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Clinical Trial Summary

STAGE 1: To determine the safety of enobosarm 9 mg once daily (QD) used in combination with a CDK 4/6 inhibitor [Verzenio® (abemaciclib) tablets, for oral use, 150 mg twice daily (BID)]. STAGE 2: To demonstrate the efficacy and safety of enobosarm 9 mg QD in combination with abemaciclib 150 mg BID (Enobosarm Combination Group) versus Estrogen Blocking Agent (Control Treated Group) in the treatment of estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-), androgen receptor positive (AR+) with a AR% nuclei staining ≥40% metastatic breast cancer that have previously experienced disease progression on an estrogen blocking agent plus CDK 4/6 inhibitor (palbociclib) as measured by radiographic progression free survival (rPFS).

Clinical Trial Description

STAGE 1: This is an open-label safety study of enobosarm 9 mg QD coadministered with a CDK 4/6 inhibitor (abemaciclib), 150 mg BID. STAGE 2: This study is a multicenter, randomized, open-label, two treatment arm, efficacy and safety study. Subjects will be randomized to the two treatment arms (Enobosarm Combination Group versus Control Treated Group) in a 2:1 fashion. The determination of the treatment to be used in the control arm will be declared prior to randomization. If first line of therapy for metastatic breast cancer is a non-steroidal AI plus palbociclib, then the patient will be randomized to either enobosarm + abemaciclib inhibitor OR fulvestrant. If first line of therapy for metastatic breast cancer is fulvestrant plus palbociclib, then the patient will be randomized to either enobosarm + abemaciclib OR AI (steroidal or non-steroidal). If the patient is randomized to the Control Treated Group to receive steroidal AI, exemestane. The patient may receive exemestane with or without everolimus. The primary efficacy endpoint of the study will be the median rPFS. Subjects will continue study treatment until disease progression confirmed by blinded independent central reader (BICR) is observed. A safety follow up visit will occur approximately 30 days after last dose of study drug. After radiographic progression (by RECIST 1.1) is observed in the subjects in the Control Treated Group, the subjects will be crossed over to enobosarm treatment (9 mg per day) plus abemaciclib (150 mg BID). Treatment will continue in this population (Enobosarm Extension Group (EEG)) until radiographic progression (by RECIST 1.1) is observed. The efficacy data analysis for the EEG will be completely separate from the main portion of the study. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05065411
Study type Interventional
Source Veru Inc.
Contact Barnette
Phone 800-606-9382
Email [email protected]
Status Not yet recruiting
Phase Phase 2
Start date November 30, 2021
Completion date January 30, 2024

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