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Phase II Neoadjuvant in Inflammatory Breast Cancer

NCT00756470 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2014-11-17

Study results available
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Summary

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.

Conditions

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.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Ricardo Alvarez, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00756470 on ClinicalTrials.gov