At a glance
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A Randomized Phase II Neoadjuvant Study of Sequential Eribulin Followed by FAC/FEC-regimen Compared to Sequential Paclitaxel Followed by FAC/FEC-Regimen in Women With Early Stage Breast Cancer Not Overexpressing HER-2
In Brief
A Phase 2 clinical trial evaluating Paclitaxel, Eribulin, and 4 other interventions for Breast Cancer. Completed, enrolled 54 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if and how well eribulin, given in combination with standard chemotherapy, can treat early-stage breast cancer compared to paclitaxel given in combination with standard chemotherapy. In this study, the standard chemotherapy being given is either 5-fluorouracil, epirubicin, and cyclophosphamide (called FEC) or 5-fluorouracil, doxorubicin, and cyclophosphamide (called FAC). Eribulin is a changed version of the structure of a natural substance from a sea sponge. It is designed to block cells from dividing, which may cause cancer cells to die. Paclitaxel is designed to block cancer cells from dividing, which may cause them to die. 5-fluorouracil is designed to block cancer cells from growing and dividing, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die. Epirubicin is designed to block the way cancer cells grow and divide, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die. Doxorubicin is designed to stop the growth of cancer cells, which may cause the cells to die. Cyclophosphamide is designed to interfere with the multiplication of cancer cells, which may slow or stop their growth and/or keep them from spreading throughout the body. This may cause the cancer cells to die.
Study Details
Timeline
Interventions
80 mg/m2 by vein over 1 hour on Days 1, 8, and 15 of each 21-day cycle.
1.4 mg/m2 by vein over 2-5 minutes on Days 1 and 8 of each 21-day study cycle.
500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.
100 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.
500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.
50 mg/m2 by vein on day 1, over 72 hour continuous infusion or intravenous bolus, for 4 cycles (21 day cycle) at preference of treating physicians.