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

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, Supportive care, TreatmentActive18 and overNCI, OtherA221102
CDR0000730083, NCI-2012-00719, U10CA037447, CALGB-A221102, NCCTG-N10C7, NCT01573442

Trial Description

Summary

RATIONALE: Testosterone may help relieve moderate or severe arthralgia associated with the use of aromatase inhibitors, such as anastrozole or letrozole.

PURPOSE: This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia caused by anastrozole or letrozole.

Further Study Information

OUTLINE:

This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. Patients receive testosterone transdermally on day 1 and then at 3 months on Arm I. Patients receive placebo transdermally on day 1 and then at 3 months on Arm II. The primary objective of the study is to determine whether testosterone will reduce aromatase inhibitor (AI)-induced arthralgia and associated joint symptoms. The secondary objective of the study 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. After completion of study treatment, patients are followed up for 6 months.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Women who have undergone a total mastectomy or breast-conserving surgery for primary breast cancer +/-chemotherapy and +/-radiotherapy
  • Receiving anastrozole (1 mg) or letrozole (2.5 mg) orally once a day, for ≥ 21 days prior to registration
  • Must have BOTH estrogen receptor-positive (ER+) and progesterone receptor-positive (PR+) tumors and BOTH must be ≥ 30% positive
  • ≥ 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 measured by verbally addressing the following question: "Please rate your pain by picking a number, from 0 to 10 (0 being none and 10 being as bad as you can imagine) that best describes your pain from your aromatase inhibitor breast cancer medication on AVERAGE, over the past week."
  • No presence of residual or recurrent cancer (locally or metastatic)

PATIENT CHARACTERISTICS:

  • Body Mass Index (BMI) between 18 and 32 kg/m²
  • Women who are postmenopausal by surgery, radiotherapy, or presence of natural amenorrhea ≥ 12 months
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) ≤ 1.5 times upper limit of normal (ULN)
  • ECOG Performance Status (PS) 0, 1, or 2
  • Serum creatinine ≤1.5 times ULN
  • Hemoglobin > 11 g/dL
  • White blood cell (WBC) > 3,000/mm³
  • Platelets > 100,000/mm³
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Willing to provide informed written consent
  • Willing to return to an Alliance enrolling institution for follow-up
  • Willing to provide blood samples for correlative research purposes
  • No diabetes mellitus or glucose intolerance, defined as a fasting glucose > 125 mg/dL
  • No history of coronary artery disease (angina or myocardial infarction)
  • No known hypersensitivity to any component of testosterone
  • No history of a deep venous thrombosis or a thromboembolism

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No patients on hormone-replacement therapy (HRT) ≤ 4 weeks before prior to registration
  • No prolonged systemic corticosteroid treatment, except for topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airway diseases), eye drops, or local injections (e.g., intra-articular)
  • Short duration (< 2 weeks) of systemic corticosteroids is allowed (e.g., for chronic obstructive pulmonary disease), but not within 30 days prior to registration
  • Not receiving any other investigational agent
  • No concurrent use of the aromatase inhibitor exemestane
  • No concurrent radiation therapy or chemotherapy
  • No current or planned use of cyclosporine, anticoagulants, oxyphenbutazone, insulin, oral or injectable vitamin D doses over 4,000 IU/day or tamoxifen

Trial Contact Information

Trial Lead Organizations/Sponsors

Alliance for Clinical Trials in Oncology

National Cancer Institute

Charles L. LoprinziPrincipal Investigator

Trial Sites

U.S.A.
California
  Berkeley
 Alta Bates Summit Comprehensive Cancer Center
 Ari D Baron Ph: 415-600-1182
  Email: SchmidtJ@cpmcri.org
  Burlingame
 Peninsula Medical Center
 Ari D Baron Ph: 415-600-1182
  Email: SchmidtJ@cpmcri.org
  Los Angeles
 Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center
 Armando E Giuliano Ph: 310-423-8965
  Novato
 Sutter Health Western Division Cancer Research Group
 Ari D Baron Ph: 415-600-1182
  Email: SchmidtJ@cpmcri.org
  Palo Alto
 Palo Alto Medical Foundation
 David S Leibowitz Ph: 650-853-5757
  Email: hilld@pamf.org
  San Francisco
 California Pacific Medical Center - California Campus
 Ari D Baron Ph: 415-600-1182
  Email: SchmidtJ@cpmcri.org
  Santa Rosa
 Sutter Pacific Medical Foundation
 Ari D Baron Ph: 415-600-1182
  Email: SchmidtJ@cpmcri.org
  Sunnyvale
 Palo Atlo Medical Foundation-Sunnyvale
 Peter P. Yu Ph: 408-730-2800
  Vallejo
 Sutter Solano Medical Center
 Ari D Baron Ph: 415-600-1182
  Email: SchmidtJ@cpmcri.org
Colorado
  Aurora
 Medical Center of Aurora - South Campus
 Keren Sturtz Ph: 888-785-6789
  Boulder
 Boulder Community Hospital
 Keren Sturtz Ph: 888-785-6789
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Keren Sturtz Ph: 888-785-6789
  Denver
 CCOP - Colorado Cancer Research Program
 Keren Sturtz Ph: 888-785-6789
 Porter Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
 Presbyterian - St. Luke's Medical Center
 Keren Sturtz Ph: 888-785-6789
 Rose Medical Center
 Keren Sturtz Ph: 888-785-6789
 St. Joseph Hospital
 Keren Sturtz Ph: 888-785-6789
  Englewood
 Swedish Medical Center
 Keren Sturtz Ph: 888-785-6789
  Greeley
 North Colorado Medical Center
 Keren Sturtz Ph: 888-785-6789
  Lakewood
 St. Anthony Central Hospital
 Keren Sturtz Ph: 888-785-6789
  Littleton
 Littleton Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
  Lone Tree
 Sky Ridge Medical Center
 Keren Sturtz Ph: 888-785-6789
  Longmont
 Hope Cancer Care Center at Longmont United Hospital
 Keren Sturtz Ph: 888-785-6789
  Loveland
 McKee Medical Center
 Keren Sturtz Ph: 888-785-6789
  Parker
 Parker Adventist Hospital
 Keren Sturtz Ph: 888-785-6789
  Pueblo
 St. Mary - Corwin Regional Medical Center
 Keren Sturtz Ph: 888-785-6789
  Wheat Ridge
 Exempla Lutheran Medical Center
 Keren Sturtz Ph: 888-785-6789
Delaware
  Lewes
 Tunnell Cancer Center at Beebe Medical Center
 Stephen Scott Grubbs Ph: 302-733-6227
  Newark
 Helen F. Graham Cancer Center at Christiana Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
  Seaford
 Nanticoke Memorial Hospital
 Stephen Scott Grubbs Ph: 302-733-6227
District of Columbia
  Washington
 Washington Cancer Institute at Washington Hospital Center
 Sandra M Swain Ph: 202-877-8839
Florida
  Lakeland
 Lakeland Regional Cancer Center at Lakeland Regional Medical Center
 Madhavi L. Venigalla Ph: 863-904-1900
  Orlando
 Florida Hospital Cancer Institute at Florida Hospital Orlando
 Lee M. Zehngebot Ph: 407-303-5623
Georgia
  Columbus
 John B. Amos Cancer Center
 Andrew W. Pippas Ph: 706-660-6404
Idaho
  Post Falls
 Kootenai Cancer Center - Post Falls
 Benjamin Thomas Marchello Ph: 800-648-6274
Illinois
  Harvey
 Ingalls Cancer Care Center at Ingalls Memorial Hospital
 Mark F. Kozloff Ph: 708-915-4673
  Email: clinicaltrials@ingalls.org
  La Grange
 La Grange Memorial Hospital
 James E. Hannigan Ph: 800-323-8622
  Moline
 Garneau, Stewart C MD (UIA Investigator)
 Costas L. Constantinou Ph: 319-363-2690
 Porubcin, Michael MD (UIA Investigator)
 David M Spector Ph: 309-779-4200
 Spector, David MD (UIA Investigator)
 David M Spector Ph: 309-779-4200
 Trinity Cancer Center at Trinity Medical Center - 7th Street Campus
 David M Spector Ph: 309-779-4200
Indiana
  Beech Grove
 St. Francis Hospital and Health Centers - Beech Grove Campus
 Howard M. Gross Ph: 765-983-3000
  Indianapolis
 Indiana University Melvin and Bren Simon Cancer Center
 Kathy Miller Ph: 317-274-2552
 St. Francis Hospital Cancer Care Services
 Howard M. Gross Ph: 765-983-3000
  Richmond
 Reid Hospital & Health Care Services
 Howard M. Gross Ph: 765-983-3000
Iowa
  Ames
 McFarland Clinic, PC
 Joseph James Merchant Ph: 515-239-2621
  Bettendorf
 Constantinou, Costas L MD (UIA Investigator)
 David M Spector Ph: 309-779-4200
Kentucky
  Edgewood
 St. Elizabeth Medical Center
 Joseph Michael Guenther Ph: 859-301-5473
  Email: darla.hehman@stelizabeth.com
  Fort Thomas
 St. Luke Hospital East
 Joseph Michael Guenther Ph: 859-301-5473
  Email: darla.hehman@stelizabeth.com
  Lexington
 University of Kentucky Chandler Medical Center
 Mara D Chambers Ph: 859-257-3379
Louisiana
  Baton Rouge
 Ochsner Health Center - Bluebonnet
 John T Cole Ph: 888-562-4763
  New Orleans
 New Orleans Cancer Institute at Memorial Medical Center
 John T Cole Ph: 888-562-4763
 Ochsner Cancer Institute at Ochsner Clinic Foundation
 John T Cole Ph: 888-562-4763
Massachusetts
  Boston
 Massachusetts General Hospital
 Beverly Moy Ph: 877-726-5130
  Newton
 Newton-Wellesley Hospital
 Beverly Moy Ph: 877-726-5130
Michigan
  Escanaba
 Green Bay Oncology, Limited - Escanaba
 Anthony J. Jaslowski Ph: 800-432-6049
  Iron Mountain
 Green Bay Oncology - Iron Mountain
 Anthony J. Jaslowski Ph: 800-432-6049
Minnesota
  Bemidji
 MeritCare Bemidji
 Preston D. Steen Ph: 701-234-6161
  Mankato
 Immanuel St. Joseph's
 Mohmmad J Ranginwala Ph: 507-385-2929
  Rochester
 Mayo Clinic Cancer Center
 Charles L. Loprinzi Ph: 507-538-7623
Missouri
  Saint Louis
 Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
 Rebecca L Aft Ph: 800-600-3606
  Email: info@siteman.wustl.edu
Montana
  Billings
 Billings Clinic Cancer Center - 801 N 29th Street
 Benjamin Thomas Marchello Ph: 800-648-6274
 CCOP - Montana Cancer Consortium
 Benjamin Thomas Marchello Ph: 800-648-6274
 St. Vincent Healthcare Cancer Care Services
 Benjamin Thomas Marchello Ph: 800-648-6274
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Butte
 St. James Healthcare Cancer Care
 Benjamin Thomas Marchello Ph: 800-648-6274
  Great Falls
 Benefis Sletten Cancer Institute
 Benjamin Thomas Marchello Ph: 800-648-6274
  Helena
 St. Peter's Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274
  Kalispell
 Kalispell Regional Medical Center
 Benjamin Thomas Marchello Ph: 800-648-6274
  Missoula
 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
 Benjamin Thomas Marchello Ph: 800-648-6274
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 John Allan Ellerton Ph: 702-384-0013
 University Medical Center of Southern Nevada
 John Allan Ellerton Ph: 702-384-0013
New Hampshire
  Concord
 New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care
 Frederick M. Briccetti Ph: 800-339-6484
  Hooksett
 New Hampshire Oncology - Hematology, PA - Hooksett
 Frederick M. Briccetti Ph: 800-339-6484
  Laconia
 Lakes Region General Hospital
 Frederick M. Briccetti Ph: 800-339-6484
  Londonderry
 Dana-Farber Cancer Institute at Londonderry
 Beverly Moy Ph: 877-726-5130
New Jersey
  Camden
 Cancer Institute of New Jersey at Cooper University Hospital - Camden
 Stephen Scott Grubbs Ph: 302-733-6227
North Carolina
  Burlington
 Alamance Cancer Center at Alamance Regional Medical Center
 Timothy J Finnegan Ph: 336-538-7725
  Charlotte
 Presbyterian Cancer Center at Presbyterian Hospital
 Justin P Favaro Ph: 704-384-5369
  Goldsboro
 Wayne Memorial Hospital, Incorporated
 James N. Atkins Ph: 919-580-0000
  Kinston
 Kinston Medical Specialists
 Peter R. Watson Ph: 252-559-2200
North Dakota
  Fargo
 Roger Maris Cancer Center at MeritCare Hospital
 Preston D. Steen Ph: 701-234-6161
 Preston D. Steen Ph: 701-234-6161
 Sanford Clinic North-Fargo
 Preston D. Steen Ph: 701-234-6161
  Grand Forks
 Altru Cancer Center at Altru Hospital
 Grant R Seeger Ph: 701-780-6520
  Minot
 Trinity CancerCare Center
 Stephen N Makoni Ph: 800-862-0005
Ohio
  Cincinnati
 Bethesda North Hospital
 Ching Ho Ph: 513-862-2230
 Good Samaritan Hospital Cancer Treatment Center
 Ching Ho Ph: 513-862-2230
  Dayton
 CCOP - Dayton
 Howard M. Gross Ph: 765-983-3000
 David L. Rike Cancer Center at Miami Valley Hospital
 Howard M. Gross Ph: 765-983-3000
 Good Samaritan Hospital
 Howard M. Gross Ph: 765-983-3000
 Grandview Hospital
 Howard M. Gross Ph: 765-983-3000
  Findlay
 Blanchard Valley Regional Cancer Center
 Howard M. Gross Ph: 765-983-3000
  Franklin
 Atrium Medical Center
 Howard M. Gross Ph: 765-983-3000
  Greenville
 Wayne Hospital
 Howard M. Gross Ph: 765-983-3000
  Kettering
 Charles F. Kettering Memorial Hospital
 Howard M. Gross Ph: 765-983-3000
  Troy
 UVMC Cancer Care Center at Upper Valley Medical Center
 Howard M. Gross Ph: 765-983-3000
  Wright-Patterson Afb
 United States Air Force Medical Center - Wright-Patterson
 Brandon J Cutler Ph: 937-257-1398
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Wajeeha Razaq Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
  Tulsa
 Cancer Care Associates-Yale
 Wajeeha Razaq Ph: 405-271-4272
  Email: julie-traylor@ouhsc.edu
Pennsylvania
  Sayre
 Guthrie Cancer Center at Guthrie Clinic Sayre
 Cynthia A Lynch Ph: 800-836-0388
  Williamsport
 Susquehanna Cancer Center at Divine Providence Hospital
 Warren L Robinson Ph: 800-598-4282
South Dakota
  Aberdeen
 Conklin Regional Cancer Center
 Richard J. Conklin Ph: 605-622-5613
  Sioux Falls
 Sanford Cancer Center at Sanford USD Medical Center
 Miroslaw A Mazurczak Ph: 605-328-1367
 Miroslaw A Mazurczak Ph: 605-328-1367
Tennessee
  Bristol
 Blue Ridge Medical Specialists, PC
 Asheesh Shipstone Ph: 423-578-8538
  Kingsport
 Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
 Asheesh Shipstone Ph: 423-578-8538
 Kingsport Hematology-Oncology Associates
 Asheesh Shipstone Ph: 423-578-8538
Texas
  Laredo
 Doctor's Hospital of Laredo
 Gary W. Unzeitig
  Email: calgbco@calgb.org
Virginia
  Fairfax
 Medical Oncology and Hematology Associates of North Virginia - Fairfax
 Mary J Wilkinson Ph: 703-720-5210ext1044
  Martinsville
 Ravenel Oncology Center at Memorial Hospital of Martinsville and Henry County
 Sreedhar Katragadda Ph: 276-666-7827
  Norton
 Southwest Virginia Regional Cancer Center at Wellmonth Health
 Asheesh Shipstone Ph: 423-578-8538
Wisconsin
  Eau Claire
 Marshfield Clinic Cancer Care at Regional Cancer Center
 Rezwan Islam Ph: 715-393-1400
  Green Bay
 Green Bay Oncology, Limited at St. Mary's Hospital
 Anthony J. Jaslowski Ph: 800-432-6049
 Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
 Anthony J. Jaslowski Ph: 800-432-6049
 St. Mary's Hospital Medical Center - Green Bay
 Anthony J. Jaslowski Ph: 800-432-6049
 Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center
 Dhimant R. Patel Ph: 800-252-2990
  La Crosse
 Franciscan Skemp Healthcare - La Crosse Campus
 Paula Gill Ph: 608-392-9462
 Gundersen Lutheran Center for Cancer and Blood
 Michael O Ojelabi Ph: 608-775-2385
  Email: cancerctr@gundluth.org
  Madison
 Dean Hematology & Oncology Clinic
 Amit Sanyal Ph: 608-410-2700
  Manitowoc
 Holy Family Memorial Medical Center Cancer Care Center
 Anthony J. Jaslowski Ph: 800-432-6049
  Marinette
 Bay Area Cancer Care Center at Bay Area Medical Center
 Anthony J. Jaslowski Ph: 800-432-6049
 Vince Lombardi Cancer Clinic - Marinette
 Dhimant R. Patel Ph: 800-252-2990
  Marshfield
 Marshfield Clinic - Marshfield Center
 Rezwan Islam Ph: 715-393-1400
  Minocqua
 Marshfield Clinic - Lakeland Center
 Rezwan Islam Ph: 715-393-1400
  Oconto Falls
 Green Bay Oncology, Limited - Oconto Falls
 Anthony J. Jaslowski Ph: 800-432-6049
  Oshkosh
 Vince Lombardi Cancer Clinic - Oshkosh
 Dhimant R. Patel Ph: 800-252-2990
  Rhinelander
 Ministry Medical Group at Saint Mary's Hospital
 Rezwan Islam Ph: 715-393-1400
  Rice Lake
 Marshfield Clinic - Indianhead Center
 Rezwan Islam Ph: 715-393-1400
  Sheboygan
 Saint Nicholas Hospital
 Anthony J. Jaslowski Ph: 800-432-6049
 Vince Lombardi Cancer Clinic - Sheboygan
 Dhimant R. Patel Ph: 800-252-2990
  Stevens Point
 Marshfield Clinic at Saint Michael's Hospital
 Rezwan Islam Ph: 715-393-1400
  Sturgeon Bay
 Green Bay Oncology, Limited - Sturgeon Bay
 Anthony J. Jaslowski Ph: 800-432-6049
  Summit
 Aurora Medical Center
 Dhimant R. Patel Ph: 800-252-2990
  Two Rivers
 Vince Lombardi Cancer Clinic - Two Rivers
 Dhimant R. Patel Ph: 800-252-2990
  Wausau
 Marshfield Clinic - Wausau Center
 Rezwan Islam Ph: 715-393-1400
  Wauwatosa
 Oncology Alliance, SC - Milwaukee - West
 Rubina Qamar Ph: 888-709-2080
  Weston
 Marshfield Clinic - Weston Center
 Rezwan Islam Ph: 715-393-1400
  Wisconsin Rapids
 Marshfield Clinic - Wisconsin Rapids Center
 Rezwan Islam Ph: 715-393-1400
Wyoming
  Casper
 Rocky Mountain Oncology
 Benjamin Thomas Marchello Ph: 800-648-6274
  Sheridan
 Welch Cancer Center at Sheridan Memorial Hospital
 Benjamin Thomas Marchello Ph: 800-648-6274

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01573442
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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