NCT01573442|CompletedPhase 3ResultsDMC

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

Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias

Alliance for Clinical Trials in Oncology ClinicalTrials.gov

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5 other identifiers

A221102CDR0000730083NCI-2012-00719U10CA037447UG1CA189823

Study Type

interventional

Target

227

Locations

2 countries

Sites

529

Timeline

RegisteredApr 2012

StartedSep 2013

CompletionSep 2019

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

227

participants targeted

Target at P25-P50 for phase_3

Timeline

Completed

Started Sep 2013

Longer than P75 for phase_3

Geographic Reach

2 countries

529 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6 years study duration

First Submitted

Initial submission to the registry

April 6, 2012

Completed

3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2012

Completed

1.4 years until next milestone

Study Start

First participant enrolled

September 10, 2013

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed

1.3 years until next milestone

Results Posted

Study results publicly available

June 5, 2019

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed

Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

4.5 years

First QC Date

April 6, 2012

Results QC Date

April 24, 2019

Last Update Submit

January 14, 2025

Conditions

Arthralgia Breast Cancer Hot Flashes Musculoskeletal Complications Sexual Dysfunction

Keywords

hot flashesmusculoskeletal complicationssexual dysfunctionestrogen receptor-positive breast cancerprogesterone receptor-positive breast cancerarthralgiastage IA breast cancerstage IB breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Outcome Measures

Primary Outcomes (4)

Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3
The average change in Brief Pain Inventory (BPI) Average Pain scores between baseline and month 3 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
From baseline to 3 months
Improvement in BPI Average Pain From Baseline to Month 3
"2. Was there an improvement in BPI Average Pain from baseline to month 3?"
Up to 3 months
Change in BPI Average Change From Baseline Pain Score to Month Six Average Pain Score
Change in BPI Average Change from Baseline Pain Score to Month Six Average Pain Score. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Baseline and 6 months
Change in BPI Average Pain From Baseline to Month 1-6
Change in BPI Average Pain from baseline to month 1-6. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.
Baseline and months 1-6

Secondary Outcomes (12)

Number of Participants With Grade 3 Or Higher Adverse Events Considered At Least Possibly Related to Treatment
Up to 6 months
Number of Patients Who Reported Alopecia Using CTCAE 4.0
Up to 6 months
Number of Patients Who Reported Acne Using CTCAE 4.0
Up to 6 months
Number of Patients Who Reported Hirsutism Using CTCAE 4.0
Up to 6 months
Change in Hot Flash Frequency From Baseline to Week 8
baseline and week 8
+7 more secondary outcomes

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive testosterone (0.264mL) topical application daily for six months.

Drug: testosterone

Arm II

PLACEBO COMPARATOR

Patients receive placebo (0.264mL) topical application daily for six months.

Other: placebo

Interventions

testosteroneDRUG

10.4 mg

Arm I

placeboOTHER

Arm II

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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
+3 more criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Alliance for Clinical Trials in Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (529)

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC