MicroRNA Profiles in Triple Negative Breast Cancer
Status:
Not yet recruiting
Trial end date:
2023-08-01
Target enrollment:
Participant gender:
Summary
Triple negative breast cancer (TNBC) is an aggressive disease with higher proportion of
Blacks affected and in younger age groups. There is no targeted therapy unlike other types of
breast cancer such as hormone positive and Human Epidermal Growth factor 2 (HER2) positive
subtypes. Chemotherapy is therefore the main choice of systemic treatment with rapid
development of resistance in most cases. At present, there is no blood test to monitor
treatment response and disease relapse. This one-stage phase II study with a single arm
design will determine the response rate of standard chemotherapy using Epirubicin (60mg/m2),
Cyclophosphamide (600mg/m2) , Paclitaxel (120mg/m2) and Carboplatin (6AUC) in TNBC patients.
We will measure the blood level of microRNA molecules and circulating tumor DNA during and
after treatment to test if changes can be used to indicate drug failure in these patients.
Disease status and tumor response will be assessed using Response Evaluation Criteria in
Solid Tumors (RECIST) guidelines while toxicity will be assessed using CTCAE v5). The trial
will be conducted as per the International Council on Harmonisation Good Clinical Practice
(ICH GCP) Guidelines E6 (R1) and other applicable guidelines
Phase:
Phase 2
Details
Lead Sponsor:
University College Hospital, Ibadan
Collaborators:
Lagos State University Obafemi Awolowo University Teaching Hospital University of Chicago University of Ibadan University of Lagos, Nigeria