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Pilot Study: Elacestrant and Dendritic Cell Vaccines for Metastatic Breast Cancer

This pilot study is testing a combination of treatments for metastatic breast cancer that is hormone receptor-positive and HER2-negative. You would receive elacestrant, a daily oral medication, along with a type of immunotherapy called Dendritic Cell (DC1) vaccines. These vaccines are given as injections in your groin or a breast tumor weekly for eight weeks. The study aims to see if this combination is safe and practical for patients. To join, you must have this specific type of breast cancer confirmed by a biopsy. The study will enroll 18 participants and is currently unclear if it's recruiting.

Study design
This is a pilot study, meaning it's a small, early-stage study to test feasibility and safety. It plans to enroll 18 participants.
What's involved
You would take elacestrant daily and receive weekly DC1 vaccine injections for eight weeks. Treatment continues until your cancer progresses.
Compensation
Not stated in the trial record.
Follow-up
The study will track your progress and any side effects for up to two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06691035

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~18 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:ElacestrantDC1 native/mutated ESR1

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Successful Completion
Measured over Up to 2 years
+2 more outcomes measured

Conditions

Breast Cancer Metastatic Breast Cancer
HER2-negative Breast Cancer

Explore related trials

Breast CarcinomaESR1 Gene

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Aixa Soyano Muller, MD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants must have histologically or cytologically confirmed diagnosis of hormone positive HER2 negative metastatic breast cancer per ASCO/CAP criteria, with diagnosis established through either a breast/axillary biopsy or biopsy of a metastatic lesion.
Participants must have Presence of an ESR1 mutation detected via tissue based or blood based (ctDNA) genomic profiling.
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 measurable or nonmeasurable (evaluable) disease on imaging by RECIST v1.1.
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
Participants must be adults 18 years or older.
Participants must have the ability to understand and the willingness to sign a written informed consent document.
Participants must be able to read and speak standard English or Spanish.
Participants must have adequate organ and marrow function as defined below:
Participants must have a negative pregnancy test for pre-menopausal women of childbearing potential.
Participants that are pre-menopausal women of childbearing potential who are sexually active with a male partner must agree to use adequate contraception prior to the study, for the duration of study participation.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Participants must have the ability to understand and the willingness to sign a written informed consent document or have a legally authorized representative sign on the participant's behalf.
Participants with treated and stable brain metastases are eligible if brain imaging shows no evidence of progression within 2 months of trial enrollment.

Exclusion

Pregnant women are excluded from this study because study treatment agent(s) used in this study may have the potential for teratogenic or abortifacient effects. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with agents used in this study, breastfeeding should be discontinued if the mother is treated with study agents used in this study.
Previous treatment with Elacestrant.
History of allergic reactions attributed to the study drugs.
Active, progressing or newly diagnosed CNS metastases, including leptomeningeal carcinomatosis, because systemic treatment would need to be paused for these patients.
Treatment with any investigational compound within 21 days prior to the first dose of study drugs or during this study.
14 day washout periods from previous anticancer therapy(ies) is required prior to enrollment including:
Cytotoxic chemotherapy
Tamoxifen or aromatase inhibitors
Fulvestrant
Targeted agents such as CDK 4/6 inhibitors, PIK3CA inhibitors, MTOR inhibitors
Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Uncontrolled intercurrent illness including-but not limited to-ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Patients with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis.
Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen \[HbsAg\]), or hepatitis C (HCV). Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody \[anti-HBc\] and absence of HbsAg) are eligible. Participants with positive Hepatitis C Virus (HCV) antibody are eligible if polymerase chain reaction is negative for HCV RNA.
Concurrent or prior use of immunosuppressive medication within 14 days before the first dose of study drugs, with the following exceptions: premedication with dexamethasone, intranasal, inhaled, topical or local steroid injections, systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or its equivalent; steroids as premedication for hypersensitivity reactions (e.g., premedication for iodinated contrast allergy before CT scan).
Inability to comply with protocol requirements.

What this trial measures

  • Rate of Successful CompletionUp to 2 years

    Feasibility: Defined as a patient's ability and willingness to complete the treatment regimen (8 weeks) to End of Treatment (EOT) (window of + 30 days from date of last study treatment). Data collection will include rate of successful completion.

  • Occurrence RateUp to 2 years

    Feasibility: Defined as a patient's ability and willingness to complete the treatment regimen (8 weeks) to End of Treatment (EOT) (window of + 30 days from date of last study treatment). Data collection will include occurrence rate for each reason stated for non-completion.

  • Occurrence of Treatment Related Adverse EventsUp to 2 years

    Number of participants with treatment related adverse events, per event category.