Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer (VERU-024)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05065411 |
Recruitment Status :
Terminated
(Business decision)
First Posted : October 4, 2021
Last Update Posted : February 26, 2024
|
Tracking Information | |||||
---|---|---|---|---|---|
First Submitted Date ICMJE | September 21, 2021 | ||||
First Posted Date ICMJE | October 4, 2021 | ||||
Last Update Posted Date | February 26, 2024 | ||||
Actual Study Start Date ICMJE | April 11, 2022 | ||||
Actual Primary Completion Date | October 19, 2023 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Primary endpoint for the study is the median progression free survival (PFS) in the Enobosarm Combination Group compared to the Control Treatment Group in patients with AR% nuclei staining ≥40%. Progression will be defined based on RECIST 1.1 criteria [ Time Frame: Day 1 to Day 300 ] STAGE 1: To determine the safety of enobosarm 9 mg once daily (QD) used in combination with abemaciclib tablets, for oral use, 150 mg twice daily (BID)].
STAGE 2: To demonstrate the efficacy of enobosarm in combination with abemaciclib (Enobosarm Combination Group) versus an estrogen blocking agent, (non-steroidal AI, steroidal AI (exemestane with or without everolimus) or fulvestrant Control Treatment Group) in the treatment of AR+ER+HER2 (AR% nuclei staining ≥40%) metastatic breast cancer as measured by PFS according to RECIST 1.1.
|
||||
Original Primary Outcome Measures ICMJE |
Primary endpoint for the study is the median radiographic progression free survival (rPFS) in the Enobosarm Combination Group compared to the Control Treated Group in patients with AR% nuclei staining ≥40%. Progression will be defined based on RECIST 1.1 [ Time Frame: Day 1 to Day 300 ] 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).
|
||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Objective Response Rate (ORR), proportion of subjects with a best tumor response of ORR (partial response [PR] or complete response [CR]) on study [ Time Frame: Day 1 to Day 300 ] Objective Response Rate (ORR), proportion of subjects with a best tumor response of ORR (partial response [PR] or complete response [CR]) on study
|
||||
Original Secondary Outcome Measures ICMJE |
Assess the rPFS in all patients and in patients with ≥10%, ≥20%, and ≥60% AR% nuclei staining [ Time Frame: Day 1 to Day 300 ] Assess the rPFS in all patients and in patients with ≥10%, ≥20%, and ≥60% AR% nuclei staining
|
||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer | ||||
Official Title ICMJE | P3 Efficacy Evaluation of Enobosarm in Combo With Abemaciclib Compared to Estrogen Blocking Agent for 2nd Line Treatment of ER+HER2- MBC in Patients Who Have Shown Previous Disease Progression on an Estrogen Blocking Agent Plus Palbociclib | ||||
Brief Summary | STAGE 1: To determine the safety of enobosarm 9 milligram (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 Treatment 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 (palbociclib) as measured by progression free survival (PFS) according to RECIST 1.1 criteria. |
||||
Detailed 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 Treatment Group) in a 1:1 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 was a non-steroidal AI plus palbociclib, then the patient will be randomized to either enobosarm + abemaciclib OR fulvestrant. If first line of therapy for metastatic breast cancer was 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 Treatment 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 PFS as defined by RECIST 1.1. 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. Long term survival follow up - every 30 days after last dose of study drug for 1 year and then every 90 days thereafter. |
||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Open Label two treatment arm Masking: Single (Outcomes Assessor)Masking Description: Only the central radiologist readers will be blinded to treatment assignments Primary Purpose: Treatment
|
||||
Condition ICMJE | Metastatic Breast Cancer | ||||
Intervention ICMJE |
|
||||
Study Arms ICMJE |
|
||||
Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
5 | ||||
Original Estimated Enrollment ICMJE |
186 | ||||
Actual Study Completion Date ICMJE | January 9, 2024 | ||||
Actual Primary Completion Date | October 19, 2023 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: Subjects accepted for this study must:
Subject must agree to use acceptable methods of contraception:
Exclusion Criteria: Any of the following conditions are cause for exclusion from the study:
NOTE: Subjects may have received 1 course of chemotherapy in the adjuvant or neoadjuvant setting would not count as a line of therapy.
|
||||
Sex/Gender ICMJE |
|
||||
Ages ICMJE | 18 Years to 100 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT05065411 | ||||
Other Study ID Numbers ICMJE | V2000701 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
|
||||
IPD Sharing Statement ICMJE |
|
||||
Current Responsible Party | Veru Inc. | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Veru Inc. | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
|
||||
PRS Account | Veru Inc. | ||||
Verification Date | February 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |