Study on Reducing Heart Damage in Women with Early Breast Cancer Using RAGE Inhibitor

Sponsor: Georgetown University

Sponsor score: 40
Inactive

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

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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