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

NCT06938711 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2025-04-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Context Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-30
Primary Completion
2023-11-30
Completion
2023-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06938711 on ClinicalTrials.gov