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

Completed · Phase 3 · Has a placebo group

Conditions studied: Arthralgia, Breast Cancer, Hot Flashes, Musculoskeletal Complications, Sexual Dysfunction

In brief

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.

Key facts

Study ID

NCT01573442

Run by

Alliance for Clinical Trials in Oncology

People needed

227

Starts

2013-09-10

Expected to finish

2019-09-01

Last updated by the study team

2025-01-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Creatinine ≤1.5 x ULN
• Hemoglobin > 11 g/dL
• WBC > 3.0
• Platelet Count > 100,000
• SGOT (AST) ≤ 1.5 x ULN

You may not qualify if…

• 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, as it is structurally similar to an androgen
• Concurrent radiation therapy or chemotherapy
• Current or planned use of cyclosporine, anticoagulants, oxphenbutazone, insulin, oral or injectable vitamin D doses over 4,000IU/day, or tamoxifen

Where it is running

• Anchorage Radiation Therapy Center — Anchorage, Alaska, United States
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States
• Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States
• Alaska Women's Cancer Care — Anchorage, Alaska, United States
• Anchorage Oncology Centre — Anchorage, Alaska, United States
• Katmai Oncology Group — Anchorage, Alaska, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• CHI Saint Vincent Cancer Center Hot Springs — Hot Springs, Arkansas, United States
• Sutter Auburn Faith Hospital — Auburn, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• Mills-Peninsula Medical Center — Burlingame, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• Sutter Davis Hospital — Davis, California, United States
• Epic Care-Dublin — Dublin, California, United States
• Bay Area Breast Surgeons Inc — Emeryville, California, United States
• Epic Care Partners in Cancer Care — Emeryville, California, United States
• Palo Alto Medical Foundation-Fremont — Fremont, California, United States
• Washington Hospital — Fremont, California, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• Contra Costa Regional Medical Center — Martinez, California, United States
• Memorial Medical Center — Modesto, California, United States
• Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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