Efficacy Evaluation of Sabizabulin Monotherapy Versus Active Control for Treatment of ER+HER2- Metastatic Breast Cancer

Recruiting in Palo Alto (17 mi)

+26 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Veru Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

To demonstrate the efficacy of sabizabulin in the treatment of ER+HER2- metastatic breast cancer (MBC) as measured by progression free survival (PFS) by RECIST v1.1.

Research Team

Barnette

Principal Investigator

Veru Inc.

Eligibility Criteria

Inclusion Criteria

You are a woman who is over 55 years old and has not had a menstrual period for at least one year.

You are under 55 years old and have had both ovaries surgically removed.

Subject is willing to comply with the requirements of the protocol through the end of the study

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Exclusion Criteria

Known hypersensitivity or allergy to sabizabulin or colchicine

Creatinine clearance < 60 mL/min as measured using the Cockcoft Gault formula (patients with mild and moderate renal failure are not excluded from participation in this study)

QT interval corrected by Fridericia's formulation >480 ms

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Treatment Details

Interventions

Sabizabulin (Microtubule Inhibitor)

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Sabizabulin Treatment GroupExperimental Treatment1 Intervention

Subjects in the Sabizabulin Treatment Group will receive sabizabulin 32mg each day by mouth until disease progression is observed and confirmed by BICR.

Group II: Control Treatment GroupActive Control1 Intervention

Subjects in the Control Treatment Group will receive an ER targeted therapy limited to exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator (SERM) approved for the treatment of breast cancer and is part of the standard of care at the clinical study site until disease progression is observed and confirmed by BICR. The investigator decision of which comparator treatment will be used will be made prior to randomization.