North Carolina, United States, 28546
Kinston Medical Specialists PA Active, not recruiting
Kinston, North Carolina, United States, 28501
Matthews Radiation Oncology Center Active, not recruiting
Matthews, North Carolina, United States, 28105
Novant Health Cancer Specialists-Matthews Active, not recruiting
Matthews, North Carolina, United States, 28105
Lake Norman Hematology Oncology Specialists-Mooresville Active, not recruiting
Mooresville, North Carolina, United States, 28117
Southeastern Medical Oncology Center-Wilson Active, not recruiting
Wilson, North Carolina, United States, 27893
United States, North Dakota
Sanford Bismarck Medical Center Active, not recruiting
Bismarck, North Dakota, United States, 58501
Roger Maris Cancer Center Active, not recruiting
Fargo, North Dakota, United States, 58122
Sanford Broadway Medical Center Active, not recruiting
Fargo, North Dakota, United States, 58122
Sanford Clinic North-Fargo Recruiting
Fargo, North Dakota, United States, 58122
Contact: Preston D. Steen    712-252-0088      
Principal Investigator: Preston D. Steen         
Altru Cancer Center Active, not recruiting
Grand Forks, North Dakota, United States, 58201
Trinity Cancer Care Center Active, not recruiting
Minot, North Dakota, United States, 58701
United States, Ohio
Akron General Medical Center Active, not recruiting
Akron, Ohio, United States, 44307
Toledo Clinic Cancer Centers-Bowling Green Active, not recruiting
Bowling Green, Ohio, United States, 43402
Dayton Physicians LLC-Miami Valley South Active, not recruiting
Centerville, Ohio, United States, 45459
Miami Valley Hospital South Active, not recruiting
Centerville, Ohio, United States, 45459
Oncology Hematology Care Inc-Eden Park Active, not recruiting
Cincinnati, Ohio, United States, 45202
Oncology Hematology Care Inc-Mercy West Active, not recruiting
Cincinnati, Ohio, United States, 45211
University of Cincinnati/Barrett Cancer Center Active, not recruiting
Cincinnati, Ohio, United States, 45219
Good Samaritan Hospital - Cincinnati Active, not recruiting
Cincinnati, Ohio, United States, 45220
Oncology Hematology Care Inc - Anderson Active, not recruiting
Cincinnati, Ohio, United States, 45230
Oncology Hematology Care Inc-Kenwood Active, not recruiting
Cincinnati, Ohio, United States, 45236
Bethesda North Hospital Active, not recruiting
Cincinnati, Ohio, United States, 45242
Oncology Hematology Care Inc-Blue Ash Active, not recruiting
Cincinnati, Ohio, United States, 45242
TriHealth Cancer Institute-Westside Active, not recruiting
Cincinnati, Ohio, United States, 45247
TriHealth Cancer Institute-Anderson Active, not recruiting
Cincinnati, Ohio, United States, 45255
Grandview Hospital Active, not recruiting
Dayton, Ohio, United States, 45405
Good Samaritan Hospital - Dayton Active, not recruiting
Dayton, Ohio, United States, 45406
Miami Valley Hospital Active, not recruiting
Dayton, Ohio, United States, 45409
Dayton Physicians LLC-Samaritan North Active, not recruiting
Dayton, Ohio, United States, 45415
Samaritan North Health Center Active, not recruiting
Dayton, Ohio, United States, 45415
Dayton NCI Community Oncology Research Program Terminated
Dayton, Ohio, United States, 45420
Hematology Oncology Center Incorporated Active, not recruiting
Elyria, Ohio, United States, 44035
Mercy Cancer Center-Elyria Active, not recruiting
Elyria, Ohio, United States, 44035
Oncology Hematology Care Inc-Healthplex Active, not recruiting
Fairfield, Ohio, United States, 45014
Armes Family Cancer Center Active, not recruiting
Findlay, Ohio, United States, 45840
Blanchard Valley Hospital Active, not recruiting
Findlay, Ohio, United States, 45840
Orion Cancer Care Active, not recruiting
Findlay, Ohio, United States, 45840
Atrium Medical Center-Middletown Regional Hospital Active, not recruiting
Franklin, Ohio, United States, 45005-1066
Dayton Physicians LLC-Atrium Active, not recruiting
Franklin, Ohio, United States, 45005
Dayton Physicians LLC-Wayne Active, not recruiting
Greenville, Ohio, United States, 45331
Wayne Hospital Active, not recruiting
Greenville, Ohio, United States, 45331
Greater Dayton Cancer Center Active, not recruiting
Kettering, Ohio, United States, 45409
Kettering Medical Center Active, not recruiting
Kettering, Ohio, United States, 45429
Lima Memorial Hospital Active, not recruiting
Lima, Ohio, United States, 45804
Toledo Clinic Cancer Centers-Maumee Active, not recruiting
Maumee, Ohio, United States, 43537
Toledo Radiation Oncology at Northwest Ohio Onocolgy Center Active, not recruiting
Maumee, Ohio, United States, 43537
Dayton Physicians LLC-Signal Point Active, not recruiting
Middletown, Ohio, United States, 45042
Saint Charles Hospital Active, not recruiting
Oregon, Ohio, United States, 43616
Toledo Clinic Cancer Centers-Oregon Active, not recruiting
Oregon, Ohio, United States, 43616
Dayton Physicians LLC-Wilson Active, not recruiting
Sidney, Ohio, United States, 45365
Springfield Regional Cancer Center Active, not recruiting
Springfield, Ohio, United States, 45504
Springfield Regional Medical Center Active, not recruiting
Springfield, Ohio, United States, 45505
Flower Hospital Active, not recruiting
Sylvania, Ohio, United States, 43560
Mercy Hospital of Tiffin Active, not recruiting
Tiffin, Ohio, United States, 44883
The Toledo Hospital/Toledo Children's Hospital Active, not recruiting
Toledo, Ohio, United States, 43606
Saint Vincent Mercy Medical Center Active, not recruiting
Toledo, Ohio, United States, 43608
University of Toledo Active, not recruiting
Toledo, Ohio, United States, 43614
Toledo Community Hospital Oncology Program CCOP Active, not recruiting
Toledo, Ohio, United States, 43617
Mercy Saint Anne Hospital Active, not recruiting
Toledo, Ohio, United States, 43623
Toledo Clinic Cancer Centers-Toledo Active, not recruiting
Toledo, Ohio, United States, 43623
Dayton Physicians LLC-Upper Valley Active, not recruiting
Troy, Ohio, United States, 45373
Upper Valley Medical Center Active, not recruiting
Troy, Ohio, United States, 45373
Fulton County Health Center Active, not recruiting
Wauseon, Ohio, United States, 43567
University Pointe Active, not recruiting
West Chester, Ohio, United States, 45069
Wright-Patterson Medical Center Active, not recruiting
Wright-Patterson Air Force Base, Ohio, United States, 45433-5529
Greene Memorial Hospital Active, not recruiting
Xenia, Ohio, United States, 45385
United States, Oklahoma
University of Oklahoma Health Sciences Center Active, not recruiting
Oklahoma City, Oklahoma, United States, 73104
Oklahoma Cancer Specialists and Research Institute-Tulsa Active, not recruiting
Tulsa, Oklahoma, United States, 74146
United States, Oregon
Saint Charles Health System Active, not recruiting
Bend, Oregon, United States, 97701
Clackamas Radiation Oncology Center Active, not recruiting
Clackamas, Oregon, United States, 97015
Providence Oncology and Hematology Care Southeast Active, not recruiting
Clackamas, Oregon, United States, 97015
Bay Area Hospital Active, not recruiting
Coos Bay, Oregon, United States, 97420
Providence Newberg Medical Center Active, not recruiting
Newberg, Oregon, United States, 97132
Providence Willamette Falls Medical Center Active, not recruiting
Oregon City, Oregon, United States, 97045
Providence Portland Medical Center Active, not recruiting
Portland, Oregon, United States, 97213
Providence Saint Vincent Medical Center Active, not recruiting
Portland, Oregon, United States, 97225
United States, Pennsylvania
Guthrie Medical Group PC-Robert Packer Hospital Active, not recruiting
Sayre, Pennsylvania, United States, 18840
UPMC Susquehanna Active, not recruiting
Williamsport, Pennsylvania, United States, 17701
United States, South Carolina
Roper Hospital Active, not recruiting
Charleston, South Carolina, United States, 29401
Charleston Hematology Oncology Associates-Roper Active, not recruiting
Charleston, South Carolina, United States, 29403
Lowcountry Hematology Oncology PA-North Charleston Active, not recruiting
Charleston, South Carolina, United States, 29406
Bon Secours Saint Francis Hospital Active, not recruiting
Charleston, South Carolina, United States, 29414
Charleston Hematology Oncology Associates PA-Saint Francis Active, not recruiting
Charleston, South Carolina, United States, 29414
Lowcountry Hematology Oncology PA-West Ashley Active, not recruiting
Charleston, South Carolina, United States, 29414
Greenville Health System Cancer Institute-Easley Active, not recruiting
Easley, South Carolina, United States, 29640
Greenville Health System Cancer Institute-Andrews Active, not recruiting
Greenville, South Carolina, United States, 29601
Greenville Health System Cancer Institute-Butternut Active, not recruiting
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Faris Active, not recruiting
Greenville, South Carolina, United States, 29605
Greenville Memorial Hospital Active, not recruiting
Greenville, South Carolina, United States, 29605
Greenville Health System Cancer Institute-Eastside Active, not recruiting
Greenville, South Carolina, United States, 29615
Greenville Health System Cancer Institute-Greer Active, not recruiting
Greer, South Carolina, United States, 29650
Lowcountry Hematology Oncology PA-Mount Pleasant Active, not recruiting
Mount Pleasant, South Carolina, United States, 29464
Greenville Health System Cancer Institute-Seneca Active, not recruiting
Seneca, South Carolina, United States, 29672
Greenville Health System Cancer Institute-Spartanburg Active, not recruiting
Spartanburg, South Carolina, United States, 29307
United States, South Dakota
Avera Cancer Institute-Aberdeen Active, not recruiting
Aberdeen, South Dakota, United States, 57401
Sanford Cancer Center Oncology Clinic Active, not recruiting
Sioux Falls, South Dakota, United States, 57104
Sanford USD Medical Center - Sioux Falls Active, not recruiting
Sioux Falls, South Dakota, United States, 57117-5134
United States, Tennessee
Wellmont Bristol Regional Medical Center Active, not recruiting
Bristol, Tennessee, United States, 37620
Wellmont Medical Associates Oncology and Hematology-Bristol Active, not recruiting
Bristol, Tennessee, United States, 37620
Memorial Hospital Active, not recruiting
Chattanooga, Tennessee, United States, 37404
Pulmonary Medicine Center of Chattanooga-Hixson Active, not recruiting
Hixson, Tennessee, United States, 37343
Jackson-Madison County General Hospital Active, not recruiting
Jackson, Tennessee, United States, 38301
Wellmont Medical Associates Oncology and Hematology-Johnson City Active, not recruiting
Johnson City, Tennessee, United States, 37604
Wellmont Holston Valley Hospital and Medical Center Active, not recruiting
Kingsport, Tennessee, United States, 37660
Wellmont Medical Associates Oncology and Hematology-Kingsport Active, not recruiting
Kingsport, Tennessee, United States, 37660
University of Tennessee - Knoxville Active, not recruiting
Knoxville, Tennessee, United States, 37920
Nashville Breast Center Active, not recruiting
Nashville, Tennessee, United States, 37203
Meharry Medical College Active, not recruiting
Nashville, Tennessee, United States, 37208
Memorial GYN Plus Active, not recruiting
Ooltewah, Tennessee, United States, 37363
United States, Texas
Saint Joseph Regional Cancer Center Active, not recruiting
Bryan, Texas, United States, 77802
Doctor's Hospital of Laredo Active, not recruiting
Laredo, Texas, United States, 78041
United States, Utah
Huntsman Cancer Institute/University of Utah Active, not recruiting
Salt Lake City, Utah, United States, 84112
South Jordan Health Center Active, not recruiting
South Jordan, Utah, United States, 84009
United States, Virginia
IMG Hematology Oncology 8501 Active, not recruiting
Fairfax, Virginia, United States, 22031
Inova Fair Oaks Hospital Active, not recruiting
Fairfax, Virginia, United States, 22033
Fredericksburg Oncology Inc Active, not recruiting
Fredericksburg, Virginia, United States, 22401
Sovah Health Martinsville Active, not recruiting
Martinsville, Virginia, United States, 24115
Southwest VA Regional Cancer Center Active, not recruiting
Norton, Virginia, United States, 24273
United States, Washington
Providence Regional Cancer System-Aberdeen Active, not recruiting
Aberdeen, Washington, United States, 98520
Cancer Care Center at Island Hospital Active, not recruiting
Anacortes, Washington, United States, 98221
PeaceHealth Saint Joseph Medical Center Active, not recruiting
Bellingham, Washington, United States, 98225
Harrison HealthPartners Hematology and Oncology-Bremerton Active, not recruiting
Bremerton, Washington, United States, 98310
Harrison Medical Center Active, not recruiting
Bremerton, Washington, United States, 98310
Highline Medical Center-Main Campus Active, not recruiting
Burien, Washington, United States, 98166
Providence Regional Cancer System-Centralia Active, not recruiting
Centralia, Washington, United States, 98531
Swedish Medical Center-Edmonds Active, not recruiting
Edmonds, Washington, United States, 98026
Saint Elizabeth Hospital Active, not recruiting
Enumclaw, Washington, United States, 98022
Providence Regional Cancer Partnership Active, not recruiting
Everett, Washington, United States, 98201
Saint Francis Hospital Active, not recruiting
Federal Way, Washington, United States, 98003
Swedish Cancer Institute-Issaquah Active, not recruiting
Issaquah, Washington, United States, 98029
Kadlec Clinic Hematology and Oncology Active, not recruiting
Kennewick, Washington, United States, 99336
Providence Regional Cancer System-Lacey Active, not recruiting
Lacey, Washington, United States, 98503
Saint Clare Hospital Active, not recruiting
Lakewood, Washington, United States, 98499
PeaceHealth Saint John Medical Center Active, not recruiting
Longview, Washington, United States, 98632
Harrison HealthPartners Hematology and Oncology-Poulsbo Active, not recruiting
Poulsbo, Washington, United States, 98370
Pacific Gynecology Specialists Active, not recruiting
Seattle, Washington, United States, 98104
Swedish Medical Center-Ballard Campus Active, not recruiting
Seattle, Washington, United States, 98107
Kaiser Permanente Washington Active, not recruiting
Seattle, Washington, United States, 98112
Swedish Medical Center-First Hill Active, not recruiting
Seattle, Washington, United States, 98122-4307
Swedish Medical Center-Cherry Hill Active, not recruiting
Seattle, Washington, United States, 98122-5711
Providence Regional Cancer System-Shelton Active, not recruiting
Shelton, Washington, United States, 98584
Rockwood Clinic Cancer Treatment Center-Valley Active, not recruiting
Spokane Valley, Washington, United States, 99216
Rockwood Cancer Treatment Center-DHEC-Downtown Active, not recruiting
Spokane, Washington, United States, 99204
Rockwood North Cancer Treatment Center Active, not recruiting
Spokane, Washington, United States, 99218
Franciscan Research Center-Northwest Medical Plaza Active, not recruiting
Tacoma, Washington, United States, 98405
Northwest Medical Specialties PLLC Active, not recruiting
Tacoma, Washington, United States, 98405
PeaceHealth Southwest Medical Center Active, not recruiting
Vancouver, Washington, United States, 98664
Providence Saint Mary Regional Cancer Center Active, not recruiting
Walla Walla, Washington, United States, 99362
Providence Regional Cancer System-Yelm Active, not recruiting
Yelm, Washington, United States, 98597
United States, Wisconsin
ThedaCare Regional Cancer Center Active, not recruiting
Appleton, Wisconsin, United States, 54911
Aurora Cancer Care-Southern Lakes VLCC Active, not recruiting
Burlington, Wisconsin, United States, 53105
Marshfield Clinic Cancer Center - Eau Claire Active, not recruiting
Eau Claire, Wisconsin, United States, 54701
Marshfield Clinic Cancer Center at Sacred Heart Active, not recruiting
Eau Claire, Wisconsin, United States, 54701
Aurora Health Center-Fond du Lac Active, not recruiting
Fond Du Lac, Wisconsin, United States, 54937
Aurora Health Care Germantown Health Center Active, not recruiting
Germantown, Wisconsin, United States, 53022
Aurora Cancer Care-Grafton Active, not recruiting
Grafton, Wisconsin, United States, 53024
Green Bay Oncology at Saint Vincent Hospital Suspended
Green Bay, Wisconsin, United States, 54301-3526
Saint Vincent Hospital Cancer Center Green Bay Active, not recruiting
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital Suspended
Green Bay, Wisconsin, United States, 54303
Saint Vincent Hospital Cancer Center at Saint Mary's Active, not recruiting
Green Bay, Wisconsin, United States, 54303
Aurora BayCare Medical Center Active, not recruiting
Green Bay, Wisconsin, United States, 54311
Aurora Cancer Care-Kenosha South Active, not recruiting
Kenosha, Wisconsin, United States, 53142
Gundersen Lutheran Medical Center Active, not recruiting
La Crosse, Wisconsin, United States, 54601
Mayo Clinic Health System-Franciscan Healthcare Active, not recruiting
La Crosse, Wisconsin, United States, 54601
Dean Hematology and Oncology Clinic Active, not recruiting
Madison, Wisconsin, United States, 53717
Holy Family Memorial Hospital Active, not recruiting
Manitowoc, Wisconsin, United States, 54221
Aurora Bay Area Medical Group-Marinette Active, not recruiting
Marinette, Wisconsin, United States, 54143
Bay Area Medical Center Active, not recruiting
Marinette, Wisconsin, United States, 54143
Vince Lombardi Cancer Clinic-Marinette Active, not recruiting
Marinette, Wisconsin, United States, 54143
Marshfield Clinic Active, not recruiting
Marshfield, Wisconsin, United States, 54449
Aurora Cancer Care-Milwaukee Active, not recruiting
Milwaukee, Wisconsin, United States, 53209
Aurora Saint Luke's Medical Center Active, not recruiting
Milwaukee, Wisconsin, United States, 53215
Aurora Sinai Medical Center Active, not recruiting
Milwaukee, Wisconsin, United States, 53233
Marshfield Clinic-Minocqua Center Active, not recruiting
Minocqua, Wisconsin, United States, 54548
Green Bay Oncology - Oconto Falls Active, not recruiting
Oconto Falls, Wisconsin, United States, 54154
Vince Lombardi Cancer Clinic - Oshkosh Active, not recruiting
Oshkosh, Wisconsin, United States, 54904
Aurora Cancer Care-Racine Active, not recruiting
Racine, Wisconsin, United States, 53406
Ascension Saint Mary's Hospital Active, not recruiting
Rhinelander, Wisconsin, United States, 54501
Marshfield Clinic-Rice Lake Center Active, not recruiting
Rice Lake, Wisconsin, United States, 54868
HSHS Saint Nicholas Hospital Active, not recruiting
Sheboygan, Wisconsin, United States, 53081
Vince Lombardi Cancer Clinic-Sheboygan Active, not recruiting
Sheboygan, Wisconsin, United States, 53081
Ascension Saint Michael's Hospital Active, not recruiting
Stevens Point, Wisconsin, United States, 54481
Saint Vincent Hospital Cancer Center at Sturgeon Bay Active, not recruiting
Sturgeon Bay, Wisconsin, United States, 54235-1495
Green Bay Oncology - Sturgeon Bay Suspended
Sturgeon Bay, Wisconsin, United States, 54235
Aurora Medical Center in Summit Active, not recruiting
Summit, Wisconsin, United States, 53066
Vince Lombardi Cancer Clinic-Two Rivers Active, not recruiting
Two Rivers, Wisconsin, United States, 54241
Aurora Cancer Care-Waukesha Active, not recruiting
Waukesha, Wisconsin, United States, 53188
Marshfield Clinic-Wausau Center Active, not recruiting
Wausau, Wisconsin, United States, 54401
Aurora Cancer Care-Milwaukee West Active, not recruiting
Wauwatosa, Wisconsin, United States, 53226
Aurora West Allis Medical Center Active, not recruiting
West Allis, Wisconsin, United States, 53227
Marshfield Clinic - Weston Center Active, not recruiting
Weston, Wisconsin, United States, 54476
Marshfield Clinic - Wisconsin Rapids Center Active, not recruiting
Wisconsin Rapids, Wisconsin, United States, 54494
United States, Wyoming
Rocky Mountain Oncology Active, not recruiting
Casper, Wyoming, United States, 82609
Cheyenne Regional Medical Center-West Active, not recruiting
Cheyenne, Wyoming, United States, 82001
Big Horn Basin Cancer Center Active, not recruiting
Cody, Wyoming, United States, 82414
Billings Clinic-Cody Active, not recruiting
Cody, Wyoming, United States, 82414
Welch Cancer Center Active, not recruiting
Sheridan, Wyoming, United States, 82801
Puerto Rico
San Juan City Hospital Active, not recruiting
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Charles Loprinzi, MD Mayo Clinic

Additional Information:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01573442     History of Changes
Other Study ID Numbers: A221102
CDR0000730083 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2012-00719 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
U10CA037447 ( U.S. NIH Grant/Contract )
UG1CA189823 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2012    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

Keywords provided by Alliance for Clinical Trials in Oncology:
hot flashes
musculoskeletal complications
sexual dysfunction
estrogen receptor-positive breast cancer
progesterone receptor-positive breast cancer
arthralgia
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Hot Flashes
Arthralgia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Aromatase Inhibitors
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists