- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00874146
Level of HER2-neu Gene Amplification an Response to Trastuzumab
September 1, 2010 updated by: Istituto Clinico Humanitas
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.
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Armando Santoro, MD
- Phone Number: 4080 ++39-028224
- Email: armando.santoro@humanitas.it
Study Contact Backup
- Name: Giuseppe Gullo, MD
- Phone Number: 4080 ++39-028224
- Email: giuseppe.gullo@humanitas.it
Study Locations
-
-
Milan
-
Rozzano, Milan, Italy, 20089
- Recruiting
- Istituto Clinco Humanitas
-
Contact:
- Giuseppe Gullo, MD
- Phone Number: 4080 +39028224
- Email: giuseppe.gullo@humanitas.it
-
Sub-Investigator:
- Giuseppe Gullo, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimen.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
HER2-positive advanced breast cancer
|
Dual color FISH test to assess ratio of HER2/neu amplification
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Association of tumor cytogenetic paremeters with TTP and OS.
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Association of cytogenetic parameters evalued by FISH test and patients' characteristics.
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (ACTUAL)
September 1, 2009
Study Completion (ANTICIPATED)
December 1, 2009
Study Registration Dates
First Submitted
March 26, 2009
First Submitted That Met QC Criteria
April 1, 2009
First Posted (ESTIMATE)
April 2, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
September 2, 2010
Last Update Submitted That Met QC Criteria
September 1, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONC/OSS-03-2008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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