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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01573442
First received: April 6, 2012
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Arthralgia
Breast Cancer
Hot Flashes
Musculoskeletal Complications
Sexual Dysfunction
Drug: therapeutic testosterone
Other: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • The intra-patient change in joint pain at 3 months from baseline as measured by the Brief Pain Inventory for aromatase-inhibitor arthralgias (BPI-AIA) [ Time Frame: Up to 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of transdermal testosterone assessed using Common Terminology Criteria for Adverse Events (CTCAE) 4.0 and additional questionnaires, including alopecia, acne, and hirsutism as reported by the patient [ Time Frame: Up to 6 months post treatment ] [ Designated as safety issue: Yes ]
  • The intra-patient change in joint pain and its interference of activity for each month from baseline as measured by BPI-AIA [ Time Frame: Up to 6 months post treatment ] [ Designated as safety issue: No ]
  • The change of hot flashes during the first two months from baseline as measured by hot flash diary [ Time Frame: Up to 2 months ] [ Designated as safety issue: No ]
  • The change of libido and menopause-specific quality of life from baseline as measured by MENQOL and POMS monthly [ Time Frame: Up to 6 months post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 224
Study Start Date: August 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients receive testosterone transdermally on day 1 and then at 3 months.
Drug: therapeutic testosterone
Given transdermally
Placebo Comparator: Arm II
Patients receive placebo transdermally on day 1 and then at 3 months.
Other: placebo
Given transdermally

Detailed Description:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT01573442

  Hide Study Locations
Locations
United States, California
Palo Alto Medical Foundation-Camino Division Recruiting
El Camino Real Mountain View, California, United States, 94040
Contact: Peter Yu, M.D.    (408) 730-2817      
Washington Hospital Recruiting
Fremont, California, United States, 94538
Contact: Vandana Sharma, M.D.    510-794-5320      
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Armando Giuliano, M.D.    310-423-9331      
Palo Alto Medical Foundation Recruiting
Palo Alto, California, United States, 94301
Contact: David S. Leibowitz    650-321-4121      
United States, Colorado
The Medical Center of Aurora Recruiting
Aurora, Colorado, United States, 80012
Contact: Keren Sturtz, M.D.    303-777-2663      
Boulder Community Hospital Recruiting
Boulder, Colorado, United States, 80301
Contact: Keren Sturtz, M.D.    303-777-2663      
Penrose-Saint Francis Healthcare Recruiting
Colorado Springs, Colorado, United States, 80907
Contact: Keren Sturtz, M.D.    303-777-2663      
Rose Medical Center Recruiting
Denver, Colorado, United States, 80220
Contact: Keren Sturtz, M.D.    303-777-2663      
Porter Adventist Hospital Recruiting
Denver, Colorado, United States, 80210
Contact: Keren Sturtz, M.D.    303-777-2663      
Presbyterian - Saint Lukes Medical Center - Health One Recruiting
Denver, Colorado, United States, 80218
Contact: Keren Sturtz, M.D.    303-777-2663      
Colorado Cancer Research Program CCOP Recruiting
Denver, Colorado, United States, 80222
Contact: Keren Sturtz, M.D.    303-777-2663      
Exempla Saint Joseph Hospital Recruiting
Denver, Colorado, United States, 80218
Contact: Keren Sturtz, M.D.    303-777-2663      
Swedish Medical Center Recruiting
Englewood, Colorado, United States, 80110
Contact: Keren Sturtz, M.D.    303-777-2663      
North Colorado Medical Center Recruiting
Greeley, Colorado, United States, 80631
Contact: Keren Sturtz, M.D.    303-777-2663      
Saint Anthony Hospital Recruiting
Lakewood, Colorado, United States, 80228
Contact: Keren Sturtz, M.D.    303-777-2663      
Littleton Adventist Hospital Recruiting
Littleton, Colorado, United States, 80122
Contact: Keren Sturtz, M.D.    303-777-2663      
Sky Ridge Medical Center Recruiting
Lone Tree, Colorado, United States, 80124
Contact: Keren Sturtz, M.D.    303-777-2663      
Longmont United Hospital Recruiting
Longmont, Colorado, United States, 80501
Contact: Keren Sturtz, M.D.    303-777-2663      
McKee Medical Center Recruiting
Loveland, Colorado, United States, 80539
Contact: Keren Sturtz, M.D.    303-777-2663      
Parker Adventist Hospital Recruiting
Parker, Colorado, United States, 80138
Contact: Keren Sturtz, M.D.    303-777-2663      
Saint Mary Corwin Medical Center Recruiting
Pueblo, Colorado, United States, 81004
Contact: Keren Sturtz, M.D.    303-777-2663      
Exempla Lutheran Medical Center Recruiting
Wheat Ridge, Colorado, United States, 80033
Contact: Karen Sturtz, M.D.    303-777-2663      
United States, Florida
Lakeland Regional Cancer Center at Lakeland Regional Medical Center Recruiting
Lakeland, Florida, United States, 33805
Contact: Madhavi L. Venigalla, MD    508-368-3168      
United States, Georgia
John B. Amos Community Cancer Center Recruiting
Columbus, Georgia, United States, 31902
Contact: Andrew Pippas, MD    706-320-8780      
United States, Illinois
Ingalls Memorial Hospital Recruiting
Harvey, Illinois, United States, 60426
Contact: Mark F. Kozloff    708-339-4800      
Porubcin, Michael (UIA Investigator) Recruiting
Moline, Illinois, United States, 61265
Contact: Costas L. Constantinou, MD    563-359-9876      
Spector, David MD (UIA Investigator) Recruiting
Moline, Illinois, United States, 61265
Contact: Costas Constantinou    563-359-9876      
Trinity Medical Center - East Recruiting
Moline, Illinois, United States, 61265
Contact: Costas L. Constantinou, MD    309-779-5092      
United States, Indiana
Franciscan St. Francis Health Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Howard Gross    937-775-1353      
Reid Hospital & Health Care Services, Incorporated Recruiting
Richmond, Indiana, United States, 47374
Contact: Howard M. Gross, MD    765-983-3000      
United States, Iowa
McFarland Clinic, P.C. Recruiting
Ames, Iowa, United States, 50010
Contact: Joseph J. Merchant, MD    515-239-4400      
McFarland Clinic Recruiting
Ames, Iowa, United States, 50010
Contact: Joseph Merchant, M.D.    515-956-2759      
Constantinou, Costas L MD (UIA Investigator) Recruiting
Bettendorf, Iowa, United States, 52722
Contact: Costas Constantinou, M.D.    563-359-9876      
Cedar Rapids Oncology Association Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Debra Wilbur    319-363-8303      
Mercy Hospital Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Deborah Wilbur    319-363-8303      
Principal Investigator: Deborah Wilbur         
Oncology Associates at Mercy Medical Center Recruiting
Cedar Rapids, Iowa, United States, 52403
Contact: Deborah Wilbur    319-363-8303      
United States, Kentucky
Saint Elizabeth Medical Center South Recruiting
Edgewood, Kentucky, United States, 41017
Contact: Joseph Guenther, M.D.    859-301-9186      
Saint Elizabeth Fort Thomas Recruiting
Fort Thomas, Kentucky, United States, 41075
Contact: Joseph Guenther, M.D.    859-301-9186      
United States, Louisiana
Ochsner Clinic Foundation-Baton Rouge Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: John Cole, M.D.    504-842-3261      
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: John Cole, M.D.    504-842-3261      
Ochsner Baptist Medical Center Recruiting
New Orleans, Louisiana, United States, 70115
Contact: John Cole, M.D.    504-842-3261      
United States, Maine
Central Maine Comprehensive Cancer Center at Central Maine Medical Center Recruiting
Lewiston, Maine, United States, 04240
Contact: Nicholette Erickson, MD    207-795-2440      
United States, Michigan
Bixby Medical Center Recruiting
Adrian, Michigan, United States, 49221
Contact: Rex Mowat    517-263-2507      
Toledo Clinic Cancer Centers - Adrian Recruiting
Adrian, Michigan, United States, 49221
Contact: Rex Mowat    517-263-2507      
Green Bay Oncology - Escanaba Recruiting
Escanaba, Michigan, United States, 49431
Contact: Anthony J. Jaslowski    610-402-2273      
Principal Investigator: Anthony J. Jaslowski         
Green Bay Oncology - Iron Mountain Recruiting
Iron Mountain, Michigan, United States, 49801
Contact: Anthony J. Jaslowski    610-402-2273      
Mercy Memorial Hospital - Monroe Recruiting
Monroe, Michigan, United States, 48162
Contact: Rex B. Mowat    734-240-8400      
Toledo Clinic Cancer Centers - Monroe Recruiting
Monroe, Michigan, United States, 48162
Contact: Rex Mowat    517-263-2507      
William Beaumont Hospital - Royal Oak Campus Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Michael J. Stender, MD    248-551-6911      
William Beaumont Hospital - Troy Recruiting
Troy, Michigan, United States, 48098
Contact: Michael Stender, M.D.    248-551-6911      
United States, Minnesota
Mayo Clinic Health Systems-Mankato Recruiting
Mankato, Minnesota, United States, 56002
Contact: Mohmmad Ranginwala    507-345-2929      
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Charles Loprinzi, M.D.    507-284-4849      
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Rebecca Aft, M.D.    314-747-0063      
United States, Montana
Frontier Cancer Center and Blood Institutes - Billings Recruiting
Billings, Montana, United States, 59102
Contact: Benjamin Marchello    610-402-2273      
Billings Clinic Recruiting
Billings, Montana, United States, 59107-7000
Contact: Benjamin T. Marchello    610-402-2273      
Montana Cancer Consortium CCOP Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello    610-402-2273      
Saint Vincent Healthcare Recruiting
Billings, Montana, United States, 59101
Contact: Benjamin T. Marchello    610-402-2273      
Bozeman Deaconess Hospital Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello, MD    406-585-5000      
Bozeman Deaconess Cancer Center Recruiting
Bozeman, Montana, United States, 59715
Contact: Benjamin T. Marchello, MD    406-238-6290      
Saint James Community Hospital and Cancer Treatment Center Recruiting
Butte, Montana, United States, 59701
Contact: Benjamin T. Marchello    610-402-2273      
Benefis Healthcare - Sletten Cancer Institute Recruiting
Great Falls, Montana, United States, 59405
Contact: Benjamin T. Marchello    610-402-2273      
Saint Peter's Community Hospital Recruiting
Helena, Montana, United States, 59601
Contact: Benjamin T. Marchello    610-402-2273      
Kalispell Medical Oncology at KRMC Recruiting
Kalispell, Montana, United States, 59901
Contact: Benjamin T. Marchello, MD    406-238-6290      
Montana Cancer Specialists Recruiting
Missoula, Montana, United States, 59802
Contact: Benjamin T. Marchello    610-402-2273      
Saint Patrick Hospital - Community Hospital Recruiting
Missoula, Montana, United States, 59802
Contact: Benjamin T. Marchello    610-402-2273      
United States, Nevada
Nevada Cancer Research Foundation CCOP Recruiting
Las Vegas, Nevada, United States, 89106
Contact: John Ellerton    702-383-7336      
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: John Ellerton    702-383-7336      
United States, New Hampshire
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer Care Recruiting
Concord, New Hampshire, United States, 03301
Contact: Frederick M. Briccetti, MD    603-224-2556      
New Hampshire Oncology - Hematology, PA - Hooksett Recruiting
Hooksett, New Hampshire, United States, 03106
Contact: Frederick M. Briccetti, MD    603-224-2556      
LRGHealthcare-Lakes Region General Hospital Recruiting
Laconia, New Hampshire, United States, 03246
Contact: Frederick Briccetti, M.D.    603-552-9170      
United States, New Jersey
Englewood Hospital and Medical Center Recruiting
Englewood, New Jersey, United States, 07631
Contact: Jill Morrison, M.D.    201-568-5250      
United States, New York
Glens Falls Hospital Recruiting
Glen Falls, New York, United States, 12801
Contact: Eric Pillemer, M.D.    518-926-6620      
United States, North Carolina
Alamance Cancer Center at Alamance Regional Medical Center Recruiting
Burlington, North Carolina, United States, 27216
Contact: Timothy J. Finnegan    336-538-7725      
Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Justin Favaro, M.D.    704-342-1900      
Wayne Memorial Hospital, Incorporated Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James N. Atkins, MD    919-580-0000      
Wayne Memorial Hospital Recruiting
Goldsboro, North Carolina, United States, 27534
Contact: James Atkins, M.D.    919-580-0000      
Kinston Medical Specialists Recruiting
Kinston, North Carolina, United States, 28501
Contact: Peter R. Watson, MD    252-559-2200 ext 201      
United States, North Dakota
Altru Cancer Center at Altru Hospital Recruiting
Grand Forks, North Dakota, United States, 58201
Contact: Clinical Trails Office - Altru Cancer Center at Altru Hospital    701-780-6520      
Trinity CancerCare Center Recruiting
Minot, North Dakota, United States, 58701
Contact: Stephen N.C. Makoni    701-857-3535      
United States, Ohio
Toledo Clinic Cancer Centers - Bowling Green Recruiting
Bowling Green, Ohio, United States, 43402
Contact: Rex Mowat    517-263-2507      
Good Samaritan Hospital - Cincinnati Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Ching Ho, M.D.    513-891-1200      
Bethesda North Hospital Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Ching Ho    513-745-1111      
Dayton CCOP Recruiting
Dayton, Ohio, United States, 45420
Contact: Howard M. Gross    610-402-2273      
Principal Investigator: Howard M. Gross         
Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
Contact: Howard Gross    937-775-1353      
Samaritan North Health Center Recruiting
Dayton, Ohio, United States, 45415
Contact: Howard M. Gross    610-402-2273      
Good Samaritan Hospital Recruiting
Dayton, Ohio, United States, 45406
Contact: Howard M. Gross, MD    937-832-1093      
Grandview Hospital Recruiting
Dayton, Ohio, United States, 45405
Contact: Howard Gross    937-775-1353      
Community Health Partners Regional Medical Center - Mercy Cancer Center Recruiting
Elyria, Ohio, United States, 44035
Contact: Rex Mowat    517-263-2507      
Hematology Oncology Center Incorporated Recruiting
Elyria, Ohio, United States, 44035
Contact: Rex Mowat, M.D.    517-263-2507      
Blanchard Valley Hospital Recruiting
Findlay, Ohio, United States, 45840
Contact: Howard Gross    937-775-1353      
Atrium Medical Center-Middletown Regional Hospital Recruiting
Franklin, Ohio, United States, 45005-1066
Contact: Howard M. Gross    610-402-2273      
Principal Investigator: Howard M. Gross         
Wayne Hospital Recruiting
Greenville, Ohio, United States, 45331
Contact: Howard M. Gross, MD    937-832-1093      
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45429
Contact: Howard Gross    937-775-1364      
Lima Memorial Hospital Recruiting
Lima, Ohio, United States, 45804
Contact: Rex B. Mowat    419-228-3335      
Toledo Radiation Oncology at Northwest Ohio Oncology Center Recruiting
Maumee, Ohio, United States, 43537
Contact: Rex Mowat    517-263-2507      
Toledo Clinic Cancers Centers - Maumee Recruiting
Maumee, Ohio, United States, 43537
Contact: Rex Mowat    517-263-2507      
Saint Charles Hospital Recruiting
Oregon, Ohio, United States, 43616
Contact: Rex Mowat    517-263-2507      
Toledo Clinic Cancer Centers - Oregon Recruiting
Oregon, Ohio, United States, 43616
Contact: Rex Mowat    517-263-2507      
Flower Hospital Recruiting
Sylvania, Ohio, United States, 43560
Contact: Rex Mowat, M.D.    517-263-2507      
The Toledo Hospital/Toledo Children's Hospital Recruiting
Toledo, Ohio, United States, 43606
Contact: Rex Mowat    517-263-2507      
Toledo Clinic Cancer Centers - Toledo Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex Mowat    517-263-2507      
University of Toledo Recruiting
Toledo, Ohio, United States, 43614
Contact: Rex Mowat    517-263-2507      
Toledo Community Hospital Oncology Program CCOP Recruiting
Toledo, Ohio, United States, 43617
Contact: Rex Mowat    517-263-2507      
Saint Vincent Mercy Medical Center Recruiting
Toledo, Ohio, United States, 43608
Contact: Rex Mowat    517-263-2507      
Mercy Cancer Center - Saint Anne Mercy Hospital Recruiting
Toledo, Ohio, United States, 43623
Contact: Rex Mowat    517-263-2507      
Upper Valley Medical Center Recruiting
Troy, Ohio, United States, 45373
Contact: Howard Gross    937-775-1364      
Fulton County Health Center Recruiting
Wauseon, Ohio, United States, 43567
Contact: Rex Mowat    517-263-2507      
Greene Memorial Hospital Recruiting
Xenia, Ohio, United States, 45385
Contact: Howard Gross    937-775-1353      
United States, Pennsylvania
Geisinger Cancer Institute at Geisinger Health Recruiting
Danville, Pennsylvania, United States, 17822-0001
Contact: Clinical Trials Office - Geisinger Cancer Institute    570-271-5251      
Susquehanna Cancer Center at Divine Providence Hospital Recruiting
Williamsport, Pennsylvania, United States, 17701
Contact: Warren L. Robinson, Jr.    570-326-8000      
United States, South Carolina
Cancer Centers of the Carolinas - Easley Recruiting
Easley, South Carolina, United States, 29640
Contact: Jeffrey Giguere, M.D.    864-241-6251      
Cancer Centers of The Carolinas Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jeffrey Giguere, M.D.    864-241-6251      
Cancer Centers of the Carolinas - Faris Road Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jeffrey K. Giguere, MD, FACP    864-987-7000      
Greenville Cancer Center of the Carolinas (CCOP) Recruiting
Greenville, South Carolina, United States, 29615
Contact: Jeffrey Giguere, M.D.    864-522-3065      
Greenville Memorial Hospital Recruiting
Greenville, South Carolina, United States, 29605
Contact: Debbi Nunn    864-522-3065      
Cancer Centers of the Carolinas - Grove Commons Recruiting
Greenville, South Carolina, United States, 29605
Contact: Jeffrey Giguere, M.D.    864-241-6251      
Cancer Centers of the Carolinas-Greer Medical Oncology Recruiting
Greer, South Carolina, United States, 29650
Contact: Jeffrey Giguere, M.D.    864-241-6251      
Cancer Centers of the Carolinas - Seneca Recruiting
Seneca, South Carolina, United States, 29672
Contact: Jeffrey K. Giguere, MD, FACP    864-987-7000      
Cancer Centers of the Carolinas - Spartanburg Recruiting
Spartanburg, South Carolina, United States, 29307
Contact: Jeffrey K. Giguere, MD, FACP    864-987-7000      
United States, Tennessee
Wellmont Medical Associates-Oncology and Hematology Recruiting
Bristol, Tennessee, United States, 37620
Contact: Asheesh Shipstone, M.D.    423-578-8538      
Wellmont Holston Valley Hospital and Medical Center Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Asheesh Shipstone    423-578-8538      
University of Tennessee - Knoxville Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Timothy Panella, M.D.    865-305-8780      
Nashville Breast Center Recruiting
Nashville, Tennessee, United States, 37203
Contact: Kevin T. Palka    615-284-8229      
Meharry Medical College Recruiting
Nashville, Tennessee, United States, 37208
Contact: Kevin Palka, M.D.    615-327-6277      
United States, Texas
Doctor's Hospital of Laredo Recruiting
Laredo, Texas, United States, 78045
Contact: Gary W. Unzeitig, MD    956-726-3691      
United States, Virginia
Medical Oncology and Hematology Associates of North Virginia - Fairfax Recruiting
Fairfax, Virginia, United States, 22031
Contact: Mary J. Wilkinson    703-207-0733      
Fredericksburg Oncology Inc. Recruiting
Fredericksburg, Virginia, United States, 22401
Contact: Rex Mowat    517-263-2507      
Principal Investigator: Rex Mowat         
Memorial Hospital Of Martinsville Recruiting
Martinsville, Virginia, United States, 24115
Contact: Sreedhar Katragadda, M.D.    276-666-7827      
Southwest VA Regional Cancer Center Recruiting
Norton, Virginia, United States, 24273
Contact: Asheesh Shipstone    423-578-8538      
United States, Wisconsin
Marshfield Clinic Cancer Center at Sacred Heart Recruiting
Eau Claire, Wisconsin, United States, 54701
Contact: Rezwan Islam, M.D.    715-393-1400      
Green Bay Oncology at Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301-3526
Contact: Anthony J. Jaslowski    610-402-2273      
Saint Vincent Hospital Recruiting
Green Bay, Wisconsin, United States, 54301
Contact: Anthony Jaslowski, M.D.    920-884-3135      
Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Anthony J. Jaslowski    610-402-2273      
Green Bay Oncology Limited at Saint Mary's Hospital Recruiting
Green Bay, Wisconsin, United States, 54303
Contact: Anthony J. Jaslowski    610-402-2273      
Gundersen Lutheran Health System/CCOP Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Michael Ojelabi, M.D.    608-782-7300      
Dean Hematology and Oncology Clinic Recruiting
Madison, Wisconsin, United States, 53717
Contact: Amit Sanyal, M.D.    608-410-2800      
Holy Family Memorial Hospital Recruiting
Manitowoc, Wisconsin, United States, 54221
Contact: Anthony J. Jaslowski    610-402-2273      
Bay Area Medical Center Recruiting
Marinette, Wisconsin, United States, 54143
Contact: Anthony J. Jaslowski    610-402-2273      
Principal Investigator: Anthony J. Jaslowski         
Marshfield Clinic Recruiting
Marshfield, Wisconsin, United States, 54449
Contact: Rezwan Islam, M.D.    715-393-1400      
Marshfield Clinic-Minocqua Center Recruiting
Minocqua, Wisconsin, United States, 54548
Contact: Rezwan Islam, M.D.    715-393-1400      
Green Bay Oncology - Oconto Falls Recruiting
Oconto Falls, Wisconsin, United States, 54154
Contact: Anthony J. Jaslowski    610-402-2273      
Marshfield Clinic at James Beck Cancer Center Recruiting
Rhinelander, Wisconsin, United States, 54501
Contact: Rezwan Islam, M.D.    715-393-1400      
Marshfield Clinic-Rice Lake Center Recruiting
Rice Lake, Wisconsin, United States, 54868
Contact: Rezwan Islam, M.D.    715-393-1400      
Saint Nicholas Hospital Recruiting
Sheboygan, Wisconsin, United States, 53081
Contact: Anthony Jaslowski, M.D.    920-884-3135      
Marshfield Clinic - Wisconsin Rapids Center Recruiting
South Wisconsin Rapids, Wisconsin, United States, 54494
Contact: Rezwan Islam, M.D.    (715) 393-1400      
Marshfield Clinic Cancer Care at Saint Michael's Hospital Recruiting
Stevens Point, Wisconsin, United States, 54481
Contact: Rezwan Islam, M.D.    715-393-1400      
Green Bay Oncology - Sturgeon Bay Recruiting
Sturgeon Bay, Wisconsin, United States, 54235
Contact: Anthony J. Jaslowski    610-402-2273      
Marshfield Clinic-Wausau Center Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Rezwan Islam, M.D.    715-393-1400      
Marshfield Clinic - Weston Center Recruiting
Weston, Wisconsin, United States, 54476
Contact: Rezwan Islam, M.D.    715-393-1400      
United States, Wyoming
Rocky Mountain Oncology Recruiting
Casper, Wyoming, United States, 82609
Contact: Benjamin T. Marchello, MD    406-238-6290      
Welch Cancer Center Recruiting
Sheridan, Wyoming, United States, 82801
Contact: Benjamin T. Marchello    610-402-2273      
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Principal Investigator: Charles L. Loprinzi, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01573442     History of Changes
Other Study ID Numbers: A221102, CDR0000730083, NCI-2012-00719, U10CA037447
Study First Received: April 6, 2012
Last Updated: August 29, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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:
Hot Flashes
Breast Neoplasms
Arthralgia
Signs and Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Pain
Aromatase Inhibitors
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on October 19, 2014