Ensayos clínicos

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