NCT04738292

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

A Phase II Trial of OnapriStone in CoMbInation With FuLvestrant for Patients With ER-positive, and HER2-negative Metastatic Breast Cancer After Progression on Endocrine Therapy and CDK 4/6 Inhibitors

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ER-positive Breast Cancer
• HER2-negative Breast Cancer
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	Onapristone	Onapristone is a type I antiprogestin which prevents the PgR from dimerizing and blocks ligand induced protein kinase-mediated phosphorylation of the PgR.
DRUG	Fulvestrant	Fulvestrant binds, blocks and degrades the ER, completely inhibiting ER signaling.

Timeline

• Start date: 2021-10-05
• Primary completion: 2023-04-03
• Completion: 2023-05-15
• First posted: 2021-02-04
• Last updated: 2024-05-03
• Results posted: 2024-05-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study