|Phase III||Biomarker/Laboratory analysis, Supportive care, Treatment||Approved-not yet active||18 and over||NCI, Other||CDR0000730083|
CALGB-A221102, NCCTG-N10C7, A221102, NCT01573442
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
- To determine whether testosterone will reduce aromatase inhibitor (AI)-induced arthralgia and associated joint symptoms.
- To explore whether testosterone will have an acceptable safety and tolerability profile, with particular reference to androgenic adverse events including acne, hirsutism, and alopecia.
- To explore whether testosterone will reduce AI-induced arthralgias and associated joint symptoms and their interference with activity. (Ancillary)
- To explore whether testosterone will reduce the incidence of hot flashes. (Ancillary)
- To explore whether testosterone will modify libido or change quality of life. (Ancillary)
- 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. (Ancillary)
OUTLINE: This is a multicenter study. Patients are stratified according to baseline pain score (5-6 vs 7-10) and age in years (< 50 vs 50-60 vs > 60). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive testosterone transdermally on day 1 and then at 3 months.
- Arm II: Patients receive placebo transdermally on day 1 and then at 3 months. Blood samples are collected at baseline and during treatment for correlative studies.
Patients complete the Hot Flash Diary daily for 2 months and the Profile of Mood States (POMS), the Hot Flash Related Daily Interference Scale (HFRDIS), the Modified Brief Pain Inventory, and the Menopause Specific Quality of Life Questionnaire (MENQOL) at baseline, after completion of treatment, and at 6 months.
After completion of study treatment, patients are followed up for 6 months.
- 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)
- 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
- No medical situations that would alter the laboratory values since they were done
- 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
- Patients may, or may not, be taking non-opiod analgesics
- 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, or tamoxifen
Trial Lead Organizations/Sponsors
Cancer and Leukemia Group BNational Cancer Institute
|Charles L. Loprinzi||Principal Investigator|
|Cancer and Leukemia Group B|
|Charles L. Loprinzi||Ph: 507-284-4565|
|La Grange Memorial Hospital|
|James E. Hannigan||Ph: 800-323-8622|
|St. Francis Hospital and Health Centers - Beech Grove Campus|
|Howard M. Gross||Ph: 765-983-3000|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01573442
Information obtained from ClinicalTrials.gov on April 04, 2013
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