Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer (TARMAC)

February 13, 2026 updated by: University of Chicago

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

85

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Nigeria
    • Lagos
      • Ikeja, Lagos, Nigeria, 100271
        • Recruiting
        • Lagos State University Teaching Hospital
        • Contact:
          • ABIODUN POPOOLA
          • Phone Number: +234 803 3021434
        • Contact:
          • ADEMOLA OYEKAN
          • Phone Number: +234 803 9277218
        • Principal Investigator:
          • ABIODUN POPOOLA
      • Yaba, Lagos, Nigeria, 100254
        • Recruiting
        • Lagos University Teaching Hospital
        • Contact:
          • ANTHONIA SOWUNMI
          • Phone Number: +234 803 7216723
        • Contact:
          • ADEWUNMI ALABI
          • Phone Number: +234 805 284 3206
        • Principal Investigator:
          • ANTHONIA SOWUNMI
    • Osun State
      • Ile-Ife, Osun State, Nigeria, 220005
    • Oyo State
      • Ibadan, Oyo State, Nigeria, 200285
        • Recruiting
        • University of Ibadan Hospital
        • Contact:
          • ATARA NTEKIM
          • Phone Number: +234-805 207 6619
        • Contact:
          • AYORINDE FOLASIRE
          • Phone Number: +234-802-887-9622
        • Principal Investigator:
          • ATARA NTEKIM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women ages of 18 to 70 years old
  2. Women who are able and willing to read understand and sign an informed consent document
  3. Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
  4. Patients with histologically confirmed carcinoma of the female breast with triple-negative status by immunohistochemistry (IHC). Patients who are low estrogen reception (ER) expression (< 20%), progesterone receptor (PR) negative and human epidermal growth factor 2 (HER2) negative are eligible.
  5. Clinical stages IIA -IIIC (AJCC 2009)
  6. Chemotherapy-naïve patients (for this cancer)
  7. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status 0-1

  8. Non-pregnant and not nursing.

    • Granulocyte greater than or equal to 1,500/microliter
    • Platelet count greater than or equal to 100,000/microliter
    • Absolute neutrophil count (ANC) greater than or equal to l500/microliter
    • Hemoglobin greater than or equal to 10g/deciliter
    • Bilirubin less than or equal 1.5 x upper limit of normal
    • aspartate aminotransferase (ALT or SGOT) and alanine transaminase (AST or SGPT) less than 2.5 x upper limit of normal

7. Creatinine within institutional normal limits or glomerular filtration rate greater than or equal to 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation 10. Baseline left ventricular ejection fraction of greater than or equal to 55%

Exclusion Criteria:

  1. Pregnant or lactating women.
  2. Patients with distant metastasis (brain and/or visceral metastasis)
  3. Serious, uncontrolled, concurrent infection(s).
  4. Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
  5. Participation in any investigational drug study within 4 weeks preceding the start of study treatment
  6. Other serious uncontrolled medical conditions that the treating investigator feels might compromise study participation including but not limited to chronic or active infection, HIV-positive patient, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
Participants will receive epirubicin and cyclophosphamide every three weeks for a total of 12 weeks followed by 3-weekly docetaxel for 12 weeks and carboplatin every three weeks for a total of 12 weeks. All premenopausal participants will receive luteinizing hormone-releasing hormone (LHRH) agonist goserelin (Zoladex) for contraception and fertility preservation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Breast)
Time Frame: 4 - 6 months from start of chemotherapy
How well does the study chemotherapy regimen of epirubicin and cyclophosphamide (EC) followed by docetaxel and carboplatin work to remove tumor cells in the breast. This will be determined by percentage of participants that do not have noticeable cancer cells in the breast after completing the chemotherapy regimen.
4 - 6 months from start of chemotherapy
Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Lymph Nodes)
Time Frame: 4 - 6 months from start of chemotherapy
How well does the study chemotherapy regimen of epirubicin and cyclophosphamide (EC) followed by docetaxel and carboplatin work to remove tumor cells in the lymph nodes. This will be determined by percentage of participants that do not have noticeable cancer cells in the lymph nodes after completing the chemotherapy regimen.
4 - 6 months from start of chemotherapy
Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (By Stage)
Time Frame: 4 - 6 months from start of chemotherapy
How well does the study chemotherapy regimen of epirubicin and cyclophosphamide (EC) followed by docetaxel and carboplatin work to remove tumor cells based on stage of breast cancer. This will be determined by percentage of participants that do not have noticeable cancer cells in the lymph nodes after completing the chemotherapy regimen.
4 - 6 months from start of chemotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side Effects of the Study Pre-surgery Chemotherapy Regimen
Time Frame: After 8 cycles of treatment (24 weeks)
Percentage of participants experiencing Grades 3 and 4 blood, gastrointestinal, neurological and cardiovascular toxicities.
After 8 cycles of treatment (24 weeks)
Clinical Response
Time Frame: 4 - 6 months from start of chemotherapy
Percentage of participants achieving clinical response (CR and PR) during neoadjuvant period by breast ultrasound
4 - 6 months from start of chemotherapy
Progressive Disease
Time Frame: After 8 cycles of treatment (24 weeks)
Percentage of participants with progressive disease during pre-surgery treatment period
After 8 cycles of treatment (24 weeks)
Invasive Disease Free Survival (iDFS)
Time Frame: 10 years from start of treatment
Time to cancer returning or death
10 years from start of treatment
Duration of Response
Time Frame: 10 years from start of treatment
Time to cancer worsening or death
10 years from start of treatment
Heart Related Side Effects of the Pre-Surgery Chemotherapy Regimen
Time Frame: 10 years from start of treatment
Percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) and a decrease in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50%.
10 years from start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Study Chair: Olufunmilayo Olopade, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2025

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2032

Study Registration Dates

First Submitted

February 19, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB23-0678

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Triple Negative Breast Cancer

Clinical Trials on Cyclophosphamide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe