NCT06291064

Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Triple Negative Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-18
• Primary completion: 2029-06-01
• Completion: 2032-06-01
• First posted: 2024-03-04
• Last updated: 2026-02-17

Locations

4 sites across 1 country: Nigeria

Regulatory

• FDA-regulated drug study