Metastatic Breast CancerNCT00146029
Companion Pharmacogenetic Study to UMCC 9900/9901
An observational study of Metastatic Breast Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial summary
The purpose is to examine the original breast tumor material to see how much of a metabolizing enzyme (CYP3A4) is present in tumor material. The researchers want to see if this is in any way associated with how the patient responded to docetaxel. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who participated on UMCC 9900/9901
- Living patients must give written informed consent
Who cannot join
- No tumor block tissue available
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
About this study
The purpose is to examine the original breast tumor material to see how much of a metabolizing enzyme (CYP3A4) is present in tumor material. The researchers want to see if this is in any way associated with how the patient responded to docetaxel. They also want to examine the genes in the tumor that are responsible for the production of CYP metabolizing enzymes, to see if they are normal or if they have polymorphisms, or change compared to 'normal' CYP metabolizing enzymes.
- Conditions
- Metastatic Breast Cancer
- Keywords
- Patients who participated in UMCC 9900/9901 (Phase II Studies of Tailored-Dose Docetaxel in Metastatic Breast Cancer)
- 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 posted5 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Anne F. Schott, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146029
- Sponsor's protocol ID
- UMCC 3-27
- Status last verified
- Mar 2008
- First submitted
- 1 Sep 2005
- Last updated
- 26 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Companion Pharmacogenetic Study to UMCC 9900/9901
- ClinicalTrials.gov ID
- NCT00146029
- Acronym / sponsor ID
- UMCC 3-27
- Conditions
- Metastatic Breast Cancer
- Keywords
- Patients who participated in UMCC 9900/9901 (Phase II Studies of Tailored-Dose Docetaxel in Metastatic Breast Cancer)
- Study type
- Observational
- Recruitment status
- Terminated
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- First posted
- 5 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 is to examine the original breast tumor material to see how much of a metabolizing enzyme (CYP3A4) is present in tumor material. The researchers want to see if this is in any way associated with how the patient responded to docetaxel. They also want to examine the genes in the tumor that are responsible for the production of CYP metabolizing enzymes, to see if they are normal or if they have polymorphisms, or change compared to 'normal' CYP metabolizing enzymes.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who participated on UMCC 9900/9901
- Living patients must give written informed consent
Key exclusion criteria (1 listed)
- No tumor block tissue available
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 was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2008.
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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.
Anne F. Schott, M.D. principal investigator
University of Michigan Rogel Cancer Center
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 Metastatic Breast Cancer, run by University of Michigan Rogel Cancer Center at 1 site 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 2 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: stopped early, as of the sponsor's last update on 26 Mar 2008. 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 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 was stopped early. Results are not available in the source record.
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 26 Mar 2008.