Clinical trial · Interventional
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
NCT06938711CI-TRIAL-00088760withdrawnPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Change in corporate strategy.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Elacestrant | Drug | Elacestrant | ALIAS |
| Onapristone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Elacestrant / Onapristone
- description
- Elacestrant and Onapristone combination
- interventionNames
- Drug: Elacestrant
- Drug: Onapristone
Primary outcomes (1)
- measure
- Characterize the safety of elacestrant in combination with onapristone.
- timeFrame
- 7 months
- description
- Monitor the treatment-related adverse events as assessed by CTCAE v4.0
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.