Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias
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:
Age ≥ 18 years
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
Body Mass Index (BMI) between 18 and 35 kg/m^2
Women who have undergone a total mastectomy or breast conserving surgery for primary breast cancer +/-chemo, +/-radiotherapy.
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
Women who are postmenopausal by surgery, radiotherapy or presence of natural amenorrhea ≥ 12 months
≥ 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
Ability to complete questionnaire(s) by themselves or with assistance
ECOG Performance Status (PS) 0, 1 or 2
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
Laboratory values prior to registration as defined in the protocol:
Exclusion Criteria:
Burbank, California 91505, United States
Cameron Park, California 95682, United States
Roseville, California 95661, United States
Vacaville, California 95687, United States
Englewood, Colorado 80113, United States
Pekin, Illinois 61554, United States
Jefferson City, Missouri 65109, United States
Las Vegas, Nevada 89109, United States
Las Vegas, Nevada 89113, United States
Las Vegas, Nevada 89149, United States
Huntersville, North Carolina 28078, United States
Mooresville, North Carolina 28117, United States
Charleston, South Carolina 29414, United States
Spartanburg, South Carolina 29307, United States
Johnson City, Tennessee 37604, United States
Kingsport, Tennessee 37660, United States
Sturgeon Bay, Wisconsin 54235-1495, United States
Summit, Wisconsin 53066, United States