What side effects are associated with this type of intervention?

Common treatments for hormone receptor-positive, HER2-negative breast cancer, such as alpelisib, capivasertib, and fulvestrant, have specific side effects. Alpelisib often causes hyperglycemia, rash, diarrhea, and liver enzyme abnormalities. Capivasertib can lead to diarrhea, nausea, vomiting, and hyperglycemia. Fulvestrant's side effects include injection site pain, nausea, and fatigue. The combination of these drugs with Evexomostat is being studied to mitigate hyperglycemia and enhance anti-tumor efficacy.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that are similar to the combination being studied with Evexomostat. Alpelisib (Piqray) is an FDA-approved PI3K inhibitor used in combination with fulvestrant for the treatment of HR-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer. Fulvestrant (Faslodex) is an estrogen receptor antagonist used in various combinations for HR-positive metastatic breast cancer. While capivasertib is still under investigation, it is a promising AKT inhibitor being studied in combination with other agents for similar indications. These treatments aim to target specific pathways involved in cancer growth and progression, similar to the approach being evaluated with Evexomostat to mitigate hyperglycemia and enhance anti-tumor efficacy.

What other types of research exist?

Promising alternatives to Evexomostat (SDX-7320) for breast cancer patients include the combination of alpelisib or capivasertib with other novel agents that have shown efficacy in clinical trials. One such alternative is the combination of alpelisib with endocrine therapy (e.g., letrozole or fulvestrant) which has demonstrated significant efficacy in HR+, HER2- advanced breast cancer with PIK3CA mutations. Another potential alternative is the use of capivasertib in combination with fulvestrant, which has shown promising results in clinical trials for similar patient populations. These combinations aim to target the PI3K/AKT pathway effectively while managing side effects such as hyperglycemia.

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Evexomostat + Alpelisib + Fulvestrant for Breast Cancer (Amelia-1 Trial)

Phase 1 & 2

Recruiting

Research Sponsored by SynDevRx, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient has identified PIK3CA mutation status using a FDA-approved test, as determined either during Screening or was previously determined to have the mutation as evidenced by written documentation.

Patient has an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤1.

Must not have

Patient has received prior PI3K/Akt/mTOR inhibitor or fulvestrant treatment

Patient has inflammatory breast cancer at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48 months

Awards & highlights

Summary

This trial tests a new drug combination for post-menopausal women with a specific type of advanced breast cancer. It aims to see if the new drug can reduce side effects and improve the effectiveness of existing treatments. The treatment works by blocking proteins and hormones that help cancer grow and by managing side effects like high blood sugar.

Who is the study for?

This trial is for adult women with advanced HR+/HER2- breast cancer, specifically those who have a PIK3CA mutation and are postmenopausal. Participants should not have brain malignancies or sensitivities to the drugs being tested, nor should they have uncontrolled diabetes or previous treatments with similar drugs.

What is being tested?

The study tests a combination of three drugs: Evexomostat, Alpelisib, and Fulvestrant in women with a specific gene mutation linked to aggressive breast cancer. It aims to see if Evexomostat can reduce high blood sugar caused by Alpelisib and improve its effectiveness against tumors.

What are the potential side effects?

Common side effects from Evexomostat include fatigue, decreased appetite, constipation, nausea, and diarrhea. The combination treatment may also cause hyperglycemia (high blood sugar), which this trial seeks to manage.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has a PIK3CA mutation confirmed by an FDA-approved test.

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I am fully active or can carry out light work.

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My cancer can be measured by scans or I have a specific type of bone lesion.

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My breast cancer is advanced and cannot be cured with surgery or radiation.

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My breast cancer is hormone receptor positive and HER2 negative.

Exclusion Criteria

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

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I have been treated with PI3K/Akt/mTOR inhibitors or fulvestrant.

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I have been diagnosed with inflammatory breast cancer.

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I have a brain tumor or brain metastasis as confirmed by my doctor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 48 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Hyperglycemic Events

Incidence of Adverse Events

Secondary study objectives

Adiponectin activity

Angiogenic activity (VEGFC)

Pathologic Neovascularization

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: EvexomostatExperimental Treatment1 Intervention

Each subject will receive repeat doses (C1, C2...) for 28-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria is met.

0 / 8Eligibility 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

Common treatments for breast cancer, such as alpelisib, capivasertib, and fulvestrant, work by targeting specific pathways crucial for cancer cell survival and proliferation. Alpelisib inhibits the PI3K pathway, capivasertib targets the AKT pathway, and fulvestrant degrades the estrogen receptor. These mechanisms are vital as they directly interfere with the cancer cells' ability to grow and survive. The combination of these treatments with Evexomostat, which helps manage hyperglycemia, not only enhances the anti-tumor efficacy but also improves the overall tolerability of the treatment, offering a more effective and manageable option for breast cancer patients.

Effect of Capivasertib in Patients With an AKT1 E17K-Mutated Tumor: NCI-MATCH Subprotocol EAY131-Y Nonrandomized Trial.An evidence-based review of the outcome of fulvestrant plus a targeted agent versus fulvestrant alone in treating hormone receptor-positive endocrine therapy-resistant metastatic breast cancer.An Experimental Analysis of the Molecular Effects of Trastuzumab (Herceptin) and Fulvestrant (Falsodex), as Single Agents or in Combination, on Human HR+/HER2+ Breast Cancer Cell Lines and Mouse Tumor Xenografts.