Phase I/II Study of Neoadjuvant Lapatinib in Breast Cancer

Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Study ID
NCT00450892
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 28, 2007
Status verified
Jul 2016
Primary completion
Jul 31, 2013
Completion
Jul 31, 2013

Study Design

Enrollment
129 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: arm 1
  • Other: arm 2
  • Experimental: arm 3

Primary Outcome Measure

Phase I part: Dose limiting toxicity during cycle 1 [ Time Frame: during study ]

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