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Active Not Recruiting
NCT06691035
Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer
Conditions: Breast Cancer Metastatic Breast Cancer, HER2-negative Breast Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 18
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Location: Moffitt Cancer Center Tampa Florida
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 Criteria
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 \
Source: ClinicalTrials.gov (NCT06691035). StuddyBuddy aggregates publicly available trial information.