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



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer, Hot Flash, Orthopedic, Psychiatric
Therapuetic Areas:Oncology, Psychiatry / Psychology, Orthopedics / Podiatry, Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/17/2018
Start Date:August 2013

Use our guide to learn which trials are right for you!

Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias

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.

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.

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
We found this trial at
529
sites
La Crosse, Wisconsin 54601
Principal Investigator: Paula Gill
Phone: 855-776-0015
?
mi
from
La Crosse, WI
Click here to add this to my saved trials
Bremerton, Washington 98310
Principal Investigator: Mehmet S. Copur
Phone: 501-622-2100
?
mi
from
Bremerton, WA
Click here to add this to my saved trials
701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Principal Investigator: Peter R. Watson
Phone: 252-559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
?
mi
from
Kinston, NC
Click here to add this to my saved trials
1800 West Charleston Boulevard
Las Vegas, Nevada 89102
(702) 383-2000
Principal Investigator: John A. Ellerton
Phone: 805-474-9143
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Armando E. Giuliano
Phone: 310-423-8965
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
777 Hemlock Street
Macon, Georgia 31201
(478) 633-1000
Principal Investigator: Frederick M. Schnell
Phone: 478-633-1226
Medical Center of Central Georgia Navicent Health is a designated Level I Trauma Center and...
?
mi
from
Macon, GA
Click here to add this to my saved trials
4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
?
mi
from
Portland, OR
Click here to add this to my saved trials
Seattle, Washington 98104
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Aberdeen, South Dakota 57401
?
mi
from
Aberdeen, SD
Click here to add this to my saved trials
Aberdeen, Washington 98520
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
?
mi
from
Aberdeen, WA
Click here to add this to my saved trials
818 Riverside Ave.
Adrian, Michigan 49221
(517) 265-0900
Bixby Medical Center ProMedica's Mission is to improve your health and well-being. Which is why,...
?
mi
from
Adrian, MI
Click here to add this to my saved trials
Adrian, Michigan 49221
?
mi
from
Adrian, MI
Click here to add this to my saved trials
1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
Principal Investigator: Esther H. Rehmus
Phone: 330-344-6348
Akron General Medical Center It
?
mi
from
Akron, OH
Click here to add this to my saved trials
1111 Duff Ave
Ames, Iowa 50010
(866) 972-5477
Phone: 515-956-2759
McFarland Clinic PC-William R Bliss Cancer Center The William R. Bliss Cancer Center at Mary...
?
mi
from
Ames, IA
Click here to add this to my saved trials
Ames, Iowa 50010
Phone: 515-956-2759
?
mi
from
Ames, IA
Click here to add this to my saved trials
Anaconda, Montana 59711
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
?
mi
from
Anaconda, MT
Click here to add this to my saved trials
Anacortes, Washington 98221
Principal Investigator: Keith S. Lanier
Phone: 503-215-2614
?
mi
from
Anacortes, WA
Click here to add this to my saved trials
Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Anchorage, Alaska 99508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Anchorage, Alaska 99504
Principal Investigator: Keith S. Lanier
Phone: 503-215-2614
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Anchorage, Alaska 98508
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
?
mi
from
Anchorage, AK
Click here to add this to my saved trials
Appleton, Wisconsin 54911
Principal Investigator: Matthias Weiss
Phone: 920-380-1500
?
mi
from
Appleton, WI
Click here to add this to my saved trials
Athens, Georgia 30607
Principal Investigator: Sharad A. Ghamande
Phone: 706-721-1663
?
mi
from
Athens, GA
Click here to add this to my saved trials
1000 Johnson Ferry Rd NE
Atlanta, Georgia 30342
(404) 851-8000
Principal Investigator: Colleen S. Austin
Phone: 404-303-3355
Northside Hospital Northside Hospital-Atlanta (in Sandy Springs) opened in 1970. The original facility had 250...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Auburn, California 95602
Principal Investigator: Edmund W. Tai
Phone: 415-209-2686
?
mi
from
Auburn, CA
Click here to add this to my saved trials
Auburn, California 95603
Principal Investigator: Edmund W. Tai
Phone: 415-209-2686
?
mi
from
Auburn, CA
Click here to add this to my saved trials
Augusta, Georgia 30912
Principal Investigator: Sharad A. Ghamande
Phone: 706-721-1663
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Aurora, Colorado 80012
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
?
mi
from
Aurora, CO
Click here to add this to my saved trials
1501 S Potomac St
Aurora, Colorado 80012
(303) 695-2600
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Medical Center of Aurora At The Medical Center of Aurora and Centennial Medical Plaza patients...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
2000 Ogden Ave
Aurora, Illinois 60504
(630) 978-6200
Principal Investigator: Kendrith M. Rowland
Phone: 630-978-6212
Rush - Copley Medical Center Rush-Copley is proud to be the leading provider of health...
?
mi
from
Aurora, IL
Click here to add this to my saved trials
Ballwin, Missouri 63011
Principal Investigator: Jay W. Carlson
Phone: 888-221-4849
?
mi
from
Ballwin, MO
Click here to add this to my saved trials
4305 New Shepherdsville Road
Bardstown, Kentucky 40004
Principal Investigator: Mehmet S. Copur
Phone: 501-622-2100
?
mi
from
Bardstown, KY
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Beech Grove, Indiana 46107
?
mi
from
Beech Grove, IN
Click here to add this to my saved trials
Bellingham, Washington 98225
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
?
mi
from
Bellingham, WA
Click here to add this to my saved trials
Belmont, North Carolina 28012
Principal Investigator: William J. Charles
Phone: 704-834-2932
?
mi
from
Belmont, NC
Click here to add this to my saved trials
1300 Anne Street NW
Bemidji, Minnesota 56601
(218) 751-5430
Principal Investigator: Preston D. Steen
Phone: 712-252-0088
Sanford Clinic North-Bemidgi Sanford Health is a voluntary, not-for-profit health care organization. Through its entities,...
?
mi
from
Bemidji, MN
Click here to add this to my saved trials
Bend, Oregon 97701
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
?
mi
from
Bend, OR
Click here to add this to my saved trials
Berkeley, California 94704
Principal Investigator: Edmund W. Tai
Phone: 415-209-2686
?
mi
from
Berkeley, CA
Click here to add this to my saved trials
Bettendorf, Iowa 52722
Principal Investigator: David M. Spector
Phone: 563-359-9876
?
mi
from
Bettendorf, IA
Click here to add this to my saved trials
?
mi
from
Bettendorf, IA
Click here to add this to my saved trials
Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
?
mi
from
Billings, MT
Click here to add this to my saved trials
1233 North 30th Street
Billings, Montana 59101
406-237-7000
Principal Investigator: Benjamin T. Marchello
Phone: 800-648-6274
Saint Vincent Healthcare The Sisters of Charity of Leavenworth, Kansas, founded St. Vincent Healthcare in...
?
mi
from
Billings, MT
Click here to add this to my saved trials
Billings, Montana 59102
?
mi
from
Billings, MT
Click here to add this to my saved trials
Billings, Montana 59101
Principal Investigator: Benjamin T. Marchello
Phone: 800-648-6274
?
mi
from
Billings, MT
Click here to add this to my saved trials
300 N. Seventh St.
Bismarck, North Dakota 58501
(701) 323-6000
Principal Investigator: Preston D. Steen
Phone: 712-252-0088
Sanford Bismarck Medical Center Whether your stay in our hospital is one day for same...
?
mi
from
Bismarck, ND
Click here to add this to my saved trials
1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
Principal Investigator: James L. Wade
Phone: 309-243-3605
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
?
mi
from
Bloomington, IL
Click here to add this to my saved trials
Bloomington, Illinois 61701
Principal Investigator: James L. Wade
Phone: 217-876-4740
?
mi
from
Bloomington, IL
Click here to add this to my saved trials
100 E Idaho St
Boise, Idaho 83712
(208) 381-2711
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
Saint Luke's Mountain States Tumor Institute For more than 100 years, St. Luke
?
mi
from
Boise, ID
Click here to add this to my saved trials
Bolivar, Missouri 65613
?
mi
from
Bolivar, MO
Click here to add this to my saved trials
Bonne Terre, Missouri 63628
Principal Investigator: James L. Wade
Phone: 309-243-3605
?
mi
from
Bonne Terre, MO
Click here to add this to my saved trials
Boone, Iowa 50036
Phone: 515-956-2759
?
mi
from
Boone, IA
Click here to add this to my saved trials
55 Fruit St
Boston, Massachusetts 02114
(617) 724-4000
Massachusetts General Hospital Cancer Center An integral part of one of the world
?
mi
from
Boston, MA
Click here to add this to my saved trials
1100 Balsam Ave
Boulder, Colorado 80304
(303) 440-2273
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
Boulder Community Hospital Founded in 1922 as a community-owned and operated not-for-profit hospital, Boulder Community...
?
mi
from
Boulder, CO
Click here to add this to my saved trials
Boulder, Colorado 80303
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
?
mi
from
Boulder, CO
Click here to add this to my saved trials
960 W Wooster St
Bowling Green, Ohio 43402
419-353-5419
Toledo Clinic Cancer Centers-Bowling Green Our doctors evaluate and make recommendations regarding cancer treatment for...
?
mi
from
Bowling Green, OH
Click here to add this to my saved trials
915 Highland Blvd
Bozeman, Montana 59715
(406) 414-5000
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Bozeman Deaconess Hospital Bozeman Deaconess Hospital is a Joint Commission certified, licensed Level III trauma...
?
mi
from
Bozeman, MT
Click here to add this to my saved trials
Bremerton, Washington 98310
Principal Investigator: Mehmet S. Copur
Phone: 501-622-2100
?
mi
from
Bremerton, WA
Click here to add this to my saved trials
Bristol, Tennessee 37620
Principal Investigator: Asheesh Shipstone
Phone: 423-224-5593
?
mi
from
Bristol, TN
Click here to add this to my saved trials
?
mi
from
Bristol, TN
Click here to add this to my saved trials
Bryan, Texas 77802
Principal Investigator: Mehmet S. Copur
Phone: 501-622-2100
?
mi
from
Bryan, TX
Click here to add this to my saved trials
Burbank, California
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
?
mi
from
Burbank, CA
Click here to add this to my saved trials
Burien, Washington 98166
Principal Investigator: Mehmet S. Copur
Phone: 501-622-2100
?
mi
from
Burien, WA
Click here to add this to my saved trials
1501 Trousdale Drive
Burlingame, California 94010
Principal Investigator: Edmund W. Tai
Phone: 415-209-2686
?
mi
from
Burlingame, CA
Click here to add this to my saved trials
Burlington, North Carolina 27216
?
mi
from
Burlington, NC
Click here to add this to my saved trials
Burlington, Wisconsin 53105
Principal Investigator: Rubina Qamar
Phone: 414-649-5717
?
mi
from
Burlington, WI
Click here to add this to my saved trials
400 South Clark Street
Butte, Montana 59701
406-723-2500
Phone: 406-237-5460
Saint James Community Hospital and Cancer Treatment Center St. James Healthcare has played an important...
?
mi
from
Butte, MT
Click here to add this to my saved trials
?
mi
from
Camden, NJ
Click here to add this to my saved trials
Cameron Park, California 95682
Principal Investigator: Edmund W. Tai
Phone: 415-209-2686
?
mi
from
Cameron Park, CA
Click here to add this to my saved trials
210 W Walnut St
Canton, Illinois 61520
309-647-5240
Principal Investigator: James L. Wade
Phone: 309-243-3605
Illinois CancerCare - Canton Illinois CancerCare is one of the largest private oncology and hematology...
?
mi
from
Canton, IL
Click here to add this to my saved trials
211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
Principal Investigator: James L. Wade
Phone: 309-243-3605
Saint Francis Medical Center Saint Francis Medical Center is a 282-bed facility serving more than...
?
mi
from
Cape Girardeau, MO
Click here to add this to my saved trials
789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
(573) 519-4725
Principal Investigator: James L. Wade
Phone: 309-243-3605
Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
?
mi
from
Cape Girardeau, MO
Click here to add this to my saved trials
Carbondale, Illinois 62902
Principal Investigator: James L. Wade
Phone: 309-243-3605
?
mi
from
Carbondale, IL
Click here to add this to my saved trials
Carterville, Illinois 62918
Principal Investigator: James L. Wade
Phone: 309-243-3605
?
mi
from
Carterville, IL
Click here to add this to my saved trials
160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
Principal Investigator: James L. Wade
Phone: 309-243-3605
Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
?
mi
from
Carthage, IL
Click here to add this to my saved trials
6501 E 2nd St
Casper, Wyoming 82609
(307) 235-5433
Rocky Mountain Oncology Rocky Mountain Oncology Center is a spacious, comfortable, state-of-the-art 19,000 square foot...
?
mi
from
Casper, WY
Click here to add this to my saved trials
Castro Valley, California 94546
Principal Investigator: Edmund W. Tai
Phone: 415-209-2686
?
mi
from
Castro Valley, CA
Click here to add this to my saved trials
Cedar Rapids, Iowa 52403
Principal Investigator: Deborah W. Wilbur
Phone: 319-365-4673
?
mi
from
Cedar Rapids, IA
Click here to add this to my saved trials
Cedar Rapids, Iowa 52403
Principal Investigator: Deborah W. Wilbur
Phone: 319-365-4673
?
mi
from
Cedar Rapids, IA
Click here to add this to my saved trials
Centerville, Ohio 45459
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
?
mi
from
Centerville, OH
Click here to add this to my saved trials
Centerville, Ohio 45459
Principal Investigator: Howard M. Gross
Phone: 937-775-1350
?
mi
from
Centerville, OH
Click here to add this to my saved trials
Centralia, Illinois 62801
Principal Investigator: James L. Wade
Phone: 309-243-3605
?
mi
from
Centralia, IL
Click here to add this to my saved trials
Centralia, Washington 98531
Principal Investigator: Alison K. Conlin
Phone: 907-212-6871
?
mi
from
Centralia, WA
Click here to add this to my saved trials
505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
Principal Investigator: Shaker R. Dakhil
Phone: 316-268-5374
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
?
mi
from
Chanute, KS
Click here to add this to my saved trials
Charleston, South Carolina 29401
Principal Investigator: Steven A. Akman
Phone: 843-720-8386
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charleston, South Carolina 29403
Principal Investigator: Steven A. Akman
Phone: 843-720-8386
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charleston, South Carolina 29414
Phone: 843-577-2276
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charleston, South Carolina 29414
Principal Investigator: Steven A. Akman
Phone: 843-720-8386
?
mi
from
Charleston, SC
Click here to add this to my saved trials
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charleston, South Carolina 29406
Principal Investigator: Steven A. Akman
Phone: 843-720-8386
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28204
Principal Investigator: Nasfat Shehadeh
Phone: 704-384-5369
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
Phone: 704-342-1900
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
Phone: 704-342-1900
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28262
Phone: 704-342-1900
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chattanooga, Tennessee 37404
Principal Investigator: Mehmet S. Copur
Phone: 501-622-2100
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Cheyenne, Wyoming 82001
Principal Investigator: Keren Sturtz
Phone: 303-777-2663
?
mi
from
Cheyenne, WY
Click here to add this to my saved trials
Chicago, Illinois 60640
Principal Investigator: Stuart A. Krauss
Phone: 773-564-5032
?
mi
from
Chicago, IL
Click here to add this to my saved trials