Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients

September 1, 2010 updated by: Istituto Clinico Humanitas

Observational Study Assessing Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients

Aim of the study is to assess the impact on response to Herceptin-based therapy in patients with advanced breast cancer. Tumor specimens from primary breast cancer will be analized for several biological factors potentially involved in Herceptin sensitivity.

Tests that will be performed include: FISH analyses of EGFR, HER-2, HER-3, C-MYC, PTEN, MET, IGFR-1. Immunofluorecence of P95HER2. Mutation analyses of EGFR, HER-2, MET, C-MYC, PTEN, KRAS, PIK3CA, IGFR-1. Immunohistochemistry of the same biomarkers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

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
        • Istituto Clinico Humanitas

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

Breast cancer patients treated with Herceptin-based therapy

Description

Inclusion Criteria:

  • Hystological diagnosis of breast cancer
  • Availability of tumor tissue
  • Availability to assess the response to Trastuzumab according to RECIST criteria
  • Availability of clinical data

Exclusion Criteria:

  • Unavailability of tumor tissue
  • Impossibility to assess the response to Trastuzumab according to RECIST criteria

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observation
Breast cancer patients treated with Herceptin-based therapy
Genetic: Gene mutation analyses and FISH
FISH and mutation analyses of multiple genes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Association of a specific biomarker with response to Herceptin-based therapy
Time Frame: Response after two months of treatment
Response after two months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Association of a specific biomarker with time to progression survival and patient's characteristics
Time Frame: At the end of enrollment
At the end of enrollment

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

October 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

August 22, 2008

First Submitted That Met QC Criteria

August 22, 2008

First Posted (Estimate)

August 25, 2008

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONC/OSS-01/2007

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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