Study on Reducing Heart Damage in Women with Early Breast Cancer Using RAGE Inhibitor
Sponsor: Georgetown University
ClinicalTrials ID:NCT05256745
This study is testing whether a drug called azeliragon can reduce heart damage caused by chemotherapy in women with early-stage breast cancer. Researchers also want to see if azeliragon is safe to use alongside chemotherapy.
Patient Parameters
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Program Overview
This pilot study aims to find out if azeliragon can help reduce heart damage from chemotherapy in women with early-stage breast cancer. The study will also check if azeliragon is safe to use with chemotherapy. Researchers believe that azeliragon will not interfere with chemotherapy and may help reduce heart-related side effects and cognitive decline associated with chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Women with early-stage breast cancer (Stage I-III) who are scheduled to receive chemotherapy.
- Chemotherapy plans may include specific regimens like doxorubicin with cyclophosphamide followed by paclitaxel, or other similar combinations.
- No previous chemotherapy, radiotherapy, or systemic therapy for breast cancer or any other cancer.
- Age 18 years or older.
- Good overall health with a performance status score of 2 or less.
- Normal blood and organ function based on specific medical tests.
- HIV-positive patients can participate if their viral load is undetectable and they are on effective treatment.
- No history of neurodegenerative diseases or significant head injuries.
- No psychiatric disorders that would affect the ability to consent to the study.
- Women and men must agree to use effective birth control during the study.
- Ability to understand and sign a consent form.
Exclusion Criteria
- Previous chemotherapy, radiotherapy, or systemic therapy for breast cancer.
- Stage IV breast cancer.
- Participation in other experimental drug studies.
- Allergic reactions to azeliragon or similar chemotherapy drugs.
- Use of certain medications that interact with azeliragon.
- Uncontrolled health issues like active infections, heart problems, or psychiatric conditions.
- Pregnant or breastfeeding women.
- History of other cancers in the last 5 years, except for certain skin cancers or cervical cancer treated successfully.
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