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Enobosarm & Abemaciclib Combo for Metastatic Breast Cancer

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Metastatic Breast CancerEnobosarm & Abemaciclib Combo - Drug
Eligibility
18 - 100
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing the safety of a new drug, enobosarm, when used with the existing drug Verzenio. The second part of the trial is testing whether the new drug combination is more effective than just Verzenio alone in treating metastatic breast cancer.

Eligible Conditions
  • Metastatic Breast Cancer

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
LOXO-783
1
LY3484356
1
AZD9833

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Day 1 to Day 300

Day 300
Assess the rPFS in all patients and in patients with ≥10%, ≥20%, and ≥60% AR% nuclei staining
Objective Response Rate (ORR), proportion of subjects with a best tumor response of ORR (partial response [PR] or complete response [CR]) on study
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
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

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
LOXO-783
1
LY3484356
1
AZD9833

Trial Design

3 Treatment Groups

Control Treated Group
1 of 3
Control Treatment Group
1 of 3
Enobosarm Combination Group
1 of 3

Active Control

Experimental Treatment

186 Total Participants · 3 Treatment Groups

Primary Treatment: Enobosarm & Abemaciclib Combo · No Placebo Group · Phase 3

Enobosarm Combination Group
Drug
Experimental Group · 1 Intervention: Enobosarm & Abemaciclib Combo · Intervention Types: Drug
Control Treated Group
Drug
ActiveComparator Group · 1 Intervention: non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant · Intervention Types: Drug
Control Treatment Group
Drug
ActiveComparator Group · 1 Intervention: non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to day 300

Who is running the clinical trial?

Veru Inc.Lead Sponsor
9 Previous Clinical Trials
1,072 Total Patients Enrolled
2 Trials studying Metastatic Breast Cancer
410 Patients Enrolled for Metastatic Breast Cancer
BarnetteStudy ChairVeru Inc.
8 Previous Clinical Trials
1,032 Total Patients Enrolled
2 Trials studying Metastatic Breast Cancer
410 Patients Enrolled for Metastatic Breast Cancer

Eligibility Criteria

Age 18 - 100 · All Participants · 10 Total Inclusion Criteria

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References

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