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

Context Therapeutics

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Breast Cancer

Treatments

Drug: Elacestrant

Drug: Onapristone

Study type

Interventional

Funder types

Industry

Identifiers

NCT06938711

ONA-XR-104

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.