Overview

Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study)

Status:
Recruiting

Trial end date:
2025-03-01

Target enrollment:

Participant gender:

Summary

A phase II single-arm trial of onapristone in combination with fulvestrant for women and men with ER-positive, PgR-positive or negative and HER2-negative locally advanced or metastatic breast cancer after progression on aromatase and CDK4/6 inhibitors. The study will enroll up to 39 participants.

Phase:

Phase 2

Details

Lead Sponsor:

University of Wisconsin, Madison

Collaborator:

Context Therapeutics

Treatments:

Fulvestrant
Onapristone