OncoMatch/Clinical Trials/NCT06691035
Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer
Is NCT06691035 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including DC1 native/mutated ESR1 and Elacestrant for breast cancer metastatic breast cancer.
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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Other
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
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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06691035 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 mutation is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 expression ≥1% on immunohistochemistry (IHC) is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression ≥1% on immunohistochemistry (IHC) is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify