NCT01593020View on ClinicalTrials.gov

Neoadjuvant Study of Sequential Eribulin Followed by FAC Compared to Sequential Paclitaxel Followed by FEC in Early Stage Breast Cancer Not Overexpressing HER-2

PHASE2CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

August 3, 2012

Primary Completion Date

November 4, 2020

Study Completion Date

November 4, 2020

Conditions
Breast Cancer
Interventions
DRUG

Paclitaxel

80 mg/m2 by vein over 1 hour on Days 1, 8, and 15 of each 21-day cycle.

DRUG

Eribulin

1.4 mg/m2 by vein over 2-5 minutes on Days 1 and 8 of each 21-day study cycle.

DRUG

5-Fluorouracil

500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.

DRUG

Epirubicin

100 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.

DRUG

Cyclophosphamide

500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.

DRUG

Doxorubicin

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.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT01593020 - Neoadjuvant Study of Sequential Eribulin Followed by FAC Compared to Sequential Paclitaxel Followed by FEC in Early Stage Breast Cancer Not Overexpressing HER-2 | Biotech Hunter | Biotech Hunter