Phase II Neoadjuvant in Inflammatory Breast Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00756470
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Lapatinib — DRUG
    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.
  • Paclitaxel — DRUG
    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.
  • 5-Fluorouracil (5-FU) — DRUG
    500 mg/m\^2 intravenously over 3-5 minutes every three weeks of Weeks 13-24.
  • Epirubicin — DRUG
    75 mg/m\^2 intravenously over 5-10 minutes every three weeks of Weeks 13-24.
  • Cyclophosphamide — DRUG
    500 mg/m\^2 intravenously over 45-60 minutes every three weeks of Weeks 13-24.

Study Details

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 Inflammatory Breast Cancer (IBC). The safety of this drug combination will also be studied.

Key Dates

Start date
Oct 31, 2008
Status verified
Nov 2014
Primary completion
Oct 31, 2013
Completion
Oct 31, 2013

Study Design

Enrollment
15 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant Lapatinib plus Chemotherapy
    Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days. Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each. 1. Week 3 Paclitaxel 80 mg/m\^2 weekly for 4 cycles (12 weeks) administered on Day 1, Day 8, and Day 15) of each cycle combined with Lapatinib 750 mg orally once daily. 2. Week 15, second combination treatment consisting of Lapatinib (1,000 mg orally once daily) combined with FEC75 (5-FU 500 mg/m\^2, Epirubicin 75 mg/m\^2, and Cyclophosphamide 500 mg/m\^2 every 3 weeks for 4 cycles).

Primary Outcome Measure

Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy [ Time Frame: Assessed at time of surgery following completion neoadjuvant chemotherapy (approximately 26 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UT MD Anderson Cancer Center· Houston, TX

Related Studies