Level of HER2-neu Gene Amplification an Response to Trastuzumab

Istituto Clinico Humanitas100 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Advanced Breast Cancer

Interventions

Fluorescent in-situ hybridization (FISH)GENETIC

Dual color FISH test to assess ratio of HER2/neu amplification

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Istituto Clinco Humanitas

Rozzano, Milan, Italy

RECRUITING

Outcomes

Primary Outcomes

Association of tumor cytogenetic paremeters with TTP and OS.

Time frame: one year

Secondary Outcomes

Association of cytogenetic parameters evalued by FISH test and patients' characteristics.

Time frame: one year

Central Contacts

Armando Santoro, MD

CONTACT

++39-028224 armando.santoro@humanitas.it

Giuseppe Gullo, MD

CONTACT

++39-028224 giuseppe.gullo@humanitas.it

Data from ClinicalTrials.gov

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