Study of Neoadjuvant Carboplatin, Eribulin and Trastuzumab for Operable HER2 Positive Breast Cancer

PHASE1/PHASE2TerminatedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

August 31, 2011

Primary Completion Date

June 30, 2014

Study Completion Date

September 30, 2014

Conditions
HER-2 Positive Breast Cancer
Interventions
DRUG

eribulin

During Phase I, the eribulin dose will be assigned upon study enrollment. The maximum tolerated dose (MTD) determined in Phase I will be the dose used for Phase II. Eribulin will be administered intravenously (IV) over 2 to 5 minutes on Days 1 and 8 of each cycle.

DRUG

carboplatin

Carboplatin area under the curve (AUC) 6 will be administered IV over 15 to 30 minutes on Day 1 of each cycle.

DRUG

trastuzumab

Trastuzumab will be administered as an IV infusion on Day 1 of each cycle. A loading dose of 8 mg/kg of trastuzumab will be administered over 90 minutes on Cycle 1 Day 1. Then, a maintenance dose of 6 mg/kg of trastuzumab will be administered over 30 to 90 minutes on Day 1 of Cycles 2 - 6.

Trial Locations (4)

30060

Northwest Georgia Oncology Centers, Marietta

30607

Northeast Georgia Cancer Care, Athens

33308

Holy Cross Hospital, Fort Lauderdale

38120

The West Clinic, Memphis

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

Vector Oncology

OTHER

NCT01388647 - Study of Neoadjuvant Carboplatin, Eribulin and Trastuzumab for Operable HER2 Positive Breast Cancer | Biotech Hunter | Biotech Hunter