Lapatinib and Epirubicin in Treating Patients With Metastatic Breast Cancer. ICORG 06-30

Sponsor
Cancer Trials Ireland
Study ID
NCT00753207
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • epirubicin hydrochloride — DRUG
  • lapatinib ditosylate — DRUG
  • biomarker analysis — OTHER
  • immunohistochemistry staining method — OTHER
  • liquid chromatography — OTHER
  • mass spectrometry — OTHER

Study Details

RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving lapatinib together with epirubicin may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of epirubicin when given together with lapatinib in treating patients with metastatic breast cancer.

Key Dates

Start date
Oct 31, 2007
Status verified
Jan 2014
Primary completion
Nov 30, 2008
Completion
Mar 31, 2012

Study Design

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

Arms

  • Experimental: Lapatinib and Epirubicin
    Fixed dose of lapatinib in combination with escalating dose of epirubicin.

Primary Outcome Measure

Optimally-tolerated regimen of lapatinib ditosylate in combination with epirubicin hydrochloride [ Time Frame: 2012 ]

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