Level of HER2-neu Gene Amplification an Response to Trastuzumab - Full Text View

Sponsored by:	Istituto Clinico Humanitas
Information provided by:	Istituto Clinico Humanitas
ClinicalTrials.gov Identifier:	NCT00874146

Purpose

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.

Condition	Intervention
Advanced Breast Cancer	Genetic: Fluorescent in-situ hybridization (FISH)

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	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.

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Trastuzumab

U.S. FDA Resources

Further study details as provided by Istituto Clinico Humanitas:

Primary Outcome Measures:

Association of tumor cytogenetic paremeters with TTP and OS. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Association of cytogenetic parameters evalued by FISH test and patients' characteristics. [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

FISH test performed on paraffine embedded tumor sections.

Estimated Enrollment:	100
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 HER2-positive advanced breast cancer	Genetic: Fluorescent in-situ hybridization (FISH) Dual color FISH test to assess ratio of HER2/neu amplification

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

Patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimen.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00874146

Locations

Italy, Milan
Istituto Clinco 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:	Istituto Clinico Humanitas ( Armando Santoro, MD )
Study ID Numbers:	ONC/OSS-03-2008
Study First Received:	March 26, 2009
Last Updated:	August 27, 2009
ClinicalTrials.gov Identifier:	NCT00874146 History of Changes
Health Authority:	Italy: Ministry of Health

Study placed in the following topic categories:

Skin Diseases
Trastuzumab
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Trastuzumab
Breast Neoplasms
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on September 11, 2009