RecruitingPhase 1Phase 2NCT05256745

RAGE Inhibition to Decrease Cardiotoxicity in Women With Early Breast Cancer

RAGE Inhibition to Decrease Cancer Therapy Related Cardio Toxicity in Women With Early Breast Cancer


Sponsor

Georgetown University

Enrollment

48 participants

Start Date

Jun 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a pilot study to evaluate the effects of azeliragon to decrease cardiac toxicity from chemotherapy and the safety of azelirgaon when given with chemotherapy. The Investigators hypothesize that there will be no significant interaction with Azeliragon and chemotherapy and that targeting the RAGE pathway will decrease anthracycline related cardiotoxicity and chemotherapy related cognitive decline.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug that blocks a protein called RAGE can protect the heart from the damaging effects of chemotherapy in women with early-stage breast cancer. Chemotherapy drugs like doxorubicin can cause long-term heart damage, and this trial aims to find a way to prevent that. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with stage I-III breast cancer (any receptor status) - You are scheduled to receive one of several qualifying chemotherapy regimens that include doxorubicin (AC-based) or other standard combinations - You have not received prior chemotherapy, radiation, or systemic therapy for this cancer - Your blood counts and organ function are within acceptable ranges - You are in reasonably good health (ECOG performance status 0-2) **You may NOT be eligible if...** - You have already received chemotherapy or radiation for breast cancer or any prior cancer - You have significant pre-existing heart disease - You are pregnant or breastfeeding - You have severe kidney or liver problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTTP488

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

DRUGddAC/ddT

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

DRUGTC

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

DRUGTCHP

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

DRUGChemotherapy 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


Locations(3)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, United States

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

John Theurer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

View Full Details on ClinicalTrials.gov

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NCT05256745


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