Triple Negative Breast CancerPhase 2TARMACNCT06291064
Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer
A Phase 2 study testing Cyclophosphamide, Epirubicin and Docetaxel in people with Triple Negative Breast Cancer, run by University of Chicago at 4 sites in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Cyclophosphamide, Epirubicin and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 4 sitesNigeria
- Study dates
- 18 Mar 2025to Jun 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 15Show fewer
- 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
- 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%
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nigeria4 sites, 4 recruiting
- Recruiting
University of Ibadan Hospital
Ibadan, Oyo State, 200285
ATARA NTEKIM, +234-805 207 6619
AYORINDE FOLASIRE, +234-802-887-9622
- Recruiting
Lagos State University Teaching Hospital
Ikeja, Lagos, 100271
ABIODUN POPOOLA, +234 803 3021434
ADEMOLA OYEKAN, +234 803 9277218
- Recruiting
Obafemi Awolowo University Teaching Hospitals Complex
Ile-Ife, Osun State, 220005
Olalekan Olasehinde, 2348060716670, lekanolasehinde@yahoo.com
Ifeoluwa Olagunju, 2347053670305, ifeoluwaolagunju4@gmail.com
- Recruiting
Lagos University Teaching Hospital
Yaba, Lagos, 100254
ANTHONIA SOWUNMI, +234 803 7216723
ADEWUNMI ALABI, +234 805 284 3206
About this study
Official title: 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.
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Cyclophosphamide, Epirubicin, Docetaxel, Carboplatin, Breast Surgery
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Cyclophosphamide is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Epirubicin.
EpirubicinDrug
Epirubicin is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Cyclophosphamide.
DocetaxelDrug
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.
CarboplatinDrug
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 SurgeryProcedure or surgery
Participants will undergo breast surgery after completing dosing with Carboplatin and Docetaxel to remove any remaining cancer in the breast.
CapecitabineDrug
Capecitabine is a pill that will be taken by mouth daily for 6 months after surgery is completed.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | 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. Receives: Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Docetaxel; Drug: Carboplatin; Procedure: Breast Surgery; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Breast)
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.
Measured: 4 - 6 months from start of chemotherapy
Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Lymph Nodes)
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.
Measured: 4 - 6 months from start of chemotherapy
Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (By Stage)
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.
Measured: 4 - 6 months from start of chemotherapy
Secondary outcomes (6)
Side Effects of the Study Pre-surgery Chemotherapy Regimen
Percentage of participants experiencing Grades 3 and 4 blood, gastrointestinal, neurological and cardiovascular toxicities.
Measured: After 8 cycles of treatment (24 weeks)
Clinical Response
Percentage of participants achieving clinical response (CR and PR) during neoadjuvant period by breast ultrasound
Measured: 4 - 6 months from start of chemotherapy
Progressive Disease
Percentage of participants with progressive disease during pre-surgery treatment period
Measured: After 8 cycles of treatment (24 weeks)
Invasive Disease Free Survival (iDFS)
Time to cancer returning or death
Measured: 10 years from start of treatment
Duration of Response
Time to cancer worsening or death
Measured: 10 years from start of treatment
Heart Related Side Effects of the Pre-Surgery Chemotherapy Regimen
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%.
Measured: 10 years from start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start18 Mar 2025
- Primary completionJun 2029 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olufunmilayo Olopade, MD, Study chair, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291064
- Sponsor's protocol ID
- IRB23-0678
- Acronym
- TARMAC
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TreAtment Response and Omic-Markers in Triple-Negative Breast CAncer Patients Receiving Standard of Care Chemotherapy (TARMAC)
- ClinicalTrials.gov ID
- NCT06291064
- Acronym / sponsor ID
- TARMAC / IRB23-0678
- Conditions
- Triple Negative Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Cyclophosphamide, Drug: Epirubicin, Drug: Docetaxel, Drug: Carboplatin, Procedure: Breast Surgery, Drug: CapecitabineParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideCyclophosphamide is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Epirubicin. | Drug | Treatment Arm |
| EpirubicinEpirubicin is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Cyclophosphamide. | Drug | Treatment Arm |
| DocetaxelDocetaxel 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 | Treatment Arm |
| CarboplatinCarboplatin 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. | Drug | Treatment Arm |
| Breast SurgeryParticipants will undergo breast surgery after completing dosing with Carboplatin and Docetaxel to remove any remaining cancer in the breast. | Procedure or surgery | Treatment Arm |
| CapecitabineCapecitabine is a pill that will be taken by mouth daily for 6 months after surgery is completed. | Drug | Treatment Arm |
Primary outcome
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.
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.
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.
6 secondary outcomes
Side Effects of the Study Pre-surgery Chemotherapy Regimen
Time frame: After 8 cycles of treatment (24 weeks)
Clinical Response
Time frame: 4 - 6 months from start of chemotherapy
Progressive Disease
Time frame: After 8 cycles of treatment (24 weeks)
Invasive Disease Free Survival (iDFS)
Time frame: 10 years from start of treatment
Duration of Response
Time frame: 10 years from start of treatment
Heart Related Side Effects of the Pre-Surgery Chemotherapy Regimen
Time frame: 10 years from start of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olufunmilayo Olopade, MD study chair
University of Chicago
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide, Epirubicin and Docetaxel in people with Triple Negative Breast Cancer, run by University of Chicago at 4 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilona Siljander (773-834-6542, isiljander1@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants that Achieve Pathologic Complete Response (pCR) Rate (Breast) (time frame: 4 - 6 months from start of chemotherapy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.