Breast Cancer
Conditions
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 onapristone either alone or in combination.
Interventions
DRUGElacestrant
Elacestrant 200mg once daily oral dosing in cycles of 28 days.
DRUGOnapristone
Onapristone 40mg twice daily oral dosing in cycles of 28 days.
Sponsors
Context Therapeutics Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterize the safety of elacestrant in combination with onapristone. | 7 months | Monitor the treatment-related adverse events as assessed by CTCAE v4.0 |
Countries
United States
Outcome results
None listed