Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer

NCT06291064 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB23-0678
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 4

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.

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  4 - 6 months from start of chemotherapy

Secondary Outcomes (6)

• Side Effects of the Study Pre-surgery Chemotherapy Regimen

  After 8 cycles of treatment (24 weeks)

• Clinical Response

  4 - 6 months from start of chemotherapy

• Progressive Disease

  After 8 cycles of treatment (24 weeks)

• Invasive Disease Free Survival (iDFS)

  10 years from start of treatment

• Duration of Response

  10 years from start of treatment

Study Arms (1)

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.

Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Docetaxel; Drug: Carboplatin; Procedure: Breast Surgery; Drug: Capecitabine

Interventions

Cyclophosphamide DRUG

Cyclophosphamide is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Epirubicin.

Treatment Arm

Epirubicin DRUG

Epirubicin is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Cyclophosphamide.

Treatment Arm

Docetaxel DRUG

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.

Treatment Arm

Carboplatin DRUG

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.

Treatment Arm

Breast Surgery PROCEDURE

Participants will undergo breast surgery after completing dosing with Carboplatin and Docetaxel to remove any remaining cancer in the breast.

Treatment Arm

Capecitabine DRUG

Capecitabine is a pill that will be taken by mouth daily for 6 months after surgery is completed.

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Study will enroll women with breast cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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
• \. 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%

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (4)

Lagos State University Teaching Hospital

Ikeja, Lagos, 100271, Nigeria

RECRUITING

Lagos University Teaching Hospital

Yaba, Lagos, 100254, Nigeria

RECRUITING

Obafemi Awolowo University Teaching Hospitals Complex

Ile-Ife, Osun State, 220005, Nigeria

RECRUITING

University of Ibadan Hospital

Ibadan, Oyo State, 200285, Nigeria

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Cyclophosphamide; Epirubicin; Docetaxel; Carboplatin; Mastectomy, Segmental; Capecitabine

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Coordination Complexes; Mastectomy; Surgical Procedures, Operative; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Olufunmilayo Olopade, MD

  University of Chicago

  STUDY CHAIR

Central Study Contacts

Ilona Siljander

CONTACT

773-834-6542; isiljander1@bsd.uchicago.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 4, 2024
• Study Start: March 18, 2025
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2032
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

NG (4)