Level of HER2-neu Gene Amplification an Response to Trastuzumab

Istituto Clinico Humanitas

Status: Unknown

Conditions: Advanced Breast Cancer

Treatments: Genetic: Fluorescent in-situ hybridization (FISH)

Study type: Observational

Funder types: Other

Identifiers

NCT00874146

ONC/OSS-03-2008

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

100 participants in 1 patient group

1

Description:

HER2-positive advanced breast cancer

Treatment:

Genetic: Fluorescent in-situ hybridization (FISH)