OncoMatch/Clinical Trials/NCT06691035

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

Is NCT06691035 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including DC1 native/mutated ESR1 and Elacestrant for breast cancer metastatic breast cancer.

Phase 1RecruitingH. Lee Moffitt Cancer Center and Research InstituteNCT06691035Data as of May 2026

Treatment: Elacestrant · DC1 native/mutated ESR1 — 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.

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Extracted eligibility criteria

Cancer type

Breast Carcinoma

Biomarker criteria

Required: ESR1 mutation

Presence of an ESR1 mutation detected via tissue based or blood based (ctDNA) genomic profiling

Required: ESR1 expression ≥1% on immunohistochemistry (IHC) (≥1% on IHC)

Estrogen Receptor (ER) or Progesterone Receptor (PR) are considered positive when expressed ≥1% on immunohistochemistry (IHC)

Required: PR (PGR) expression ≥1% on immunohistochemistry (IHC) (≥1% on IHC)

Estrogen Receptor (ER) or Progesterone Receptor (PR) are considered positive when expressed ≥1% on immunohistochemistry (IHC)

Required: HER2 (ERBB2) negative by IHC (0 or 1+), or 2+ with ISH not amplified (IHC 0 or 1+, or 2+ with ISH not amplified)

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

Disease stage

Metastatic disease required

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: endocrine therapy — metastatic

previously treated with at least 1 line of endocrine therapy

Must have received: CDK4/6 inhibitor — metastatic

previously treated with...a CDK 4/6 inhibitor in the metastatic setting

Cannot have received: (Elacestrant)

Previous treatment with Elacestrant

Lab requirements

Blood counts

absolute neutrophil count ≥1,000/mcL; platelets ≥75,000/mcL; hemoglobin (Hb) ≥ 9 g/dL

Kidney function

creatinine 1.5 ≤ institutional ULN

Liver function

AST(SGOT)/ALT(SGPT) ≤3 fold × institutional ULN; Total bilirubin < 1.5 x ULN or <3 x ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia)

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)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

Moffitt Cancer Center · Tampa, Florida

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