Level of HER2-neu Gene Amplification an Response to Trastuzumab

Retrospective Study of the Level of HER2-neu Gene Amplification as Predictive Factor of Response in Patients With HER2-positive Advanced Breast Cancer Treated With Trastuzumab Containing Regimens.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00874146

Enrollment

100

Registered

2009-04-02

Start date

2009-03-31

Completion date

2009-12-31

Last updated

2010-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Breast Cancer

Brief summary

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.

Interventions

GENETICFluorescent in-situ hybridization (FISH)

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Association of tumor cytogenetic paremeters with TTP and OS.	one year

Secondary

Measure	Time frame
Association of cytogenetic parameters evalued by FISH test and patients' characteristics.	one year

Countries

Italy

Contacts

Primary ContactArmando Santoro, MD

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

Backup ContactGiuseppe Gullo, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026