MicroRNA Profiles in Triple Negative Breast Cancer (TARMAC)

April 30, 2026 updated by: Atara Ntekim, University College Hospital, Ibadan

Treatment Response and microRNA Profiles in Triple Negative Breast Cancer Patients Receiving Standard Chemotherapy

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Triple negative subtype of breast cancer (TNBC), accounts for about 55% of all breast cancer among indigenous blacks, such as Nigerians, and younger women are more susceptible Patients with TNBC generally experience a more aggressive clinical course with faster disease progression and poorer overall survival. There is no targeted treatment available beyond conventional cytotoxic chemotherapy . Unfortunately, standard chemotherapy is only effective in about 40% of patients with pathological complete response (pCR) achieved only in 20%-30% . Local relapse occurs early. Therefore, chemo-resistance is the main cause of chemotherapeutic failure and leads to suboptimal response rates . There are no biomarkers of response for close monitoring of TNBC patients to identify chemotherapy failure early. This one-stage phase II study with a single arm is designed to assess the response rate and toxicity of Epirubicin-Cyclophosphamide with Paclitaxel-Carboplatin (ECPC) and examine the potential of using circulating microRNa and circulating tumor cells as a surrogate marker of chemotherapy resistance in Nigerian women with triple negative breast cancer. A total of 42 patients will be enrolled into the trial. Each participant will receive Epirubicin (60mg/m2), Cyclophosphamide (600mg/m2) , Paclitaxel (120mg/m2) and Carboplatin (6AUC) . Blood microRNA and circulating tumor DNA will be determined before and after therapy. Tumor response will be measured by breast ultrasound and described using RECIST criteria while toxicity will be graded using CTCAE criteria. Quality of life (QoL) of participants while on chemotherapy will also be assessed using EORTC quality of life questionnaire - (General and Breast cancer specific).

Study Type

Interventional

Enrollment (Estimated)

42

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 Contact Backup

Study Locations

  • Nigeria
      • Lagos, Nigeria
        • Not yet recruiting
        • Lagos State University Teaching Hospital
        • Contact:
        • Principal Investigator:
          • Abiodun Popoola, MD
        • Sub-Investigator:
          • Ayodele Sanni, MD
        • Sub-Investigator:
          • Abiola Ibraheem, MD
      • Lagos, Nigeria
        • Not yet recruiting
        • Lagos University Teaching Hospital
        • Contact:
        • Principal Investigator:
          • Anthonia Sowunmi, MD
        • Sub-Investigator:
          • Thomas Olajide
        • Sub-Investigator:
          • Fatima Abdulkareem
    • Oshun
      • Ile-Ife, Oshun, Nigeria
        • Not yet recruiting
        • Obafemi Awolowo University Teaching Hospital
        • Contact:
        • Principal Investigator:
          • Olukayode Arowolo, MD
        • Sub-Investigator:
          • Akinwunmi Komolafe, MD
    • Oyo State
      • Ibadan, Oyo State, Nigeria, 200221
        • Recruiting
        • University College Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Atara Ntekim, MD
        • Sub-Investigator:
          • Adenike Adeniji-Sofoluwe, MD
        • Sub-Investigator:
          • Ayorinde Folasire, MD

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women ages of 18 to 70 years old
  2. Women who give informed consent for the study
  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 immuno-histochemistry (IHC)
  5. Clinical stages IIA -IIIC (AJCC 2009)
  6. Chemotherapy-naïve patients (for this malignancy)
  7. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  8. Non-pregnant and not nursing. Women of childbearing potential must take the pregnancy test and must commit to receive Leuteinizing Hormone Realising Hormone (LHRH) agonist Zoladex (goserelin) for two years starting from the commencement of the study medications
  9. Required Initial Laboratory Data. Adequate hematologic, renal and hepatic function, as defined by each of the following:

1. Granulocyte ≥ 1,500/μL 2. Platelet count ≥ 100,000/μL 3. Absolute neutrophil count (ANC) ≥ l500/μL 4. Hemoglobin ≥ 10g/dL 5. Bilirubin ≤ 1.5 x upper limit of normal 6. SGOT and SGPT < 2.5 x upper limit of normal 7. Creatinine within institutional normal limits or glomerular filtration rate ≥ 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) (CKD EPI) equation (see http://mdrd.com/ for calculator) 10. Echocardiogram (ECHO): Baseline left ventricular ejection fraction of ≥ 55%

Exclusion Criteria:

  1. Pregnant or lactating women. Women of childbearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
  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 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: Epirubicin-Cyclophosphamide plus Paclitaxel- Carboplatin
Epirubicin 60mg/m2 with cyclophosphamide 600/m2 every three weeks for four courses followed by paclitaxel 120mg/m2 and carboplatin 6 AUC every three weeks for four courses
Drug: Epirubicin
Epirubicin is an antitumor antibiotics with good activity on breast cancer. It has less cardiotoxic effect than doxorubicin
Other Names:
  • Paraplatin
  • Taxol
  • Pharmorubicin
  • Cytoxan
Drug: Cyclophosphamide
Cyclophosphamide is a cytoxic drug indicated for the treatment of many malignancies including breast cancer
Other Names:
  • Cytoxan
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
Other Names:
  • Taxol
Drug: Carboplatin
Carboplatin is a platinum compound indicated for the treatment of many types of malignancies including breast cancer
Other Names:
  • Carboplat
  • Paraplatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants achieving pathological complete response (pCR) at surgery following neoadjuvant treatment with epirubicin + cyclophosphamide every three weeks for four cycles followed by paclitaxel + carboplatin every three weeks for four cycles
Time Frame: 4 - 6 months from commencement of chemotherapy. (Surgery will be performed within 4-6 weeks after completion of chemotherapy
Percentage of participants achieving pathological complete response (pCR) at surgery
4 - 6 months from commencement of chemotherapy. (Surgery will be performed within 4-6 weeks after completion of chemotherapy
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time Frame: From the date of commencement of chemotherapy till date of first documentation of adverse event up to 60 months or withdrawal or death from any cause or which ever occurs first.
Percentage of participants experiencing grades 3 and 4 hematological, gastro-intestinal, neurological and cardiovascular toxicities.
From the date of commencement of chemotherapy till date of first documentation of adverse event up to 60 months or withdrawal or death from any cause or which ever occurs first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants without disease for 2 , 5 and 10 years respectively
Time Frame: From date of first dose of study drug treatment up to a maximum of 120 months years.
Invasive Disease Free Survival (iDFS )
From date of first dose of study drug treatment up to a maximum of 120 months years.
Change in quality of life (QoL) score of patients from baseline using the EORTC quality of life questionnaire during chemotherapy and at study completion
Time Frame: From date of commencement of study medications up to 60 months
The various domains of QoL over time and the changes from baseline using the validated European Organization for Research and Treatment of Cancer (EORTC)) QoL instrument (global and breast module).
From date of commencement of study medications up to 60 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The serum levels of circulating microRNAs during chemotherapy in TNBC. To explore mechanisms of resistance to chemotherapy in Nigerian women with TNBC
Time Frame: From date of commencement of chemotherapy up to 24 weeks
The fold change in serum levels of miRNA during chemotherapy will be determine in TNBC patients before and during each course of chemotherapy.
From date of commencement of chemotherapy up to 24 weeks

Collaborators and Investigators

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

Sponsor

University College Hospital, Ibadan

Collaborators

University of Chicago
Lagos State University
Obafemi Awolowo University Teaching Hospital
University of Lagos, Nigeria
University of Ibadan

Investigators

  • Study Chair: Olufunmilayo I. Olopade, University of Chicago
  • Principal Investigator: Atara Ntekim, University of Ibadan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 29, 2021

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

August 1, 2030

Study Registration Dates

First Submitted

February 14, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UI-ROD-OCTU02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification. The data will be deposited with the journal as supplementary data. Access will be as per journals policy

IPD Sharing Time Frame

Immediately following publication. No end date

IPD Sharing Access Criteria

As per publishing Journal's policy

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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