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Cancer Vaccine

Elacestrant + DC1 Vaccines for Breast Cancer

Tampa, FL

Phase 1

Recruiting

Led By Aixa Soyano Muller, MD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

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

Must have

Participants must have been previously treated with at least 1 line of endocrine therapy and a CDK 4/6 inhibitor in the metastatic setting

Participants must have adequate organ and marrow function as defined below: absolute neutrophil count ≥1,000/mcL, platelets ≥75,000/mcL, AST(SGOT)/ALT(SGPT) ≤3 fold × institutional ULN, creatinine 1.5 ≤ institutional ULN, hemoglobin (Hb) ≥ 9 g/dL, Total bilirubin < 1.5 x ULN or <3 x ULN in the presence of documented Gilbert's syndrome unconjugated hyperbilirubinemia

Must not have

Previous treatment with Elacestrant

Active, progressing or newly diagnosed CNS metastases, including leptomeningeal carcinomatosis, because systemic treatment would need to be paused for these patients

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if a new treatment combination of DC1 vaccines and elacestrant is safe and possible for patients with a specific type of advanced breast cancer.

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Who is the study for?

This trial is for individuals with hormone-positive, HER2-negative metastatic breast cancer. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be required to have a particular status of disease progression.Check my eligibility

What is being tested?

The study is testing the combination of a Dendritic Cell (DC1) vaccine targeting mutated ESR1 receptors and elacestrant, a drug for treating breast cancer. It aims to assess the safety and how doable this approach is for patients.See study design

What are the potential side effects?

While specific side effects are not listed, common ones from similar treatments include immune reactions, injection site discomfort, flu-like symptoms, fatigue, and potential hormonal changes due to elacestrant.

Eligibility Criteria

Inclusion Criteria

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

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I've been treated with hormone therapy and a CDK 4/6 inhibitor for my advanced cancer.

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My blood counts and liver/kidney functions are within the required ranges.

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I am not pregnant.

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I agree to use birth control during the study because I can still have children.

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I am 18 years old or older.

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I am able to get out of my bed or chair and move around.

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I can read and speak English or Spanish.

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My breast cancer is hormone positive, HER2 negative, and confirmed by a biopsy.

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My cancer has an ESR1 mutation.

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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 Elacestrant before.

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My cancer has spread to my brain or spinal cord and is getting worse.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I am not pregnant or breastfeeding.

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My advanced cancer has spread and is causing severe symptoms or life-threatening complications.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Occurrence Rate

Occurrence of Treatment Related Adverse Events

Rate of Successful Completion

Secondary study objectives

Clinical Benefit Rate (CBR)

Overall Response Rate (ORR)

Progression Free Survival (PFS)

Other study objectives

Dose Limiting Toxicity

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 + DC1Experimental Treatment2 Interventions

Patients will undergo apheresis of peripheral blood to collect and create DC1 vaccines. DC1 will be pulsed with ESR1 native or mutated peptides. After DC1 vaccines have undergone safety testing and are ready to be used, patients will be injected in groin nodes (or accessible breast tumor if available) weekly with these pulsed DC1 for eight consecutive weeks. They will alternate between native ESR1 DC1s and mutated ESR1 DC1s. Patients will receive combination of DC1 vaccinations and Elacestrant concurrently. Elacestrant is a novel oral selective estrogen downregulator, administered during vaccination and continued after. Elacestrant is considered standard of care for patients with ESR1 mutated HR+ HER2-metastatic breast cancer. Pulsed DC1 will be administered after initial induction every four weeks x 3 doses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Elacestrant

2019

Completed Phase 3

~560

0 / 14Eligibility criteria met