Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

April 30, 2008

Primary Completion Date

October 31, 2008

Study Completion Date

September 30, 2010

Conditions
Breast Cancer
Interventions
DRUG

nab paclitaxel

100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle)

DRUG

Cyclophosphamide

600 mg/m2 of IV cyclophosphamide

DRUG

Trastuzumab

8 mg/kg loading dose of IV trastuzumab will be administered on Day 1, followed by doses of 6 mg/kg IV trastuzumab once every 3 weeks.

Trial Locations (10)

20817

Center for Cancer and Blood Disorders, Bethesda

23601

Peninsula Cancer Institute, Newport News

28801

Cancer Care of Western North Carolina, Asheville

33705

Gulfcoast Oncology Associates, St. Petersburg

33805

Watson Clinic Center for Cancer Care and Research, Lakeland

37023

Tennessee Oncology, PLLC, Nashville

40207

Consultants in Blood Disorders and Cancer, Louisville

49503

Grand Rapids Clinical Oncology Program, Grand Rapids

63017

St. Louis Cancer Care, Chesterfield

04101

Mercy Hospital, Portland

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER