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Level of HER2-neu Gene Amplification an Response to Trastuzumab

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by Istituto Clinico Humanitas.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00874146
First Posted: April 2, 2009
Last Update Posted: September 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Istituto Clinico Humanitas
  Purpose
Primary objective of the study is to evaluate the correlation between level of HER2-neu gene amplification evalued by dual-color Fluorescent in-situ hybridization (FISH) test and time to progression (TTP) in patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimens.

Condition Intervention
Advanced Breast Cancer Genetic: Fluorescent in-situ hybridization (FISH)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study of the Level of HER2-neu Gene Amplification as Predictive Factor of Response in Patients With HER2-positive Advanced Breast Cancer Treated With Trastuzumab Containing Regimens.

Resource links provided by NLM:


Further study details as provided by Istituto Clinico Humanitas:

Primary Outcome Measures:
  • Association of tumor cytogenetic paremeters with TTP and OS. [ Time Frame: one year ]

Secondary Outcome Measures:
  • Association of cytogenetic parameters evalued by FISH test and patients' characteristics. [ Time Frame: one year ]

Biospecimen Retention:   Samples With DNA
FISH test performed on paraffine embedded tumor sections.

Estimated Enrollment: 100
Study Start Date: March 2009
Estimated Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
HER2-positive advanced breast cancer
Genetic: Fluorescent in-situ hybridization (FISH)
Dual color FISH test to assess ratio of HER2/neu amplification

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimen.
Criteria

Inclusion Criteria:

  • HER2-positive breast cancer Trastuzumab-containing regimen delivered for advanced disease Tumor sample available at Pathology Archive

Exclusion Criteria:

  • HER2-negative advanced breast cancer Pretreatment with trastuzumab
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874146


Contacts
Contact: Armando Santoro, MD ++39-028224 ext 4080 armando.santoro@humanitas.it
Contact: Giuseppe Gullo, MD ++39-028224 ext 4080 giuseppe.gullo@humanitas.it

Locations
Italy
Istituto Clinco Humanitas Recruiting
Rozzano, Milan, Italy, 20089
Contact: Armando Santoro, MD    +39028224 ext 4080    armando.santoro@humanitas.it   
Contact: Giuseppe Gullo, MD    +39028224 ext 4080    giuseppe.gullo@humanitas.it   
Sub-Investigator: Giuseppe Gullo, MD         
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
  More Information

Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00874146     History of Changes
Other Study ID Numbers: ONC/OSS-03-2008
First Submitted: March 26, 2009
First Posted: April 2, 2009
Last Update Posted: September 2, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents