Combination chemotherapy for Nigerian women with triple-negative breast cancer.
TreAtment Response and Omic-Markers in Triple-Negative Breast CAncer Patients Receiving Standard of Care Chemotherapy (TARMAC)
This will test whether epirubicin plus cyclophosphamide followed by docetaxel plus carboplatin leads to complete tumor disappearance at surgery and whether blood biomarkers can show chemotherapy resistance in Nigerian women with triple-negative breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 85 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | University of Chicago Academic / other |
| Drugs / interventions | Chemotherapy, cyclophosphamide |
| Locations | 4 sites (Ikeja, Lagos and 3 other locations) |
| Trial ID | NCT06291064 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional protocol gives epirubicin plus cyclophosphamide followed by docetaxel plus carboplatin as neoadjuvant treatment for women with stage IIA–IIIC triple‑negative breast cancer. The primary outcome is the proportion of participants who achieve a pathological complete response at surgery. The study also collects blood samples to look for biomarker signals that may indicate resistance to the chemotherapy regimen. All participants will be enrolled and treated at sites in Nigeria with the University of Chicago serving as the coordinating center for data analysis.
Who should consider this trial
Good fit: Women aged 18–70 with biopsy-confirmed triple‑negative breast cancer, tumors ≥2 cm and measurable by ultrasound or core biopsy, clinical stage IIA–IIIC, chemotherapy‑naïve for this cancer, ECOG performance status 0–1, and not pregnant or breastfeeding are the intended participants.
Not a fit: Patients with metastatic disease, prior chemotherapy for this breast cancer, unacceptable blood counts or organ dysfunction, poor performance status, or who are pregnant or nursing are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the regimen could raise rates of complete tumor response before surgery and identify blood markers that predict which patients are unlikely to respond to standard chemotherapy.
How similar studies have performed: Other neoadjuvant trials in triple‑negative breast cancer have shown improved pathological complete response rates when platinum agents are added to anthracycline‑ and taxane‑based regimens, so this approach has prior supporting evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ikeja, Lagos and 3 other locations
- Lagos State University Teaching Hospital — Ikeja, Lagos, Nigeria (Recruiting)
- Lagos University Teaching Hospital — Yaba, Lagos, Nigeria (Recruiting)
- Obafemi Awolowo University Teaching Hospitals Complex — Ile-Ife, Osun State, Nigeria (Recruiting)
- University of Ibadan Hospital — Ibadan, Oyo State, Nigeria (Recruiting)
Study contacts
- Study coordinator: Ilona Siljander
- Email: isiljander1@bsd.uchicago.edu
- Phone: 773-834-6542
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.