Breast CancerNCT00105456
A Study of Patients With HER2-Positive Metastatic Breast Cancer
An observational study of Breast Cancer, run by Genentech, Inc..
Trial summary
This is a prospective observational cohort study designed to describe effectiveness and safety (treatment outcomes and clinically significant cardiac adverse events, respectively) in patients with HER2-positive metastatic breast cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Cancer
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to May 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients from managed care organizations, community physicians or practices, and academic centers.
Who may be able to join
- Signed Informed Consent document (unless the IRB has granted a waiver of consent)
- Signed Authorization for the Use and Disclosure of Health Information document
- HER2-positive breast cancer
- Initial diagnosis of metastatic (Stage IV) breast cancer within 6 months prior to enrollment
- Availability of cancer-specific historical data points in the patient's medical records
Who cannot join
- There are no exclusion criteria for participation in this trial
About this study
Official title: registHER: An Observational Cohort Study of Patients With HER2 Positive Metastatic Breast Cancer
This is a prospective observational cohort study designed to describe effectiveness and safety (treatment outcomes and clinically significant cardiac adverse events, respectively) in patients with HER2-positive metastatic breast cancer.
- Conditions
- Breast Cancer
- Keywords
- HER2-Positive Metastatic Breast Cancer, HER2
- 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 posted15 Mar 2005 (estimated)
- Study startMar 2003
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The 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
- Prospective
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Isaiah Dimery, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00105456
- Sponsor's protocol ID
- H2757n
- Status last verified
- May 2010
- First submitted
- 14 Mar 2005
- Last updated
- 6 May 2010
- Results posted
- No
Publications
Yardley DA, Tripathy D, Brufsky AM, Rugo HS, Kaufman PA, Mayer M, Magidson J, Yoo B, Quah C, Ulcickas Yood M. Long-term survivor characteristics in HER2-positive metastatic breast cancer from registHER. Br J Cancer. 2014 May 27;110(11):2756-64. doi: 10.1038/bjc.2014.174. Epub 2014 Apr 17.
PubMed 24743708
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- registHER: An Observational Cohort Study of Patients With HER2 Positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00105456
- Acronym / sponsor ID
- H2757n
- Conditions
- Breast Cancer
- Keywords
- HER2-Positive Metastatic Breast Cancer, HER2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2003
- Study completion
- May 2009 (actual)
- First posted
- 15 Mar 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.
This is a prospective observational cohort study designed to describe effectiveness and safety (treatment outcomes and clinically significant cardiac adverse events, respectively) in patients with HER2-positive metastatic breast cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients from managed care organizations, community physicians or practices, and academic centers.
Key inclusion criteria (5 listed)
- Signed Informed Consent document (unless the IRB has granted a waiver of consent)
- Signed Authorization for the Use and Disclosure of Health Information document
- HER2-positive breast cancer
- Initial diagnosis of metastatic (Stage IV) breast cancer within 6 months prior to enrollment
- Availability of cancer-specific historical data points in the patient's medical records
Key exclusion criteria (1 listed)
- There are no exclusion criteria for participation in this trial
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 6 May 2010.
- Derived from this study: PubMed 24743708Yardley DA, Tripathy D, Brufsky AM, Rugo HS, Kaufman PA, Mayer M, Magidson J, Yoo B, Quah C, Ulcickas Yood M. Long-term survivor characteristics in HER2-positive metastatic breast cancer from registHER. Br J Cancer. 2014 May 27;110(11):2756-64. doi: 10.1038/bjc.2014.174. Epub 2014 Apr 17.
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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.
Isaiah Dimery, M.D. study director
Genentech, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Genentech, Inc..
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 6 May 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
On the ClinicalTrials.gov record for NCT00105456, which also lists 1 linked publication.
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 6 May 2010.