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Trial Title:
Efficacy Study of Single Agent Trastuzumab or Lapatinib to Treat HER2-Overexpressing Breast Cancer
NCT ID:
NCT00842998
Condition:
Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Trastuzumab
Lapatinib
Conditions: Keywords:
breast cancer
HER2
Trastuzumab
Lapatinib
HER2 gene-amplification
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Trastuzumab or Lapatinib
Description:
Trastuzumab: loading dose 8 mg/kg iv in 90 min.followed by weekly doses of 2 mg/kg
Lapatinib: 1500 mg/die orally
Arm group label:
1 - Trastuzumab
Arm group label:
2 - Lapatinib
Summary:
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
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Women aged 18-75 years
- Histologically or cytologically confirmed metastatic disease.
- HER2-Overexpression proven by Fluorescence in Situ Hybridization (FISH).
- Availability of paraffin-embedded block of either primitive tumor and/or biopsy of
metastases.
- No prior chemotherapy for metastatic or locally advanced disease. Patients with
hormone receptor (oestrogen and/or progesterone) positive breast cancer can be
eligible provided that they had received only ONE line of hormonal therapy for
metastatic disease.
- For patients undergoing hormonal therapy for metastatic disease, disease progression
must be confirmed according to RECIST criteria.
- At least 20% increase in the sum of longest diameters, OR
- Evidence of new metastatic lesions or progression of pre-existing non-target
lesions.
- Presence of at least one monodimensionally measurable lesion. Patients without
clinically or radiologically proven evidence of disease are not eligible.
- Patients with exclusively skin disease are eligible, provided that the disease
evolution under treatment can be photographically documented.
- Patients with involvement of NCS, besides presence of measurable lesions, are
eligible provided that:
- Brain lesion/s has/have been radically resected;
- Brain lesion/s has/have obtained complete remission following radiation
therapy. Complete remission must be documented by TC or RMN.
- At least 4-week interval from end of radiotherapy, hormono- or immunotherapy and
enrollment in this study.
- ECOG PS 30% dof hepatic volume, etc).
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
U.O. Oncologia Medica - Ospedale San Luigi
Address:
City:
Orbassano
Zip:
10043
Country:
Italy
Status:
Active, not recruiting
Facility:
Name:
Institute for Cancer Research and Treatment (I.R.C.C.)
Address:
City:
Candiolo , Torino
Zip:
10060
Country:
Italy
Status:
Recruiting
Investigator:
Last name:
Filippo Montemurro, MD
Email:
Principal Investigator
Facility:
Name:
U.O. Oncologia Medica
Address:
City:
Cuneo
Zip:
12100
Country:
Italy
Status:
Active, not recruiting
Facility:
Name:
U.O. Oncologia Medica - COES Molinette
Address:
City:
Torino
Zip:
10126
Country:
Italy
Status:
Active, not recruiting
Start date:
February 2009
Completion date:
December 2011
Lead sponsor:
Agency:
Azienda Ospedaliera Ordine Mauriziano di Torino
Agency class:
Other
Source:
Azienda Ospedaliera Ordine Mauriziano di Torino
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00842998
