Elacestrant + Onapristone for Advanced Breast Cancer

(ELONA Trial)

Recruiting at 2 trial locations

Overseen By Priya Marreddy

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Context Therapeutics Inc.

Must be taking: Goserelin, Triptorelin

Must not be taking: CYP3A4 inducers/inhibitors, Herbal meds

Disqualifiers: CNS metastases, Chemotherapy, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

4 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 2 3 4 6}

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. ^{2 3 4 7 8}

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.

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.

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?

Group I: Elacestrant / Onapristone Experimental Treatment 2 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elacestrant for ER-Positive HER2-Negative Advanced Breast Cancer. Hageman, E., Lussier, ME.[2023]

Elacestrant was approved by the FDA for treating advanced or metastatic breast cancer in postmenopausal women and adult men with specific estrogen receptor mutations, highlighting its targeted approach for patients who have not responded to prior endocrine therapy.

The summary includes important details about elacestrant's mechanism of action and safety profile, which are crucial for understanding its role in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Approval of Elacestrant as a Selective Estrogen Receptor Degrader for the Treatment of Metastatic Breast Cancer. De, SK.[2023]

Elacestrant, a selective estrogen receptor degrader, was found to be safe and well tolerated in a study involving 140 postmenopausal women, with doses up to 1000 mg daily not reaching the maximum tolerated dose.

The drug showed good oral bioavailability and a half-life of 27 to 47 hours, allowing for once-daily dosing, while effectively engaging estrogen receptors and demonstrating some ability to cross the blood-brain barrier.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and Pharmacodynamic Studies of Elacestrant, A Novel Oral Selective Estrogen Receptor Degrader, in Healthy Post-Menopausal Women. Conlan, MG., de Vries, EFJ., Glaudemans, A., et al.[2021]

Citations

1. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluating Elacestrant in the Management of ER-Positive, HER2-Negative Advanced Breast Cancer: Evidence to Date. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Elacestrant: a new FDA-approved SERD for the treatment of breast cancer. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Onapristone, a progesterone receptor antagonist, as first-line therapy in primary breast cancer. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Elacestrant: First Approval. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Phase I study of onapristone, a type I antiprogestin, in female patients with previously treated recurrent or metastatic progesterone receptor-expressing cancers. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Elacestrant for ER-Positive HER2-Negative Advanced Breast Cancer. [2023]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

First Approval of Elacestrant as a Selective Estrogen Receptor Degrader for the Treatment of Metastatic Breast Cancer. [2023]

8. France pubmed.ncbi.nlm.nih.gov

Pharmacokinetic and Pharmacodynamic Studies of Elacestrant, A Novel Oral Selective Estrogen Receptor Degrader, in Healthy Post-Menopausal Women. [2021]