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WithdrawnNCT06938711Updated Apr 22, 2025

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

A Phase 1/2 interventional study of Elacestrant and Onapristone in Breast Cancer, sponsored by Context Therapeutics Inc.. Withdrawn at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-22.

Sponsored by Context Therapeutics Inc. · Phase 1/2, Interventional, and Treatment

Why this study was withdrawn
Change in corporate strategy.
Phase
Phase 1/2
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

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.

02

Conditions studied

  • Breast Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

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Lead sponsor

Context Therapeutics Inc. is the lead sponsor of 5 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Patient is currently enrolled in the ELONA clinical study (ONA-XR-103) and receiving onapristone or elacestrant, either alone or in combination.
  • Patient is currently benefiting from the treatment in the ELONA clinical study, as determined by the investigator.
  • Patient currently has no evidence of progressive disease, as determined by the investigator.

Exclusion criteria

Exclusion Criteria:

  • Pregnant or nursing (lactating) women.
  • Female patients of childbearing potential (e.g., are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception, throughout the study and for up to 30 days after stopping study treatment.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Elacestrant / Onapristone

    Elacestrant and Onapristone combination

    Drug: Elacestrant · Drug: Onapristone

Interventions

  • DrugElacestrant

    Elacestrant 200mg once daily oral dosing in cycles of 28 days.

    Also known as: RAD1901

  • DrugOnapristone

    Onapristone 40mg twice daily oral dosing in cycles of 28 days.

06

What researchers measure

Primary outcomes

  1. Characterize the safety of elacestrant in combination with onapristone.

    Monitor the treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 7 months

07

Study locations

1 site
  • Sarah Cannon Research Institute
    Nashville, Tennessee 37203, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06938711
Lead sponsor
Context Therapeutics Inc.
Responsible party
Sponsor
First posted
Apr 22, 2025
Start date
Jun 2023 (estimated)
Primary completion
Nov 2023 (estimated)
Completion
Dec 2023 (estimated)
Last update
Apr 22, 2025

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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