Phase II Neoadjuvant in Inflammatory Breast Cancer
The goal of this clinical research study is to learn how well lapatinib taken alone, followed by taking lapatinib with paclitaxel, and then taking lapatinib with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC75) works to help to control IBC. The safety of this drug combination will also be studied.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Neoadjuvant Lapatinib Plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women With Inflammatory Breast Cancer Whose Tumors Overexpress ErbB2 (Her2/Neu)|
- Rate of pCR after completion of all protocol specified therapy (Four cycles of lapatinib and paclitaxel followed by 4 cycles of lapatinib plus FEC75) [ Time Frame: At time of surgery following completion neoadjuvant chemotherapy (approximately 26 weeks) ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2008|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Neoadjuvant Lapatinib plus Chemotherapy
Four cycles of lapatinib and paclitaxel followed by 4 cycles of lapatinib plus FEC75.
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.
Other Names:Drug: Paclitaxel
80 mg/m^2 intravenously over 1 hour weekly x 4 cycles administered on Day 1, Day 8, and Day 15 of each cycle then weekly starting day 15 for 12 weeks.
Other Name: TaxolDrug: 5-Fluorouracil
500 mg/m^2 intravenously over 3-5 minutes every three weeks of Weeks 13-24.
Other Names: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.
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ricardo Alvarez, MD||M.D. Anderson Cancer Center|