Actively Recruiting
Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer
Led by University of Chicago · Updated on 2026-02-17
85
Participants Needed
4
Research Sites
376 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women ages of 18 to 70 years old
- Able and willing to read, understand, and sign an informed consent document
- Biopsy-accessible breast tumor of significant size for core needle biopsy or ultrasound measurable (≥ 2 cm)
- Histologically confirmed carcinoma of the female breast with triple-negative status by immunohistochemistry (IHC), including low estrogen receptor expression (< 20%), progesterone receptor negative, and HER2 negative
- Clinical stages IIA to IIIC (AJCC 2009)
- Chemotherapy-naïve patients for this cancer
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Not pregnant and not nursing
- Granulocyte count ≥ 1,500/microliter
- Platelet count ≥ 100,000/microliter
- Absolute neutrophil count (ANC) ≥ 1,500/microliter
- Hemoglobin ≥ 10 g/dL
- Bilirubin ≤ 1.5 x upper limit of normal
- Aspartate aminotransferase (ALT or SGOT) and alanine transaminase (AST or SGPT) < 2.5 x upper limit of normal
- Creatinine within institutional normal limits or glomerular filtration rate ≥ 30 mL/min/1.73 m2 by CKD EPI equation
- Baseline left ventricular ejection fraction ≥ 55%
You will not qualify if you...
- Pregnant or lactating women
- Patients with distant metastasis including brain and/or visceral metastasis
- Serious, uncontrolled, concurrent infections
- 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 before starting study treatment
- Other serious uncontrolled medical conditions that might compromise study participation, including but not limited to chronic or active infection, HIV-positive status, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled diabetes, or psychiatric illness/social situations limiting compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Lagos State University Teaching Hospital
Ikeja, Lagos, Nigeria, 100271
Actively Recruiting
2
Lagos University Teaching Hospital
Yaba, Lagos, Nigeria, 100254
Actively Recruiting
3
Obafemi Awolowo University Teaching Hospitals Complex
Ile-Ife, Osun State, Nigeria, 220005
Actively Recruiting
4
University of Ibadan Hospital
Ibadan, Oyo State, Nigeria, 200285
Actively Recruiting
Research Team
I
Ilona Siljander
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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