Breast CancerNCT00153218
An Observational Study of Current Practice Pattern on the Treatment of Women With Metastatic Breast Cancer Whose Tumors Overexpress Her2neu
An observational study of Breast Cancer, run by Cancer Research Network at 2 sites in United States.
Trial summary
The purpose of this study is to observe clinical outcomes of metastatic breast cancer patients whose tumors overexpress the Her2neu protein and are being treated with trastuzumab (Herceptin)either alone or combination with chemotherapy or hormonal therapy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 94 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2004to not given
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Her-2-neu positive breast cancer patients
Who may be able to join
- patients must have metastatic breast cancer
- tumor must have been determined to be Her-2 positive 3+ by immunohistochemistry or gene-amplified by fluorescence-in-situ hybridization (FISH)
- must have received trastuzumab alone or in combination with chemotherapy or hormonal therapy
- must not have received trastuzumab in the adjuvant or neoadjuvant setting
- must have started trastuzumab treatment for metastatic disease any time between January 1996 to June 2003
Who cannot join
- patients who received trastuzumab prior to 1996
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pittsburgh Cancer Institute Magee-Womans Hospital
Pittsburgh, Pennsylvania, 15213
Cancer Research Network, Inc.
Plantation, Florida, 33324
About this study
The purpose of this study is to observe clinical outcomes of metastatic breast cancer patients whose tumors overexpress the Her2neu protein and are being treated with trastuzumab (Herceptin)either alone or combination with chemotherapy or hormonal therapy.
Read the detailed description
In clinical practice, patients with metastatic breast cancer are being treated either with trastuzumab alone or trastuzumab in combination with chemotherapy or hormonal therapy as it has shown to increase survival. There is currently minimal information as to how long trastuzumab should be given after disease progresses on trastuzumab. This study is a chart review of the above-mentioned population which will capture information such as;
- what chemo or hormonal therapies are chosen by clinicians for Her-2 positive metastatic patients to combine with trastuzumab
- what the number of treatment regimens are (chemo or hormonal) given with trastuzumab
- what the clinical outcome of patients treated is
- what happens to the patients cardiac status with long term administration of trastuzumab
- what treatment patterns exist in the management of central nervous system metastases
This study aims to generate a hypotheses that can be tested from the information collected after is has been analyzed to give clinicians further meaningful data to guide treatment decisions beyond treatment progression.
- Conditions
- Breast Cancer
- Keywords
- Metastatic Breast Cancer, Her2neu, trastuzumab
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Research Network
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Elizabeth Tan-Chiu, MD, Principal investigator, Cancer Reserach Network, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153218
- Sponsor's protocol ID
- H2933s
- Other IDs
- CRN006
- Status last verified
- Feb 2012
- First submitted
- 7 Sep 2005
- Last updated
- 14 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Current Practice Pattern on the Treatment of Women With Metastatic Breast Cancer Whose Tumors Overexpress Her2neu
- ClinicalTrials.gov ID
- NCT00153218
- Acronym / sponsor ID
- H2933s
- Conditions
- Breast Cancer
- Keywords
- Metastatic Breast Cancer, Her2neu, trastuzumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Cancer Research NetworkUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jun 2004
- First posted
- 12 Sep 2005 (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.
The purpose of this study is to observe clinical outcomes of metastatic breast cancer patients whose tumors overexpress the Her2neu protein and are being treated with trastuzumab (Herceptin)either alone or combination with chemotherapy or hormonal therapy.
Detailed description
In clinical practice, patients with metastatic breast cancer are being treated either with trastuzumab alone or trastuzumab in combination with chemotherapy or hormonal therapy as it has shown to increase survival. There is currently minimal information as to how long trastuzumab should be given after disease progresses on trastuzumab. This study is a chart review of the above-mentioned population which will capture information such as;
- what chemo or hormonal therapies are chosen by clinicians for Her-2 positive metastatic patients to combine with trastuzumab
- what the number of treatment regimens are (chemo or hormonal) given with trastuzumab
- what the clinical outcome of patients treated is
- what happens to the patients cardiac status with long term administration of trastuzumab
- what treatment patterns exist in the management of central nervous system metastases
This study aims to generate a hypotheses that can be tested from the information collected after is has been analyzed to give clinicians further meaningful data to guide treatment decisions beyond treatment progression.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Her-2-neu positive breast cancer patients
Key inclusion criteria (5 listed)
- patients must have metastatic breast cancer
- tumor must have been determined to be Her-2 positive 3+ by immunohistochemistry or gene-amplified by fluorescence-in-situ hybridization (FISH)
- must have received trastuzumab alone or in combination with chemotherapy or hormonal therapy
- must not have received trastuzumab in the adjuvant or neoadjuvant setting
- must have started trastuzumab treatment for metastatic disease any time between January 1996 to June 2003
Key exclusion criteria (1 listed)
- patients who received trastuzumab prior to 1996
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
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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.
Elizabeth Tan-Chiu, MD principal investigator
Cancer Reserach Network, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Cancer Research Network at 2 sites in United States.
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 5 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: finished, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 14 Feb 2012; AzTrials last refreshed its copy on 2 Nov 2026.