Elacestrant + Onapristone for Advanced Breast Cancer
(ELONA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial is testing a combination of two drugs, elacestrant and onapristone, to treat a specific type of advanced breast cancer. Elacestrant is a new drug that has shown effectiveness in patients with breast cancer that has not responded to previous treatments. The drugs work by blocking hormones that help the cancer grow.
Do I have to stop taking my current medications for the trial?
The trial requires that you stop taking certain medications before starting. Specifically, you must not take strong or moderate inducers or inhibitors of CYP3A4 within 14 days, herbal preparations within 7 days, and investigational anti-cancer therapy within 21 days before the trial. Please consult with the trial team for guidance on your specific medications.
Is the combination of Elacestrant and Onapristone safe for humans?
Elacestrant, also known as Orserdu, has been approved for treating certain types of advanced breast cancer and is generally well tolerated, with common side effects being upper gastrointestinal symptoms (like nausea or stomach upset). However, specific safety data for the combination of Elacestrant and Onapristone is not provided in the available research.12345
What makes the drug Elacestrant + Onapristone unique for advanced breast cancer?
Elacestrant is a novel oral drug that works by degrading estrogen receptors in breast cancer cells, which is different from traditional endocrine therapies that often face resistance. It is particularly beneficial for patients with specific ESR1 mutations, offering a new option for those who have progressed after other treatments.12346
What data supports the effectiveness of the drug Elacestrant + Onapristone for advanced breast cancer?
Elacestrant has shown effectiveness in treating advanced breast cancer by binding to estrogen receptors in cancer cells, which helps stop tumor growth, especially in patients with specific genetic mutations. Onapristone has also shown promise in breast cancer treatment by blocking progesterone receptors, leading to tumor responses in some patients.23478
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1b Treatment
Open-label phase to determine the recommended Phase 2 dose (RP2D) of onapristone and elacestrant
Phase 2 Treatment
Evaluate the efficacy and safety of elacestrant in combination with onapristone in patients with ER+/PgR+/HER2- advanced/metastatic breast cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Elacestrant
- Onapristone
Elacestrant is already approved in United States, European Union for the following indications:
- ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
- ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Context Therapeutics Inc.
Lead Sponsor