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

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ClinicalTrials.gov Identifier: NCT00740532
Recruitment Status : Completed
First Posted : August 25, 2008
Last Update Posted : September 2, 2010
Sponsor:
Information provided by:
Istituto Clinico Humanitas

Brief Summary:

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.


Condition or disease Intervention/treatment
Breast Cancer Genetic: Gene mutation analyses and FISH

Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Study Assessing Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients
Study Start Date : October 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Association of a specific biomarker with response to Herceptin-based therapy [ Time Frame: Response after two months of treatment ]

Secondary Outcome Measures :
  1. Association of a specific biomarker with time to progression survival and patient's characteristics [ Time Frame: At the end of enrollment ]

Biospecimen Retention:   Samples With DNA
Paraffine embedded tumor sections


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
Breast cancer patients treated with Herceptin-based therapy
Criteria

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

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): NCT00740532


Locations
Italy
Istituto Clinico Humanitas
Rozzano, Milan, Italy, 20089
Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas

Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00740532     History of Changes
Other Study ID Numbers: ONC/OSS-01/2007
First Posted: August 25, 2008    Key Record Dates
Last Update Posted: September 2, 2010
Last Verified: September 2010

Keywords provided by Istituto Clinico Humanitas:
EGFR, HER-2, HER-3, MET, KRAS

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