What side effects are associated with this type of intervention?

Common side effects of breast cancer treatments similar to Elacestrant (Selective Estrogen Receptor Degrader) and Onapristone (Progesterone Receptor Antagonist) include hot flashes, vaginal dryness, and an increased risk of blood clots and endometrial cancer for estrogen receptor inhibitors. Progesterone receptor antagonists can cause fatigue, nausea, and changes in liver enzymes. Both treatments may also lead to bone density loss and cardiovascular issues.

What prior FDA approvals exist?

The FDA has approved several hormone therapies for breast cancer, particularly those targeting estrogen and progesterone receptors. Fulvestrant, a Selective Estrogen Receptor Degrader (SERD), is approved for hormone receptor-positive metastatic breast cancer. Tamoxifen and aromatase inhibitors like anastrozole and letrozole are also widely used for their estrogen receptor antagonistic effects. While there are no specific FDA-approved progesterone receptor antagonists for breast cancer, hormone therapies targeting these pathways remain a cornerstone of treatment for hormone receptor-positive breast cancer.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include: 1) Giredestrant, a next-generation oral SERD showing efficacy in ER+ breast cancer. 2) Camizestrant, another oral SERD with positive clinical trial results. 3) Abemaciclib, a CDK4/6 inhibitor, which has shown effectiveness in combination with endocrine therapy. 4) Alpelisib, a PI3K inhibitor, particularly for patients with PIK3CA-mutated breast cancer. These alternatives represent advancements in targeting hormone receptor pathways and other molecular targets in breast cancer.

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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.

Must not have

Females of childbearing potential who do not use a highly effective method of contraception.

Inability to take oral medication, or history of malabsorption syndrome or any other uncontrolled gastrointestinal condition.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1.5 years

Awards & highlights

No Placebo-Only Group

Summary

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.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is ER and PgR positive and HER2 negative, according to specific guidelines.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not using a highly effective birth control method.

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I cannot take pills by mouth or have a condition affecting how my body absorbs food.

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I have metastatic breast cancer and haven't received any treatment yet.

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I have previously been treated with elacestrant, onapristone, or chemotherapy for cancer that has spread.

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I agree to use contraception or not donate sperm.

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I do not have any severe ongoing infections.

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I have new or active brain or spinal cord cancer spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

2019

Completed Phase 3

~560

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Elacestrant, a Selective Estrogen Receptor Degrader (SERD), binds to estrogen receptors on cancer cells, leading to their degradation and preventing estrogen from promoting cancer cell growth. Onapristone, a Progesterone Receptor Antagonist, blocks progesterone receptors, inhibiting the growth-promoting effects of progesterone on cancer cells. These treatments are crucial for breast cancer patients with hormone receptor-positive tumors as they target the hormonal pathways driving cancer progression, offering a more tailored and potentially effective treatment option.