← Back to Search

Selective Estrogen Receptor Downregulator

Onapristone for Breast Cancer

Phase 2
Waitlist Available
Led By Kari B Wisinski, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a new drug to see if it works well with another existing drug to treat metastatic breast cancer.

Eligible Conditions
  • Breast Cancer
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Disease Control Rate (DCR)
Duration of Response
Incidence of Adverse Events
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Onapristone In Combination with FulvestrantExperimental Treatment2 Interventions
All participants will receive onapristone 50 mg p.o. BID (twice) daily and fulvestrant (500 mg) intramuscular injection on days 1, 15 (cycle 1), then two weeks later (cycle 2, day1), then once every 28 days thereafter. A cycle is defined as 28 days. There will be no breaks between dosing cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Onapristone
2020
Completed Early Phase 1
~10
Fulvestrant
2011
Completed Phase 3
~3690

Find a Location

Who is running the clinical trial?

Context TherapeuticsIndustry Sponsor
2 Previous Clinical Trials
34 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,167,376 Total Patients Enrolled
36 Trials studying Breast Cancer
38,519 Patients Enrolled for Breast Cancer
Context Therapeutics Inc.Industry Sponsor
4 Previous Clinical Trials
115 Total Patients Enrolled
1 Trials studying Breast Cancer
67 Patients Enrolled for Breast Cancer

Media Library

Fulvestrant (Selective Estrogen Receptor Downregulator) Clinical Trial Eligibility Overview. Trial Name: NCT04738292 — Phase 2
Breast Cancer Research Study Groups: Onapristone In Combination with Fulvestrant
Breast Cancer Clinical Trial 2023: Fulvestrant Highlights & Side Effects. Trial Name: NCT04738292 — Phase 2
Fulvestrant (Selective Estrogen Receptor Downregulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04738292 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical trial actively seeking participants?

"Clinicaltrials.gov's records indicate that this clinical trial is currently in search of candidates, after having been published on October 5th 2021 and last revised on July 7th 2022."

Answered by AI

What medicinal purposes does Onapristone typically serve?

"Endocrine therapy, breast cancer, and certain diseases can all be managed using onapristone."

Answered by AI

What other empirical research has been conducted using Onapristone?

"Presently, there are 136 active clinical trials surveying the impacts of Onapristone with 32 studies in their final stage. While some trails for this drug may be found in Shanghai, a total of 5812 locations across the world have opened up opportunities to participate in these research projects."

Answered by AI

How many individuals are actively involved in this research trial?

"Affirmative. Information posted on clinicaltrials.gov reveals that this research project is in the process of recruiting patients, initially published on October 5th 2021 and most recently updated July 7th 2022. A total of 39 participants are needed from 2 medical centres."

Answered by AI

Has Onapristone been granted authorization by the FDA?

"Considering the Phase 2 status of this trial, our team at Power assigned Onapristone a score of 2 for safety. This indicates that there is evidence supporting its security but no clinical data has been provided in regards to efficacy."

Answered by AI
~3 spots leftby Apr 2025