NCT00146029

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2005

Completed
Last Updated

March 26, 2008

Status Verified

March 1, 2008

First QC Date

September 1, 2005

Last Update Submit

March 24, 2008

Conditions

Metastatic Breast Cancer

Keywords

Patients who participated in UMCC 9900/9901 (Phase II Studies of Tailored-Dose Docetaxel in Metastatic Breast Cancer)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who participated on UMCC 9900/9901
  • Living patients must give written informed consent

You may not qualify if:

  • No tumor block tissue available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Anne F. Schott, M.D.

    University of Michigan Rogel Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 5, 2005

Last Updated

March 26, 2008

Record last verified: 2008-03

Locations

US(1)