4 Participants Needed

Elacestrant + Onapristone for Advanced Breast Cancer

(ELONA Trial)

Recruiting at 2 trial locations
PM
Overseen ByPriya Marreddy
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Context Therapeutics Inc.
Must be taking: Goserelin, Triptorelin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

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.
See 3 more

Exclusion 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 not had cancer besides my current one in the last 3 years.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1b Treatment

Open-label phase to determine the recommended Phase 2 dose (RP2D) of onapristone and elacestrant

9 months

Phase 2 Treatment

Evaluate the efficacy and safety of elacestrant in combination with onapristone in patients with ER+/PgR+/HER2- advanced/metastatic breast cancer

1.5 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

21 months

What Are the Treatments Tested in This Trial?

Interventions

  • Elacestrant
  • Onapristone
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Elacestrant / OnapristoneExperimental Treatment2 Interventions
Elacestrant and Onapristone combination

Elacestrant is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Orserdu for:
  • ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer
🇪🇺
Approved in European Union as Orserdu for:
  • 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

Trials
7
Recruited
260+

Published Research Related to This Trial

Elacestrant (RAD-1901) is a selective estrogen receptor degrader that was approved by the USFDA for treating ER+ HER2-positive breast cancer, demonstrating anticancer activity in both laboratory and animal models.
The review discusses Elacestrant's development, including its medicinal chemistry, mechanism of action, and safety profile based on clinical trial data, highlighting its potential as an effective treatment option.
Elacestrant: a new FDA-approved SERD for the treatment of breast cancer.Bhatia, N., Thareja, S.[2023]
Elacestrant (ORSERDU™) is a newly approved oral medication for treating advanced or metastatic breast cancer in postmenopausal women and adult men with specific estrogen receptor mutations, following at least one line of endocrine therapy.
The drug specifically targets estrogen receptor-positive, HER2-negative breast cancer, and its approval in the USA marks a significant milestone in its development, with ongoing regulatory assessments in the EU.
Elacestrant: First Approval.Hoy, SM.[2023]
Elacestrant, an oral selective estrogen receptor downregulator, was approved by the FDA in January 2023 for treating hormone receptor positive (HR+) HER2- advanced breast cancer, showing improved progression-free survival in patients with ESR1 mutations who had previously failed treatment with CDK 4/6 inhibitors and endocrine therapy.
Clinical trials indicate that elacestrant has a safety profile comparable to existing endocrine therapies and provides an effective alternative treatment option, especially for patients who have not responded to standard therapies.
Elacestrant for ER-Positive HER2-Negative Advanced Breast Cancer.Hageman, E., Lussier, ME.[2023]

Citations

Evaluating Elacestrant in the Management of ER-Positive, HER2-Negative Advanced Breast Cancer: Evidence to Date. [2023]
Elacestrant: a new FDA-approved SERD for the treatment of breast cancer. [2023]
Onapristone, a progesterone receptor antagonist, as first-line therapy in primary breast cancer. [2022]
Elacestrant: First Approval. [2023]
Phase I study of onapristone, a type I antiprogestin, in female patients with previously treated recurrent or metastatic progesterone receptor-expressing cancers. [2019]
Elacestrant for ER-Positive HER2-Negative Advanced Breast Cancer. [2023]
7.United Arab Emiratespubmed.ncbi.nlm.nih.gov
First Approval of Elacestrant as a Selective Estrogen Receptor Degrader for the Treatment of Metastatic Breast Cancer. [2023]
Pharmacokinetic and Pharmacodynamic Studies of Elacestrant, A Novel Oral Selective Estrogen Receptor Degrader, in Healthy Post-Menopausal Women. [2021]
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