Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer

Trial Title: Trial Studying Chemotherapy in Nigerian Women With Triple Negative Breast Cancer

NCT ID: NCT06291064

Condition: Triple Negative Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Cyclophosphamide
Carboplatin
Docetaxel
Capecitabine
Epirubicin

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Cyclophosphamide
Description: Cyclophosphamide is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Epirubicin.
Arm group label: Treatment Arm

Intervention type: Drug
Intervention name: Epirubicin
Description: Epirubicin is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Cyclophosphamide.
Arm group label: Treatment Arm

Intervention type: Drug
Intervention name: Docetaxel
Description: 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.
Arm group label: Treatment Arm

Intervention type: Drug
Intervention name: Carboplatin
Description: 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.
Arm group label: Treatment Arm

Intervention type: Procedure
Intervention name: Breast Surgery
Description: Participants will undergo breast surgery after completing dosing with Carboplatin and Docetaxel to remove any remaining cancer in the breast.
Arm group label: Treatment Arm

Intervention type: Drug
Intervention name: Capecitabine
Description: Capecitabine is a pill that will be taken by mouth daily for 6 months after surgery is completed.
Arm group label: Treatment Arm

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.

Criteria for 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.

Gender: Female

Gender based: Yes

Gender description: Study will enroll women with breast cancer.

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Start date: November 2024

Completion date: June 2032

Lead sponsor:
Agency: University of Chicago
Agency class: Other

Source: University of Chicago

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06291064