NCT04738292View on ClinicalTrials.gov

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

PHASE2TerminatedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

October 5, 2021

Primary Completion Date

April 3, 2023

Study Completion Date

May 15, 2023

Conditions
ER-positive Breast CancerHER2-negative Breast CancerMetastatic Cancer
Interventions
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.

Trial Locations (2)

53226

Medical College of Wisconsin, Milwaukee

53705

University of Wisconsin Carbone Cancer Center, Madison

Sponsors

Collaborators (1)

Context Therapeutics Inc.
All Listed Sponsors
collaborator

Context Therapeutics Inc.

INDUSTRY

lead

University of Wisconsin, Madison

OTHER

NCT04738292 - Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study) | Biotech Hunter | Biotech Hunter