Multimodality Treatment for Women With Stage II, Stage III, or Stage IV Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

82

Participants

Timeline

Start Date

December 31, 1998

Primary Completion Date

March 31, 2012

Study Completion Date

April 30, 2013

Conditions
Breast Cancer
Interventions
BIOLOGICAL

trastuzumab

infusion 4 mg/kg load week 1; 2 mg/kg weekly thereafter for 12 weeks

DRUG

cyclophosphamide

600 mg/m2, intravenous infusion every 3 weeks for four cycles

DRUG

doxorubicin hydrochloride

60 mg/m2 intravenously, 5-10 minutes, every 3 weeks, up to 12 weeks

DRUG

paclitaxel

90 mg/m2 weekly, intravenously 1 hour after herceptin, given weekly up to 12 weeks or 175 mg/m2, intravenously every 3 weeks, up to 12 weeks (only if not receiving Herceptin®)

PROCEDURE

conventional surgery

Surgical excision will take place 12-13 weeks for the neo-adjuvant herceptin setting and 12-13 weeks in the non-herceptin setting. Surgery will take place prior to chemotherapy in the adjuvant herceptin setting

Trial Locations (2)

27599-7305

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill

27157-1082

Comprehensive Cancer Center at Wake Forest University, Winston-Salem

All Listed Sponsors
lead

UNC Lineberger Comprehensive Cancer Center

OTHER

NCT00006110 - Multimodality Treatment for Women With Stage II, Stage III, or Stage IV Breast Cancer | Biotech Hunter | Biotech Hunter