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RECRUITING
NCT06291064
PHASE2

Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer

Sponsor: University of Chicago

View on ClinicalTrials.gov

Summary

The primary purpose of this study is to determine what proportion of participants will achieve complete pathological response with epirubicin+ cyclophosphamide followed by docetaxel +carboplatin. This will also examine the potential of using signals in the blood (biomarkers) to identify resistance to chemotherapy in Nigerian women with triple negative breast cancer (TNBC). All enrollment to this trial will occur at sites in Nigeria. University of Chicago is serving as coordinating center and will be involved in data analysis.

Official title: TreAtment Response and Omic-Markers in Triple-Negative Breast CAncer Patients Receiving Standard of Care Chemotherapy (TARMAC)

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

85

Start Date

2025-03-18

Completion Date

2032-06

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

DRUG

Cyclophosphamide

Cyclophosphamide is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Epirubicin.

DRUG

Epirubicin

Epirubicin is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Cyclophosphamide.

DRUG

Docetaxel

Docetaxel is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Carboplatin. Dosing will start after treatment with Epirubicin and Cyclophosphamide (EC) is completed.

DRUG

Carboplatin

Carboplatin is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Docetaxel. Dosing will start after treatment with EC is completed.

PROCEDURE

Breast Surgery

Participants will undergo breast surgery after completing dosing with Carboplatin and Docetaxel to remove any remaining cancer in the breast.

DRUG

Capecitabine

Capecitabine is a pill that will be taken by mouth daily for 6 months after surgery is completed.

Locations (4)

Lagos State University Teaching Hospital

Ikeja, Lagos, Nigeria

Lagos University Teaching Hospital

Yaba, Lagos, Nigeria

Obafemi Awolowo University Teaching Hospitals Complex

Ile-Ife, Osun State, Nigeria

University of Ibadan Hospital

Ibadan, Oyo State, Nigeria