Phase 3
N=227
Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment
Arthralgia · Breast Cancer · Hot Flashes · Musculoskeletal Complications · Sexual Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT01573442 ↗Enrolled (actual)
227
Serious AEs
3.0%
Results posted
Jun 2019
Primary outcome: Primary: Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3 — -1.9; -2.0 score on a scale — p=0.4952
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- testosterone (Drug); placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Alliance for Clinical Trials in Oncology
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3 |
-1.9; -2.0 | 0.4952 |
| PRIMARY Improvement in BPI Average Pain From Baseline to Month 3 |
55; 45; 49; 59 | 0.2116 |
| PRIMARY Change in BPI Average Change From Baseline Pain Score to Month Six Average Pain Score |
-2.2; -1.9 | 0.6760 |
| PRIMARY Change in BPI Average Pain From Baseline to Month 1-6 |
-1.2; -1.7; -1.9; -1.9; -1.9; -2.0 | 0.029 sig |
| SECONDARY Number of Participants With Grade 3 Or Higher Adverse Events Considered At Least Possibly Related to Treatment |
4; 8; 1; 1 | — |
| SECONDARY Number of Patients Who Reported Alopecia Using CTCAE 4.0 |
0; 0 | — |
| SECONDARY Number of Patients Who Reported Acne Using CTCAE 4.0 |
0; 0 | — |
| SECONDARY Number of Patients Who Reported Hirsutism Using CTCAE 4.0 |
94; 87; 7; 10; 0; 3 | 0.139 |
| SECONDARY Change in Hot Flash Frequency From Baseline to Week 8 |
-10.9; -11.4 | 0.8761 |
| SECONDARY The Change of Libido From Baseline to Month 3 as Measured by the MENQOL |
-0.5; -1.3 | 0.0176 sig |
| SECONDARY The Change of Menopause Specific Quality of Life From Baseline to Month 3 as Measured by MENQOL "How Bothered Are You by Hot Flashes" |
-1.4; -1.4 | 0.7077 |
| SECONDARY Change in BPI Worst Pain From Baseline to Month 3 |
-2.5; -2.4 | 0.8748 |
| SECONDARY Change in BPI Least Pain From Baseline to Month 3 |
-1.0; -1.3 | 0.4335 |
| SECONDARY Change in BPI Pain Right Now From Baseline to Month 3 |
-1.6; -2.1 | 0.286 |
| SECONDARY Change in Average Joint Stiffness From Baseline to Month 3 as Measured by BPI Item #5 (Joint Stiffness) |
-2.0; -2.2 | 0.7694 |
| SECONDARY The Intrapatient Change in Activity Level (Interference of Activity) for Each Month From Baseline as Measured by Item#6 (Interference) of the BPI-AIA. |
-2.1; -2.1 | 0.9609 |
Summary
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.
Eligibility Criteria
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:
- Creatinine ≤1.5 x ULN
- Hemoglobin > 11 g/dL
- WBC > 3.0
- Platelet Count > 100,000
- SGOT (AST) ≤ 1.5 x ULN
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, 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
Data sourced from ClinicalTrials.gov (NCT01573442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.