Efficacy Study of Single Agent Trastuzumab or Lapatinib to Treat HER2-Overexpressing Breast Cancer

Sponsor
Azienda Ospedaliera Ordine Mauriziano di Torino
Study ID
NCT00842998
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab or Lapatinib — DRUG
    Trastuzumab: loading dose 8 mg/kg iv in 90 min.followed by weekly doses of 2 mg/kg Lapatinib: 1500 mg/die orally

Study Details

This study will evaluate the activity of single agent trastuzumab or lapatinib in patients not previously treated for HER-2 positive (FISH positive) metastatic breast cancer. A companion biological study will assess factors correlated with sensitivity or resistance to either one of the compounds

Key Dates

Start date
Feb 28, 2009
Status verified
Jun 2009
Primary completion
Dec 31, 2011
Completion
Dec 31, 2011

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1 - Trastuzumab
    Day1 Week1: 8 mg/kg iv in 90 min. Following 1st week: 2 mg/kg once/weekly for 8 weeks
  • Experimental: 2 - Lapatinib
    1500 mg/die orally

Primary Outcome Measure

Evidence of clinically definite response confirmed by CT or MRI [ Time Frame: 8 weeks ]

Central Contacts

Related Studies