Status:
WITHDRAWN
A Rollover Protocol of Elacestrant, in Combination With Onapristone, for Patients With ER+, PR+, HER2- Advanced or Metastatic Breast Cancer
Lead Sponsor:
Context Therapeutics Inc.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief 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 onapriston...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06938711
Start Date
June 1 2023
End Date
December 1 2023
Last Update
April 22 2025
Active Locations (1)
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1
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203