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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer (NCT06691035) is a Phase 1 interventional studying Breast Cancer Metastatic Breast Cancer and HER2-negative Breast Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Breast Cancer Metastatic Breast Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 18 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Participants must have diagnosed by tissue sample (biopsy-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. 1. Estrogen Receptor (ER) or Progesterone Receptor (PR) are considered positive when expressed ≥1% on immunohistochemistry (IHC). 2. HER2 is considered negative by IHC when expression is 0 or 1+ and if equivocal 2+ then a reflex in situ hybridization should be not amplified (standard practice per ASCO/CAP criteria). - 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 willing to sign a consent form document. - Participants must be able to read and speak standard English or Spanish. - Participants must have adequate organ and marrow function as defined below: 1. absolute neutrophil count ≥1,000/mcL 2. platelet count at least 75,000/mcL d. AST(SGOT)/ALT(SGPT) ≤3 fold × institutional ULN e. creatinine 1.5 ≤ institutional ULN f. hemoglobin (Hb) ≥ 9 g/dL g. Total bilirubin \< 1.5 x ULN or \<3 x ULN in the presence of documented Gilbert's syndrome unconjugated hyperbilirubinemia) - Participants must have a negative pregnancy test for pre-menopausal women of childbearing potential. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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. 1. Estrogen Receptor (ER) or Progesterone Receptor (PR) are considered positive when expressed ≥1% on immunohistochemistry (IHC). 2. HER2 is considered negative by IHC when expression is 0 or 1+ and if equivocal 2+ then a reflex in situ hybridization should be not amplified (standard practice per ASCO/CAP criteria). * 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: 1. absolute neutrophil count ≥1,000/mcL 2. platelets ≥75,000/mcL d. AST(SGOT)/ALT(SGPT) ≤3 fold × institutional ULN e. creatinine 1.5 ≤ institutional ULN f. hemoglobin (Hb) ≥ 9 g/dL g. Total bilirubin \< 1.5 x ULN or \<3 x ULN in the presence of documented Gilbert's syndrome unconjugated hyperbilirubinemia) * 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. * Inclusion of minorities: patients of all races and ethnic groups who meet the above inclusion and below exclusion criteria are eligible for this trial. * 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 Criteria: * 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.

Treatments Being Tested

DRUG

Elacestrant

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

BIOLOGICAL

DC1 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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Moffitt Cancer Center
Tampa, Florida, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06691035), the sponsor (H. Lee Moffitt Cancer Center and Research Institute), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06691035 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06691035?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06691035?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06691035. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06691035. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.