Trial of Eribulin/Cyclophosphamide or Docetaxel/Cyclophosphamide as Neoadjuvant Therapy in Locally Advanced HER2-Negative Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

76

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

September 30, 2014

Study Completion Date

July 31, 2016

Conditions
HER2 Negative Breast Cancer
Interventions
DRUG

Eribulin

1.4 mg/m2 IV (Days 1 \& 8), given short (≤15 minute) IV infusion, per institutional standard

DRUG

Cyclophosphamide

Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard.

DRUG

Docetaxel

Patients assigned to Treatment Arm 2 will receive docetaxel 75 mg/m2 IV on Day 1 of each treatment cycle every 3 weeks.

Trial Locations (15)

20817

Center for Cancer and Blood Disorders, Bethesda

23230

Virginia Cancer Institute, Richmond

29210

South Carolina Oncology Associates, Columbia

30501

Northeast Georgia Medical Center, Gainesville

32503

Woodlands Medical Specialists, Pensacola

33021

Memorial Cancer Institute, Hollywood

33705

Florida Cancer Specialists North, St. Petersburg

33916

Florida Cancer Specialists South, Fort Myers

37203

Tennessee Oncology, Nashville

45242

Oncology Hematology Care, Inc, Cincinnati

49503

Grand Rapids Oncology Program, Grand Rapids

64132

Research Medical Center, Kansas City

68114

Nebraska Methodist Cancer Center, Omaha

76104

The Center for Cancer and Blood Disorders, Fort Worth

04102

Mercy Hospital, Portland

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER

NCT01527487 - Trial of Eribulin/Cyclophosphamide or Docetaxel/Cyclophosphamide as Neoadjuvant Therapy in Locally Advanced HER2-Negative Breast Cancer | Biotech Hunter | Biotech Hunter