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Selective Estrogen Receptor Degrader (SERD)
Elacestrant + Onapristone for Advanced Breast Cancer (ELONA Trial)
Phase 1 & 2
Waitlist Available
Research Sponsored by Context Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histopathologically or cytologically confirmed ER+, PgR+, HER2-, breast cancer, per local laboratory, as per the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (Allison et al, 2020). In the context of this trial, ER and PgR status will be considered positive if ≥10% of tumor cells demonstrate positive nuclear staining by immunohistochemistry.
ECOG performance status of 0 or 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1.5 years
Awards & highlights
ELONA Trial Summary
This trial tests a new drug combo to treat advanced breast cancer.
Who is the study for?
This trial is for adults with advanced ER+/PgR+/HER2- breast cancer who've had certain prior treatments. They must be able to take oral meds, have no uncontrolled gastrointestinal issues, and agree to contraception. Exclusions include treatment-naïve patients in the metastatic setting, recent major surgery, or active significant infections.Check my eligibility
What is being tested?
The study tests elacestrant combined with onapristone in patients with a specific type of breast cancer that has spread. It's an early-to-mid stage trial assessing safety and effectiveness of this drug combo compared to existing treatments.See study design
What are the potential side effects?
Potential side effects are not specified here but may include typical reactions seen with cancer medications such as nausea, fatigue, hormonal changes due to goserelin or triptorelin administration, and possible allergic reactions to the drugs or their components.
ELONA Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is ER and PgR positive and HER2 negative, according to specific guidelines.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
ELONA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the recommended Phase 2 dose (RP2D) of the combination of onapristone and elacestrant (Phase 1).
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).
Secondary outcome measures
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.
+10 moreELONA Trial Design
1Treatment groups
Experimental Treatment
Group I: Elacestrant / OnapristoneExperimental Treatment2 Interventions
Elacestrant and Onapristone combination
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Onapristone
2020
Completed Early Phase 1
~10
Elacestrant
2015
Completed Phase 1
~80
Find a Location
Who is running the clinical trial?
Context Therapeutics Inc.Lead Sponsor
4 Previous Clinical Trials
59 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not using a highly effective birth control method.I cannot take pills by mouth or have a condition affecting how my body absorbs food.I have a tumor that can be measured and no recent brain issues.My breast cancer is ER and PgR positive and HER2 negative, according to specific guidelines.I am 18 or older and, if female, will take goserelin, or if male, will take triptorelin as required.I have not had cancer besides my current one in the last 3 years.I have metastatic breast cancer and haven't received any treatment yet.I have previously been treated with elacestrant, onapristone, or chemotherapy for cancer that has spread.I have not had major surgery in the last 4 weeks.I agree to use contraception or not donate sperm.I do not have any severe ongoing infections.I have new or active brain or spinal cord cancer spread.I am currently taking or have recently taken certain medications.I have not been vaccinated in the week before joining the study.I am fully active or restricted in physically strenuous activity but can do light work.You are currently using alcohol or drugs in a harmful way.My blood tests show my organs and bone marrow are working well.I have hepatitis B/C or HIV with an undetectable viral load.I've been treated with specific hormone therapies for my cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Elacestrant / Onapristone
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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