A Rollover Protocol of Elacestrant, in Combination With Onapristone, for Patients With ER+, PR+, HER2- Advanced or Metastatic Breast Cancer
NCT ID: NCT06938711
Last Updated: 2025-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2023-06-30
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Elacestrant / Onapristone
Elacestrant and Onapristone combination
Elacestrant
Elacestrant 200mg once daily oral dosing in cycles of 28 days.
Onapristone
Onapristone 40mg twice daily oral dosing in cycles of 28 days.
Interventions
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Elacestrant
Elacestrant 200mg once daily oral dosing in cycles of 28 days.
Onapristone
Onapristone 40mg twice daily oral dosing in cycles of 28 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Context Therapeutics Inc.
INDUSTRY
Responsible Party
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Locations
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Sarah Cannon Research Institute
Nashville, Tennessee, United States
Countries
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Other Identifiers
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ONA-XR-104
Identifier Type: -
Identifier Source: org_study_id
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