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MicroRNA Profiles in Triple Negative Breast Cancer
Sponsor: University College Hospital, Ibadan
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
Official title: Treatment Response and microRNA Profiles in Triple Negative Breast Cancer Patients Receiving Standard Chemotherapy
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2021-11-29
Completion Date
2030-08
Last Updated
2026-05-07
Healthy Volunteers
No
Conditions
Interventions
Epirubicin
Epirubicin is an antitumor antibiotics with good activity on breast cancer. It has less cardiotoxic effect than doxorubicin
Cyclophosphamide
Cyclophosphamide is a cytoxic drug indicated for the treatment of many malignancies including breast cancer
Paclitaxel
Paclitaxel is a taxane chemotherapy agent indicated for the treatment of many cancers including breast cancer. It can be used alone or in combination with other drugs
Carboplatin
Carboplatin is a platinum compound indicated for the treatment of many types of malignancies including breast cancer
Locations (4)
Obafemi Awolowo University Teaching Hospital
Ile-Ife, Oshun, Nigeria
University College Hospital
Ibadan, Oyo State, Nigeria
Lagos State University Teaching Hospital
Lagos, Nigeria
Lagos University Teaching Hospital
Lagos, Nigeria