Combination chemotherapy for Nigerian women with triple-negative breast cancer.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Granzyme B-PET to see if immunotherapy works in TNBC

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.