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Level of HER2-neu Gene Amplification an Response to Trastuzumab

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Istituto Clinico Humanitas.
Recruitment status was  Recruiting
Information provided by:
Istituto Clinico Humanitas Identifier:
First received: March 26, 2009
Last updated: September 1, 2010
Last verified: September 2010
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: Observational Model: Cohort
Time Perspective: 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:

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
FISH test performed on paraffine embedded tumor sections.

Estimated Enrollment: 100
Study Start Date: March 2009
Estimated Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
HER2-positive advanced breast cancer
Genetic: Fluorescent in-situ hybridization (FISH)
Dual color FISH test to assess ratio of HER2/neu amplification


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00874146

Contact: Armando Santoro, MD ++39-028224 ext 4080
Contact: Giuseppe Gullo, MD ++39-028224 ext 4080

Istituto Clinco Humanitas Recruiting
Rozzano, Milan, Italy, 20089
Contact: Armando Santoro, MD    +39028224 ext 4080   
Contact: Giuseppe Gullo, MD    +39028224 ext 4080   
Sub-Investigator: Giuseppe Gullo, MD         
Sponsors and Collaborators
Istituto Clinico Humanitas
Principal Investigator: Armando Santoro, MD Istituto Clinico Humanitas
  More Information

Responsible Party: Armando Santoro, MD, Istituto Clinico Humanitas Identifier: NCT00874146     History of Changes
Other Study ID Numbers: ONC/OSS-03-2008 
Study First Received: March 26, 2009
Last Updated: September 1, 2010
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents processed this record on October 25, 2016