Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

April 30, 2004

Primary Completion Date

March 31, 2011

Study Completion Date

July 31, 2012

Conditions
Breast Cancer
Interventions
DRUG

Doxorubicin

60 mg/m2 IV, bolus once every 14 days x 2-4 cycles

DRUG

Cyclophosphamide

600 mg/m2 IV once every 14 days x 2-4 cycles

DRUG

Paclitaxel

80 mg/m2 IV over 1 hour once weekly for 9-12 doses beginning two weeks after completion of last AC dose

DRUG

Carboplatin

Area under the concentration curve (AUC) 2 IV once weekly for 9-12 doses beginning two weeks after completion of last AC dose

DRUG

GM-CSF

250 μg/mL IV on day 5-14 of each subcutaneous cycle of doxorubicin and injection cyclophosphamide

DRUG

Trastuzumab

AUC 2 IV weekly for 12-16 doses beginning two weeks after completion of last AC dose

Trial Locations (1)

92868

Chao Family Comprehensive Cancer Center, Orange

All Listed Sponsors
lead

Rita Sanghvi, Mehta

OTHER

NCT00256243 - Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer | Biotech Hunter | Biotech Hunter