Level of HER2-neu Gene Amplification an Response to Trastuzumab

September 1, 2010 updated by: Istituto Clinico Humanitas

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milan
      • Rozzano, Milan, Italy, 20089
        • Recruiting
        • Istituto Clinco Humanitas
        • Contact:
        • Sub-Investigator:
          • Giuseppe Gullo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimen.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
HER2-positive advanced breast cancer
Genetic: Fluorescent in-situ hybridization (FISH)
Dual color FISH test to assess ratio of HER2/neu amplification

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Association of tumor cytogenetic paremeters with TTP and OS.
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
Association of cytogenetic parameters evalued by FISH test and patients' characteristics.
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ANTICIPATED)

December 1, 2009

Study Registration Dates

First Submitted

March 26, 2009

First Submitted That Met QC Criteria

April 1, 2009

First Posted (ESTIMATE)

April 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2010

Last Update Submitted That Met QC Criteria

September 1, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONC/OSS-03-2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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