Molecular Features Predicting Response/Resistance to Tras... | NCT00740532

Studies
Molecular Features Predicting Response/Resistance to Trastuzumab in Metastatic Breast Cancer Patients

NCT00740532

Sponsor

Istituto Clinico Humanitas

Status

Completed

Last Update Posted

Sep 2, 2010Estimated

Enrollment

11Actual

Phase

Not provided

Conditions

Breast Cancer

Interventions

Gene mutation analyses and 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

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Mar 2008Actual

Completion Date

Aug 2010Actual

First Submitted Date

Aug 22, 2008

First Submission Date that Met QC Criteria

Aug 22, 2008

First Posted Date

Aug 25, 2008Estimated

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

Aim of the study is to assess the impact on response to Herceptin-based therapy in patients with advanced breast cancer. Tumor specimens from primary breast cancer will be analized for several biological factors potentially involved in Herceptin sensitivity.

Tests that will be performed include: FISH analyses of EGFR, HER-2, HER-3, C-MYC, PTEN, MET, IGFR-1. Immunofluorecence of P95HER2. Mutation analyses of EGFR, HER-2, MET, C-MYC, PTEN, KRAS, PIK3CA, IGFR-1. Immunohistochemistry of the same biomarkers.

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

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Observation		Breast cancer patients treated with Herceptin-based therapy	Genetic: Gene mutation analyses and FISH

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gene mutation analyses and FISH	Genetic	FISH and mutation analyses of multiple genes	Observation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Association of a specific biomarker with response to Herceptin-based therapy		Response after two months of treatment

Secondary Outcomes

Measure	Description	Time Frame
Association of a specific biomarker with time to progression survival and patient's characteristics		At the end of enrollment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hystological diagnosis of breast cancer
Availability of tumor tissue
Availability to assess the response to Trastuzumab according to RECIST criteria
Availability of clinical data

Exclusion Criteria:

Unavailability of tumor tissue
Impossibility to assess the response to Trastuzumab according to RECIST criteria

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

Breast cancer patients treated with Herceptin-based therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
C564369	Lethal Congenital Contracture Syndrome 2

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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

Browse Leaves

Not provided

Browse Branches

Not provided