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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

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