Phase II Neoadjuvant in Inflammatory Breast Cancer

PHASE2TerminatedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

October 31, 2008

Primary Completion Date

October 31, 2013

Study Completion Date

October 31, 2013

Conditions
Breast Cancer
Interventions
DRUG

Lapatinib

1000 mg taken by every day by mouth (PO) weeks 1 and 2; then starting day 15 for 12 weeks (weeks 3 to 14) daily 750 mg PO. Week 15, second combination treatment consisting of lapatinib (1,000 mg orally once daily) combined with FEC7.

DRUG

Paclitaxel

80 mg/m\^2 intravenously over 1 hour weekly for 4 cycles administered on Day 1, Day 8, and Day 15 of each cycle then weekly starting day 15 for 12 weeks.

DRUG

5-Fluorouracil (5-FU)

500 mg/m\^2 intravenously over 3-5 minutes every three weeks of Weeks 13-24.

DRUG

Epirubicin

75 mg/m\^2 intravenously over 5-10 minutes every three weeks of Weeks 13-24.

DRUG

Cyclophosphamide

500 mg/m\^2 intravenously over 45-60 minutes every three weeks of Weeks 13-24.

Trial Locations (1)

77030

UT MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER