Actively Recruiting
RAGE Inhibition to Decrease Cardiotoxicity in Women With Early Breast Cancer
Led by Georgetown University · Updated on 2025-12-24
48
Participants Needed
3
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
RAGE Inhibition to Decrease Cardiotoxicity in Women With Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with clinical or pathologic stage I-III breast cancer of any ER, PR, or HER2 status planned for chemotherapy in adjuvant or neoadjuvant setting
- Planned chemotherapy regimens include ddAC/ddT for 8 cycles, TC for 4-6 cycles, TCHP for 6 cycles, or other ddAC-including regimens per USPI Label
- No prior chemotherapy, radiotherapy, or systemic therapy for early stage breast cancer or any other malignancy
- Age 18 years or older
- ECOG performance status 0 to 2 (Karnofsky 60% or higher)
- Normal organ and bone marrow function as defined by leukocytes ≥3,000/mcL, absolute neutrophil count ≥1,500/mcL, platelets ≥100,000/mcL, total bilirubin ≤2.0 × ULN, AST/ALT ≤1.5 × ULN, and GFR ≥60 mL/min/1.73 m² if creatinine above normal
- HIV-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible
- If chronic hepatitis B infection, viral load must be undetectable on suppressive therapy
- If history of hepatitis C infection, must be treated with undetectable viral load
- No pre-existing neurodegenerative disease or impairment, including cerebrovascular accident or head injury
- No psychiatric disorders interfering with ability to consent; some allowed disorders include anxiety, depression, OCD, ADHD
- Women of child-bearing potential and men must agree to use effective contraception during and after study participation
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior chemotherapy, radiotherapy, systemic therapy, or hormonal therapy for breast cancer
- Stage IV breast cancer
- Receiving any other investigational agents
- History of allergic reactions to azeliragon or assigned chemotherapy drugs including docetaxel, cyclophosphamide, carboplatin, doxorubicin, paclitaxel, trastuzumab, pertuzumab, pembrolizumab
- Current use of strong CYP2C8 inhibitors without stopping at least 5 days before study drug
- Uncontrolled illness including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, neurodegenerative disease, or psychiatric/social issues limiting compliance
- Pregnant or breastfeeding women
- History of cancer within last 5 years except treated cervical carcinoma-in-situ or basal/squamous cell skin cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
2
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
3
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
Research Team
L
Lana Kheir
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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