NCT06291064 Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer
| NCT ID | NCT06291064 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Chicago |
| Condition | Triple Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 85 participants |
| Start Date | 2025-03-18 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 85 participants in total. It began in 2025-03-18 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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.
Contact & Investigator
Olufunmilayo Olopade, MD
STUDY CHAIR
University of Chicago
Frequently Asked Questions
Who can join the NCT06291064 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Triple Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06291064 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06291064 currently recruiting?
Yes, NCT06291064 is actively recruiting participants. Contact the research team at isiljander1@bsd.uchicago.edu for enrollment information.
Where is the NCT06291064 trial being conducted?
This trial is being conducted at Ikeja, Nigeria, Yaba, Nigeria, Ile-Ife, Nigeria, Ibadan, Nigeria.
Who is sponsoring the NCT06291064 clinical trial?
NCT06291064 is sponsored by University of Chicago. The principal investigator is Olufunmilayo Olopade, MD at University of Chicago. The trial plans to enroll 85 participants.
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