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Efficacy Evaluation of Enobosarm Monotherapy in Treatment of AR+/ER+/HER2- Metastatic Breast Cancer

NCT04869943 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-01-26

No results posted yet for this study

Summary

To demonstrate the efficacy of enobosarmin the treatment of androgen receptor positive (AR+) and estrogen receptor positive (ER+) metastatic breast cancer (MBC) as measured by radiographic progression free survival (rPFS).

Conditions

Interventions

DRUG

Enobosarm

Oral Enobosarm 9mg per day

DRUG

Exemestane

Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator (SERM)

Sponsors & Collaborators

  • Veru Inc.

    lead INDUSTRY

Principal Investigators

  • Barnette · Veru Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2024-01-09
Completion
2024-01-09
FDA Drug
Yes

Countries

  • United States
  • Poland
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04869943 on ClinicalTrials.gov