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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00740532
• Other study ID #: ONC/OSS-01/2007
• Status: Completed
• Phase: N/A
• First received: August 22, 2008
• Last updated: September 1, 2010
• Start date: October 2007
• Est. completion date: August 2010

Study information

• Verified date: September 2010
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 2010
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• Gene mutation analyses and FISH
FISH and mutation analyses of multiple genes

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association of a specific biomarker with response to Herceptin-based therapy		Response after two months of treatment	No
Secondary	Association of a specific biomarker with time to progression survival and patient's characteristics		At the end of enrollment	No