RecruitingPhase 1NCT06691035

Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer

Immunologic Targeting of Native and Mutated ESR1 Receptor for Treatment of Hormone Receptor Expressing Metastatic Breast Cancer


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

18 participants

Start Date

Nov 4, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a pilot study to determine feasibility and safety of the combination of Dendritic Cell (DC1) vaccines and elacestrant in patients with hormone positive HER2 negative metastatic breast cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a vaccine-based immunotherapy that targets the estrogen receptor (ESR1) — a protein that fuels the growth of many hormone receptor-positive breast cancers — in women with metastatic hormone receptor-positive, HER2-negative breast cancer. The goal is to train the immune system to attack cancer cells that rely on this receptor. **You may be eligible if...** - You have been diagnosed with metastatic (spread) hormone receptor-positive, HER2-negative breast cancer confirmed by biopsy - Your cancer expresses estrogen receptor or progesterone receptor (at least 1% on testing) - You have received prior standard treatments including CDK4/6 inhibitors and at least one hormonal therapy **You may NOT be eligible if...** - Your cancer is HER2-positive - You have not received prior standard hormone therapy - You have active autoimmune disease or are on immunosuppressant medications - You have untreated brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGElacestrant

345 mg (or 86 mg tablets) orally daily during vaccination and continued after until progression. Cycle Length 28 days (4 weeks)

BIOLOGICALDC1 native/mutated ESR1

2.0-5.0 x 10 (20-50 million) cells (Injections in groin nodes (or accessible breast tumor if available) weekly with DC1 for eight consecutive weeks, alternating between native ESR1 DC1s and mutated ESR1 DC1s. Mutated ESR1 DC1s on week 1 followed by native ESR1 DC1s on week 2, alternating during the initial vaccination series and the subsequent booster phase. Pulsed DC1 will be administered after initial induction every four weeks x 3 doses.


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT06691035


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