Elacestrant / Onapristone for Breast Cancer

Sarah Cannon Research Institute, Nashville, TN
Breast CancerElacestrant - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial tests a new drug combo to treat advanced breast cancer.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

Study Objectives

2 Primary · 13 Secondary · Reporting Duration: 1.5 years

1.5 years
Evaluate the efficacy of elacestrant in combination with onapristone in terms of objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1 (Phase 2).
21 months
Characterize the AEs of elacestrant in combination with onapristone.
Electrocardiogram
Characterize the safety in terms of changes in clinical laboratory values of elacestrant in combination with onapristone.
Characterize the safety in terms of changes in vital sign measurements of elacestrant in combination with onapristone.
Characterize the serious adverse events (SAEs) of elacestrant in combination with onapristone.
3 years
Evaluate clinical benefit rate.
Evaluate duration of response.
Evaluate overall survival.
Evaluate progression-free survival.
9 months
Determine the recommended Phase 2 dose (RP2D) of the combination of onapristone and elacestrant (Phase 1).
Evaluate the area under the plasma concentration-time curve over the dosing interval of elacestrant as well as onapristone and their metabolites (Phase 1).
Brain Diseases, Metabolic
Brain Diseases, Metabolic
Brain Diseases, Metabolic

Trial Safety

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Elacestrant / Onapristone
1 of 1

Experimental Treatment

67 Total Participants · 1 Treatment Group

Primary Treatment: Elacestrant / Onapristone · No Placebo Group · Phase 1 & 2

Elacestrant / OnapristoneExperimental Group · 2 Interventions: Elacestrant, Onapristone · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elacestrant
2015
Completed Phase 1
~80
Onapristone
2020
Completed Early Phase 1
~10

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1.5 years

Who is running the clinical trial?

Context Therapeutics Inc.Lead Sponsor
4 Previous Clinical Trials
70 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 0 Total Inclusion Criteria

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Frequently Asked Questions

Are there still vacancies for individuals wishing to participate in this examination?

"Affirmative. Information on clinicaltrials.gov suggests that this experiment is still recruiting participants, with the first posting occurring on November 22nd 2022 and an update made December 2nd of the same year. 67 patients are needed to be recruited from 1 centre." - Anonymous Online Contributor

Unverified Answer

What is the upper limit of participants for this experiment?

"Affirmative, the information posted to clinicaltrials.gov confirms that this medical trial is open for recruitment. It was first advertised on November 22nd 2022 and its details were most recently updated December 2nd of the same year. The study requires 67 participants from 1 centre." - Anonymous Online Contributor

Unverified Answer

What outcomes are researchers hoping to realize with this investigation?

"According to Context Therapeutics Inc., the main objective of this 9 month trial is to measure the efficacy of elacestrant in combination with onapristone, as measured by Objective Response Rate (ORR) per RECIST Version 1.1 (Phase 2). Additionally, secondary metrics such as overall survival rate, clinical benefit rate and progression-free survival will also be collected and analyzed." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.