RAGE Inhibition to Decrease Cardiotoxicity in Women With Early Breast Cancer

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

June 6, 2023

Primary Completion Date

October 31, 2025

Study Completion Date

October 31, 2025

Conditions
Cancer Related Cognitive DeclineNon-metastatic Breast Cancer
Interventions
DRUG

TTP488

Each Azeliragon capsule is 5mg, and is to be taken in the morning with food as indicated in each cohort.

DRUG

ddAC/ddT

Dose dense doxorubicin plus cyclophosphamide followed by paclitaxel (ddAC/ddT) for 8 cycles, administered per USPI (Unites States Prescribing Information) Label

DRUG

TC

Docetaxel plus cyclophosphamide (TC) for 4-6 cycles, administered per USPI (Unites States Prescribing Information) Label

DRUG

TCHP

Docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP)for 6 cycles, administered per USPI (Unites States Prescribing Information) Label

DRUG

Chemotherapy regimen that includes ddAC

can include: (1) weekly carboplatin + paclitaxel + pembrolizumab followed by pembrolizumab + dose dense doxorubicin and cyclophosphamide; (2) weekly carboplatin + paclitaxel followed by dose dense doxorubicin and cyclophosphamide; (3) weekly or dose dense paclitaxel followed by dose dense doxorubicin and cyclophosphamide, administered per USPI (Unites States Prescribing Information) Label

Trial Locations (3)

20007

RECRUITING

Georgetown Lombardi Comprehensive Cancer Center, Washington D.C.

20010

RECRUITING

Medstar Washington Hospital Center, Washington D.C.

07601

RECRUITING

John Theurer Cancer Center at Hackensack University Medical Center, Hackensack

All Listed Sponsors
lead

Georgetown University

OTHER