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

PHASE1RecruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

November 4, 2024

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2027

Conditions
Breast Cancer Metastatic Breast CancerHER2-negative Breast Cancer
Interventions
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."

Trial Locations (1)

33612

RECRUITING

Moffitt Cancer Center, Tampa

All Listed Sponsors
collaborator

The V Foundation for Cancer Research

OTHER

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER