MicroRNA Profiles in Triple Negative Breast Cancer

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

Conditions

• Triple Negative Breast Cancer

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

Sponsors & Collaborators

• Lagos State University

  collaborator OTHER

• Obafemi Awolowo University Teaching Hospital

  collaborator OTHER

• University of Chicago

  collaborator OTHER

• University of Lagos, Nigeria

  collaborator OTHER

• University of Ibadan

  collaborator OTHER

• University College Hospital, Ibadan

  lead OTHER

Principal Investigators

• Olufunmilayo I. Olopade · University of Chicago

• Atara Ntekim · University of Ibadan

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-29

Primary Completion

2027-03-31

Completion

2030-08-31

Countries

• Nigeria

Study Locations