Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

PHASE1RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

September 25, 2023

Primary Completion Date

February 23, 2027

Study Completion Date

February 23, 2027

Conditions
Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8Metastatic Triple-Negative Breast CarcinomaUnresectable Triple-Negative Breast Carcinoma
Interventions
PROCEDURE

Biopsy Procedure

Undergo biopsy

PROCEDURE

Biospecimen Collection

Undergo collection of blood

PROCEDURE

Computed Tomography

Undergo CT

DRUG

Decitabine and Cedazuridine

Given PO

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

DRUG

Paclitaxel

Given IV

BIOLOGICAL

Pembrolizumab

Given IV

Trial Locations (10)

15232

RECRUITING

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh

23298

RECRUITING

VCU Massey Comprehensive Cancer Center, Richmond

43210

RECRUITING

Ohio State University Comprehensive Cancer Center, Columbus

55905

RECRUITING

Mayo Clinic in Rochester, Rochester

73104

RECRUITING

University of Oklahoma Health Sciences Center, Oklahoma City

85054

RECRUITING

Mayo Clinic Hospital in Arizona, Phoenix

92627

RECRUITING

UC Irvine Health Cancer Center-Newport, Costa Mesa

92868

RECRUITING

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange

95817

ACTIVE_NOT_RECRUITING

University of California Davis Comprehensive Cancer Center, Sacramento

32224-9980

RECRUITING

Mayo Clinic in Florida, Jacksonville

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH