NCT06938711

A Rollover Protocol of Elacestrant, in Combination With Onapristone, for Patients With ER+, PR+, HER2- Advanced or Metastatic Breast Cancer

A Rollover Protocol of Elacestrant, in Combination With Onapristone, for Patients With Estrogen Receptor-Positive, Progesterone Receptor-Positive, HER2-negative Advanced or Metastatic Breast Cancer

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Context Therapeutics Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a rollover study for patients enrolled in the discontinued ELONA clinical trial (ONA-XR-103) with the primary objective to characterize the safety of elacestrant in combination with onapristone either alone or in combination.

Conditions

• Breast Cancer

Interventions

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

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-11-01
• Completion: 2023-12-01
• First posted: 2025-04-22
• Last updated: 2025-04-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study