Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer

NCT ID: NCT06291064

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2032-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

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.

Group Type: EXPERIMENTAL

Cyclophosphamide

Intervention Type: 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.

Epirubicin

Intervention Type: 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.

Docetaxel

Intervention Type: 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.

Carboplatin

Intervention Type: 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.

Breast Surgery

Intervention Type: PROCEDURE

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

Capecitabine

Intervention Type: DRUG

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

Interventions

Cyclophosphamide

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

Intervention Type: DRUG

Epirubicin

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

Intervention Type: DRUG

Docetaxel

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.

Intervention Type: DRUG

Carboplatin

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.

Intervention Type: DRUG

Breast Surgery

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

Intervention Type: PROCEDURE

Capecitabine

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olufunmilayo Olopade, MD

Role: STUDY_CHAIR

University of Chicago

Locations

Lagos State University Teaching Hospital

Ikeja, Lagos, Nigeria

Lagos University Teaching Hospital

Yaba, Lagos, Nigeria

Obafemi Awolowo University Teaching Hospitals Complex

Ile-Ife, Osun State, Nigeria

University of Ibadan Hospital

Ibadan, Oyo State, Nigeria

Countries

Nigeria

Central Contacts

Ilona Siljander

Role: CONTACT

isiljander1@bsd.uchicago.edu

773-834-6542

Other Identifiers

IRB23-0678

Identifier Type: -

Identifier Source: org_study_id