NCT07112053View on ClinicalTrials.gov

A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

October 2, 2025

Primary Completion Date

July 31, 2028

Study Completion Date

December 31, 2028

Conditions
Anatomic Stage IV Breast Cancer AJCC v8Metastatic HER2-Negative Breast CarcinomaMetastatic Hormone Receptor-Positive Breast Carcinoma
Interventions
BIOLOGICAL

CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine

Given ID

DRUG

Capecitabine

Given SOC capecitabine

PROCEDURE

Computed Tomography

Undergo CT or ultrasound-guided biopsies

DRUG

Cyclin-Dependent Kinase 4 Inhibitor

Given SOC CDK4/6i

DRUG

Cyclin-Dependent Kinase 6 Inhibitor

Given SOC CDK4/6i

DRUG

F-18 16 Alpha-Fluoroestradiol

Undergo FES PET

DRUG

Hormone Therapy

Given SOC ET

PROCEDURE

Positron Emission Tomography

Undergo FES PET

PROCEDURE

Ultrasound Imaging

Undergo CT or ultrasound-guided biopsies

PROCEDURE

Biopsy Procedure

Undergo CT or ultrasound-guided biopsies

PROCEDURE

Biospecimen Collection

Undergo collection of blood samples

Trial Locations (1)

98109

RECRUITING

Fred Hutch/University of Washington Cancer Consortium, Seattle

All Listed Sponsors
lead

University of Washington

OTHER