Study of Standard Chemotherapy Response and microRNA Levels in Women with Triple Negative Breast Cancer

What this Trial Is About

Researchers are studying triple negative breast cancer TNBC, an aggressive type of breast cancer that affects more Black women and younger age groups. This cancer lacks targeted treatments, so chemotherapy remains the main systemic therapy, though resistance often develops quickly. The study aims to evaluate the response rate to a standard chemotherapy regimen and explore if blood levels of microRNA and circulating tumor DNA can indicate treatment failure early in Nigerian women with TNBC. Participants will receive a sequence of chemotherapy drugs Epirubicin and Cyclophosphamide every three weeks for four cycles, followed by Paclitaxel and Carboplatin every three weeks for four cycles. Blood samples will be collected before, during, and after treatment to measure microRNA and tumor DNA levels. Tumor response will be assessed by ultrasound using RECIST criteria, and treatment side effects will be graded using CTCAE guidelines. Quality of life will be monitored with the EORTC questionnaire. During the study, patients will undergo clinical evaluations, imaging, blood tests, and quality of life assessments. The main outcomes include the proportion of patients achieving complete response after chemotherapy and the incidence of treatment-related side effects, monitored up to five years. Secondary measures include disease-free survival at 2, 5, and 10 years, and changes in quality of life. Total participation may last up to 10 years for long-term monitoring of outcomes and side effects.

MicroRNA Profiles in Triple Negative Breast Cancer