Statement: There was less than a 5% difference in the Percentage of Participants With Objective Response in the GTx-024 9 mg and GTx-024 18 mg group in the primary trial.
Primary_evidence: Outcome Measurement:    Clinical Benefit Rate, in Centrally Confirmed Androgen Receptor (AR)+ Subjects   To estimate the clinical benefit rate (defined as complete response, partial response, or stable disease) according to RECIST 1.1, in subjects with estrogen receptor positive/androgen receptor positive (ER+/AR+) BC who have centrally confirmed AR+ status. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR; Clinical Benefit Rate (CBR)= CR + PR + SD.   Time frame: 24 weeks Results 1:    Arm/Group Title: GTx-024 9 mg   Arm/Group Description: Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 9 mg   GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate.   Overall Number of Participants Analyzed: 50   Measure Type: Number   Unit of Measure: participants  16 Results 2:    Arm/Group Title: GTx-024 18 mg   Arm/Group Description: Drug: GTx-024 GTx-024 softgel capsules will be administered once daily to a total dose of 18 mg   GTx-024: To determine whether either or both doses result in an acceptable clinical benefit rate.   Overall Number of Participants Analyzed: 52   Measure Type: Number   Unit of Measure: participants  15