NCT05618613

Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer

An Open-Label, Phase 1b-2 Study of Elacestrant, in Combination With Onapristone in Patients With Estrogen Receptor-Positive, Progesterone Receptor-Positive, HER2-negative Advanced or Metastatic Breast Cancer (ELONA)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Context Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, Phase 1b-2 study of elacestrant in combination with onapristone in patients with advanced/metastatic ER+/PgR+/HER2- breast cancer.

Detailed description

This is a multicenter, phase 1b-2 trial. The phase 1b part of the trial is open label and aims to determine the recommended Phase 2 dose (RP2D) of onapristone and elacestrant when administered together. The Phase 2 part of the trial will evaluate the efficacy and safety of this combination in patients with ER+/PgR+/HER2- advanced/metastatic breast cancer after prior therapy with a CDK4/6 inhibitor.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Elacestrant	Elacestrant 200mg, 300mg, or 400mg once daily oral dosing in cycles of 28 days.
DRUG	Onapristone	Onapristone 40mg or 50mg twice daily oral dosing in cycles of 28 days.

Timeline

• Start date: 2022-12-02
• Primary completion: 2023-06-23
• Completion: 2023-06-23
• First posted: 2022-11-16
• Last updated: 2025-05-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study