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Phase I/II Study of Neoadjuvant Lapatinib in Breast Cancer

NCT00450892 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2016-07-07

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, fluorouracil, epirubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving these treatments before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving trastuzumab after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of docetaxel and lapatinib when given with or without combination chemotherapy and to see how well they work in treating women with locally advanced, inflammatory, or resectable breast cancer.

Conditions

Interventions

DRUG

docetaxel+lapatinib

3 cycles of docetaxel (100 mg/m²) + lapatinib (1000 mg/d) followed by 3 cycles of FEC

DRUG

docetaxel + trastuzumab

3 cycles of docetaxel (100 mg/m²) + trastuzumab weekly schedule followed by 3 cycles of FEC 100

DRUG

docetaxel + trastuzumab + lapatinib

3 cycles of docetaxel (100 mg/m²) + trastuzumab weekly schedule +lapatinib (1000 mg/d) followed by 3 cycles of FEC 100

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • David Cameron, MD · Edinburgh Cancer Centre at Western General Hospital

  • Herve Bonnefoi, MD · Institut Bergonié

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Belgium
  • France
  • Slovenia
  • Switzerland
  • United Kingdom

Study Locations

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Entities

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 NCT00450892 on ClinicalTrials.gov