Add-on Study for Protocol G200802 (NCT02463032): Effect of GTx-024 on Maximal Neuromuscular Function and Lean Body Mass

Study Overview
=================
Brief Summary
-----------------
This is a multiple site, proof of concept feasibility study to describe the effect of GTx-024 9 or 18 mg on physical function in female subjects, from protocol G200802, with ER+/AR+ breast cancer.

Official Title
-----------------
Add-on Study for Protocol G200802 (NCT02463032): Effect of GTx-024 on Maximal Neuromuscular Function and Lean Body Mass

Conditions
-----------------
ER+ and AR+ Breast Cancer

Intervention / Treatment
-----------------
* Drug: GTx-024 9 or 18 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In screening for, and ultimately randomized into, protocol G200802 Give voluntary, written and signed, informed consent for this add-on study Age 18 to 70 years old Physically capable of mounting and riding a stationary bicycle Subject agrees to not significantly alter physical activity or current physical training during the study period Exclusion Criteria: Subject has a concomitant medical condition that precludes adequate study treatment compliance or assessment, or increases subject risk, in the opinion of the Investigator Subjects unwilling to or unable to comply with the protocol Any other condition which per investigators' judgement may increase subject risk

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GTx-024 9 or 18 mg<br>Patients enrolled in G200802 receiving GTx-024 9 or 18 mg | Drug: GTx-024 9 or 18 mg<br>* Patients enrolled in G200802 receiving GTx-024 9 or 18 mg<br>* Other names: Enobosarm;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Power Production | Describe the effect of 24 weeks of treatment of GTx-024 on maximal power production as assessed by inertial-load cycle ergometry | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Power Production | Describe the effect of 12 weeks of treatment of GTx-024 on maximal power production as assessed by inertial-load cycle ergometry | 12 Weeks | 
| Lean Body Mass | Describe the effect of 24 weeks of treatment of GTx-024 on lean body mass (LBM) as assessed by CT images of the lumbar region from L3 to the iliac crest | 24 Weeks | 
| Lean Body Mass | Describe the effect of 12 weeks of treatment of GTx-024 on LBM as assessed by CT images of the lumbar region from L3 to the iliac crest | 12 Weeks | 
| Maximal Power Production, Scaled to Total Body Mass | Describe the effect of 24 weeks of treatment of GTx-024 on maximal power production scaled (Watts/kilogram) to total body mass (TBM), as assessed by inertial-load cycle ergometry | 24 Weeks | 
| Maximal Power Production, Scaled to Lean Body Mass | Describe the effect of 24 weeks of treatment of GTx-024 on maximal power production scaled (Watts/kilogram) to LBM, as assessed by inertial-load cycle ergometry | 24 Weeks | 
| Optimal Pedaling Rate | Describe the effect of 24 weeks of treatment of GTx-024 on optimal pedaling rate | 24 Weeks |