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NCT Number: NCT06291064

Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer

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.

Recruiting

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Key information

Conditions

Triple Negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Lagos State University Teaching Hospital, Ikeja, Lagos, Nigeria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women ages of 18 to 70 years old
  • Women who are able and willing to read understand and sign an informed consent document
  • Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
  • 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.
  • Clinical stages IIA -IIIC (AJCC 2009)
  • Chemotherapy-naïve patients (for this cancer)
  • Performance status: Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • 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
  • 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

  • Pregnant or lactating women.
  • Patients with distant metastasis (brain and/or visceral metastasis)
  • Serious, uncontrolled, concurrent infection(s).
  • Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
  • Participation in any investigational drug study within 4 weeks preceding the start of study treatment
  • 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.

Treatment and study plan

Cyclophosphamide

Drug

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

Epirubicin

Drug

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

docetaxel

Drug

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.

carboplatin

Drug

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.

Breast surgery

Procedure

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

Capecitabine

Drug

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

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. Progressive Disease

    Time frame: After 8 cycles of treatment (24 weeks)

    Percentage of participants with progressive disease during pre-surgery treatment period

  4. Invasive Disease Free Survival (iDFS)

    Time frame: 10 years from start of treatment

    Time to cancer returning or death

  5. Duration of Response

    Time frame: 10 years from start of treatment

    Time to cancer worsening or death

  6. 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%.

Study contacts

Contact information is provided by the study sponsor or research team.

Ilona Siljander

CONTACT

[email protected]

773-834-6542

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Acronym: TARMAC

Important dates

Study start
2025
Primary completion
2029
Study completion
2032
First posted
Mar 4, 2024
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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