Advanced Breast CancerNCT00874146
Level of HER2-neu Gene Amplification an Response to Trastuzumab
An observational study of Advanced Breast Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Fluorescent in-situ hybridization (FISH)
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2009to Dec 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimen.
Who may be able to join
- HER2-positive breast cancer Trastuzumab-containing regimen delivered for advanced disease Tumor sample available at Pathology Archive
Who cannot join
- HER2-negative advanced breast cancer Pretreatment with trastuzumab
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Istituto Clinco Humanitas
Rozzano, Milan, 20089
Armando Santoro, MD, +39028224 ext. 4080, armando.santoro@humanitas.it
Giuseppe Gullo, MD, +39028224 ext. 4080, giuseppe.gullo@humanitas.it
About this study
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.
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.
- Conditions
- Advanced Breast Cancer
- Being tested
- Fluorescent in-situ hybridization (FISH)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescent in-situ hybridization (FISH)Genetic
Dual color FISH test to assess ratio of HER2/neu amplification
| Study group | Role | What they receive |
|---|---|---|
| 1 | HER2-positive advanced breast cancer Receives: Genetic: Fluorescent in-situ hybridization (FISH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of tumor cytogenetic paremeters with TTP and OS.
Measured: one year
Secondary outcomes (1)
Association of cytogenetic parameters evalued by FISH test and patients' characteristics.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionSep 2009
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Investigators
- Armando Santoro, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874146
- Sponsor's protocol ID
- ONC/OSS-03-2008
- Status last verified
- Sep 2010
- First submitted
- 26 Mar 2009
- Last updated
- 2 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00874146
- Acronym / sponsor ID
- ONC/OSS-03-2008
- Conditions
- Advanced Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (estimated)
- First posted
- 2 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Genetic: Fluorescent in-situ hybridization (FISH)HER2-positive advanced breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HER2-positive advanced breast cancer treated with trastuzumab-containing regimen.
Key inclusion criteria (1 listed)
- HER2-positive breast cancer Trastuzumab-containing regimen delivered for advanced disease Tumor sample available at Pathology Archive
Key exclusion criteria (1 listed)
- HER2-negative advanced breast cancer Pretreatment with trastuzumab
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorescent in-situ hybridization (FISH)Dual color FISH test to assess ratio of HER2/neu amplification | Genetic | 1 |
Primary outcome
Association of tumor cytogenetic paremeters with TTP and OS.
Time frame: one year
1 secondary outcome
Association of cytogenetic parameters evalued by FISH test and patients' characteristics.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armando Santoro, MD principal investigator
Istituto Clinico Humanitas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Breast Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Armando Santoro, MD (++39-028224 ext. 4080, armando.santoro@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of tumor cytogenetic paremeters with TTP and OS. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2010; AzTrials last refreshed its copy on 8 Nov 2026.