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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
85
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 is given by intravenous (IV) infusion once every 3 weeks for 4 doses total (12 weeks). It will be given together with Cyclophosphamide.
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 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.
Participants will undergo breast surgery after completing dosing with Carboplatin and Docetaxel to remove any remaining cancer in the breast.
Capecitabine is a pill that will be taken by mouth daily for 6 months after surgery is completed.
Lagos State University Teaching Hospital
Ikeja, Lagos, Nigeria
RECRUITINGLagos University Teaching Hospital
Yaba, Lagos, Nigeria
RECRUITINGObafemi Awolowo University Teaching Hospitals Complex
Ile-Ife, Osun State, Nigeria
RECRUITINGUniversity of Ibadan Hospital
Ibadan, Oyo State, Nigeria
RECRUITINGPercentage 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.
Time frame: 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.
Time frame: 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.
Time frame: 4 - 6 months from start of chemotherapy
Side Effects of the Study Pre-surgery Chemotherapy Regimen
Percentage of participants experiencing Grades 3 and 4 blood, gastrointestinal, neurological and cardiovascular toxicities.
Time frame: After 8 cycles of treatment (24 weeks)
Clinical Response
Percentage of participants achieving clinical response (CR and PR) during neoadjuvant period by breast ultrasound
Time frame: 4 - 6 months from start of chemotherapy
Progressive Disease
Percentage of participants with progressive disease during pre-surgery treatment period
Time frame: After 8 cycles of treatment (24 weeks)
Invasive Disease Free Survival (iDFS)
Time to cancer returning or death
Time frame: 10 years from start of treatment
Duration of Response
Time to cancer worsening or death
Time frame: 10 years from start of treatment
Heart Related Side Effects of the Pre-Surgery Chemotherapy Regimen
Percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) and a decrease in left ventricular ejection fraction (LVEF) of at least 10 ejection fraction (EF) points from baseline and to below 50%.
Time frame: 10 years from start of treatment
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