Testosterone in Treating Postmenopausal Patients with Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment
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.
Inclusion Criteria
- Receiving anastrozole (1 mg) or letrozole (2.5 mg) orally once a day, for >= 21 days prior to registration and plan to continue 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 +/- chemotherapy, +/- radiotherapy
- Must have BOTH estrogen receptor (ER) and progesterone receptor (PR)-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 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 * Note: Patients may, or may not, be taking non-opioid analgesics
- Ability to complete questionnaire(s) by themselves or with assistance
- Eastern Cooperative Oncology Group (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
- Creatinine =< 1.5 x upper limit of normal (ULN) (=< 365 days prior to registration, without medical situations that should change these parameters since they were done)
- Hemoglobin > 11 g/dL (=< 365 days prior to registration, without medical situations that should change these parameters since they were done)
- White blood cell (WBC) > 3.0 (=< 365 days prior to registration, without medical situations that should change these parameters since they were done)
- Platelet count > 100,000 (=< 365 days prior to registration, without medical situations that should change these parameters since they were done)
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) =< 1.5 x ULN (=< 365 days prior to registration, without medical situations that should change these parameters since they were done)
Exclusion Criteria
- Presence of residual or recurrent cancer (locally or metastatic)
- Diabetes mellitus or glucose intolerance, defined as a fasting glucose > 125 mg/dL
- History of coronary artery disease (angina or myocardial infarction)
- Patients on hormone-replacement therapy (HRT) =< 4 weeks prior to registration; this includes the use of vaginal estrogen therapy
- Known hypersensitivity to any component of testosterone
- 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
- Receiving any other investigational agent
- History of a deep venous thrombosis or a thromboembolism
- Concurrent use of the aromatase inhibitor exemestane
- Concurrent radiation therapy or chemotherapy
- Current or planned use of cyclosporine, anticoagulants, insulin, oral or injectable vitamin D doses over 4,000 IU/day, or tamoxifen
Additional locations may be listed on ClinicalTrials.gov for NCT01573442.
Locations matching your search criteria
United States
Colorado
Denver
Kansas
Wichita
Maryland
Rockville
Montana
Billings
Nevada
Las Vegas
Wisconsin
Green Bay
PRIMARY OBJECTIVES
I. To determine whether testosterone will reduce aromatase inhibitor (AI)-induced arthralgia and associated joint symptoms.
SECONDARY OBJECTIVES:
I. To explore whether testosterone will have an acceptable safety and tolerability profile, with particular reference to androgenic adverse events including acne, hirsutism, and alopecia.
ANCILLARY OBJECTIVES:
I. To explore whether testosterone will reduce AI-induced arthralgias and associated joint symptoms and their interference with activity.
II. To explore whether testosterone will reduce the incidence of hot flashes.
III. To explore whether testosterone will modify libido or change quality of life.
IV. To explore whether identified single nucleotide polymorphisms (SNPs), that were associated with more AI-associated arthralgias in a previous prospective trial, are more commonly seen in the patients entered into the present clinical trial, than are observed in the normal population.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive testosterone via subcutaneous (SC) implant on day 1 and then at 3 months or testosterone gel topically once daily (QD) for 6 months.
Arm II: Patients receive placebo via SC implant on day 1 and then at 3 months or topically QD for 6 months.
After completion of study treatment, patients are followed up at 3 and 6 months and monthly thereafter.
Trial PhasePhase III
Trial Typesupportive care
Lead OrganizationAlliance for Clinical Trials in Oncology
Principal InvestigatorCharles Lawrence Loprinzi
- Primary IDA221102
- Secondary IDsNCI-2012-00719, CDR0000730083
- ClinicalTrials.gov IDNCT01573442