Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

December 31, 2010

Study Completion Date

March 31, 2011

Conditions
Breast CancerMetastatic Breast Cancer
Interventions
DRUG

Lapatinib

1250 mg, tablets, oral daily during treatment with docetaxel (3-week cycles x 4 cycles)

DRUG

Doxorubicin

60 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with cyclophosphamide.

DRUG

Cyclophosphamide

600 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with doxorubicin.

DRUG

Docetaxel

100 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide

DRUG

Pegfilgrastim

6 mg, subcutaneously on day 2 of all cytotoxic chemotherapy treatments.

DRUG

Filgrastim

300 or 480 mcg, subcutaneously on days 3 to 10 after cytotoxic chemotherapies.

DRUG

Dexamethasone

8 mg, oral taken twice a day for 3 days starting 24 hours before docetaxel

DRUG

Trastuzumab

Loading dose 8 mg/kg, then 6 mg/kg, intravenously every 3 weeks for 1 year

Trial Locations (2)

94305

Stanford University School of Medicine, Stanford

95128

Santa Clara Valley Medical Center, San Jose

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

Sanofi

INDUSTRY

lead

George Albert Fisher

OTHER