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

Context Therapeutics Inc.

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Breast Cancer

Interventions

ElacestrantDRUG

Elacestrant 200mg once daily oral dosing in cycles of 28 days.

OnapristoneDRUG

Onapristone 40mg twice daily oral dosing in cycles of 28 days.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Characterize the safety of elacestrant in combination with onapristone.

Monitor the treatment-related adverse events as assessed by CTCAE v4.0

Time frame: 7 months

Data from ClinicalTrials.gov

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