eligibility_summary
Include: Adults >=18 with HR+ HER2- mBC, ESR1 mutation (tissue/ctDNA), prior ET + CDK4/6 inhibitor, measurable/evaluable disease, ECOG 0-2, adequate organ function, treated stable brain mets allowed. Exclude: pregnant/breastfeeding, prior elacestrant, active/progressing CNS/LMD, recent investigational therapy, <14-d washout from chemo/ET/targeted, other malignancy <=2 y, uncontrolled illness/visceral crisis, HIV+, active TB/HBV or HCV unless RNA-, immunosuppression (except low-dose/local).
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06691035 tests elacestrant plus a DC1 dendritic‑cell vaccine in HR+/HER2– metastatic breast cancer with ESR1 mutations. Elacestrant (Oserdu) is an oral small‑molecule selective estrogen receptor downregulator/degrader (SERD) that binds ERα (ESR1), antagonizes estrogen signaling, and promotes receptor degradation, suppressing ER‑dependent growth including ESR1‑mutant tumors. The DC1 product is an autologous, type‑1–polarized dendritic‑cell vaccine pulsed with peptides from native and mutated ESR1, injected into lymph nodes or tumor to present antigen (MHC I/II) and prime Th1/CD8+ T‑cell responses. Targets: ESR1/ER signaling on tumor cells, dendritic cells and T‑cell–mediated cytotoxicity against ER‑expressing and ESR1‑mutant cancer cells. Key pathways: estrogen receptor transcriptional signaling, antigen presentation, and adaptive immune (Th1/CD8+) effector pathways.