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RECRUITING
NCT04771871
PHASE2

MicroRNA Profiles in Triple Negative Breast Cancer

Sponsor: University College Hospital, Ibadan

View on ClinicalTrials.gov

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

Interventions

DRUG

Epirubicin

Epirubicin is an antitumor antibiotics with good activity on breast cancer. It has less cardiotoxic effect than doxorubicin

DRUG

Cyclophosphamide

Cyclophosphamide is a cytoxic drug indicated for the treatment of many malignancies including breast cancer

DRUG

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

DRUG

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