Level of HER2-neu Gene Amplification an Response to Trast... | NCT00874146

Studies
Level of HER2-neu Gene Amplification an Response to Trastuzumab

NCT00874146

Sponsor

Istituto Clinico Humanitas

Status

Unknown status

Last Update Posted

Sep 2, 2010Estimated

Enrollment

100Estimated

Phase

Not provided

Conditions

Advanced Breast Cancer

Interventions

Fluorescent in-situ hybridization (FISH)

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Sep 2009Actual

Completion Date

Dec 2009Estimated

First Submitted Date

Mar 26, 2009

First Submission Date that Met QC Criteria

Apr 1, 2009

First Posted Date

Apr 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2010

Last Update Posted Date

Sep 2, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		HER2-positive advanced breast cancer	Genetic: Fluorescent in-situ hybridization (FISH)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fluorescent in-situ hybridization (FISH)	Genetic	Dual color FISH test to assess ratio of HER2/neu amplification	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Armando Santoro, MD	Contact	++39-028224	4080	armando.santoro@humanitas.it
Giuseppe Gullo, MD	Contact	++39-028224	4080	giuseppe.gullo@humanitas.it

Overall Officials

Name	Affiliation	Role
Armando Santoro, MD	Istituto Clinico Humanitas	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto Clinco Humanitas	Recruiting	Rozzano	Milan	20089	Italy

Intervention Browse Module

MeSH Terms

ID	Term
D017404	In Situ Hybridization, Fluorescence

Ancestor Terms

ID	Term
D017403	In Situ Hybridization
D013194	Staining and Labeling
D016591	Histocytological Preparation Techniques
D003584	Cytological Techniques

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Not provided

Browse Branches

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