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

This study has been completed.
Sponsor:
Information provided by:
Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:
NCT00740532
First received: August 22, 2008
Last updated: September 1, 2010
Last verified: September 2010
  Purpose

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 Intervention
Breast Cancer
Genetic: Gene mutation analyses and FISH

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Observational Study Assessing Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Istituto Clinico Humanitas:

Primary Outcome Measures:
  • Association of a specific biomarker with response to Herceptin-based therapy [ Time Frame: Response after two months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Association of a specific biomarker with time to progression survival and patient's characteristics [ Time Frame: At the end of enrollment ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Paraffine embedded tumor sections


Enrollment: 11
Study Start Date: October 2007
Study Completion Date: August 2010
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observation
Breast cancer patients treated with Herceptin-based therapy
Genetic: Gene mutation analyses and FISH
FISH and mutation analyses of multiple genes

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT00740532     History of Changes
Other Study ID Numbers: ONC/OSS-01/2007
Study First Received: August 22, 2008
Last Updated: September 1, 2010
Health Authority: Italy: Ministry of Health

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014