Neoadjuvant Ixabepilone/Carboplatin/Trastuzumab in HER2-Positive Locally Advanced Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

July 31, 2011

Study Completion Date

October 31, 2014

Conditions
Breast Cancer
Interventions
DRUG

Ixabepilone

Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)

DRUG

Trastuzumab

Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52

DRUG

Carboplatin

Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)

Trial Locations (12)

20817

Center for Cancer and Blood Disorders, Bethesda

National Capital Clinical Research Consortium, Bethesda

23235

Virginia Cancer Institute, Richmond

30901

Medical Oncology Associates of Augusta, Augusta

33901

Florida Cancer Specialists, Fort Myers

37023

Tennessee Oncology, PLLC, Nashville

45242

Oncology Hematology Care, Cincinnati

47802

Providence Medical Group, Terre Haute

49503

Grand Rapids Clinical Oncology Program, Grand Rapids

63017

St. Louis Cancer Care, Chesterfield

04101

Mercy Hospital, Portland

07960

Hematology Oncology Associates of Northern NJ, Morristown

Sponsors
All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

collaborator

Genentech, Inc.

INDUSTRY

lead

SCRI Development Innovations, LLC

OTHER