Determine Feasibility of Quantifying Apoptosis and Bcl-2 Expression in CTCs in Women With Metastatic Breast Cancer
This trial is active, not recruiting.
|Condition||metastatic breast cancer|
|Sponsor||University of Michigan Cancer Center|
|Start date||April 2005|
|End date||October 2008|
|Trial size||36 participants|
|Trial identifier||NCT00156273, HUM 45808 Legacy 2004-0703, UMCC 2003.075|
We are trying to develop better ways to detect when cancer therapies are working.
To determine the feasibility of detecting Bcl2 expression and apoptosis in CTCs
time frame: Prospective
Female participants at least 18 years old.
Inclusion Criteria: 1.Females at least 18 years of age 2 Diagnosis of metastatic breast cancer 3.ECOG Score of 0-2 4.Treating oncologist has decided to initiate any new systemic therapy with emphasis on recruiting patients commencing a taxane-based regimen. Taxine-based therapy may be docetaxel or paclitaxel, and it can be given on any schedule,including weekly or every 3 weeks. Other treatment can include non-taxane chemotherapy or trastuzumab-with or without other therapy. 5.Patient is willing to return for one or more additional ~18 mL blood draw (s) at 24-48-, and /or 72 hours and ~3-4 weeks after the initiation of therapy.At a minimum, patients must donate blood at baseline, one intermediate interval (24, 48, 72 hr) and at ~3-4 weeks 6.Signed Informed Consent Form Exclusion Criteria: Patient is unable and unwilling to provide a blood specimen at a minimum of one of the intermediate blood draw time points at 24, 48, or 72 hours -
|Official title||A Pilot Study to Determine the Feasibility of Quantifying Apoptosis and Bcl-2 Expression in Circulating Tumor Cells (CTCs) in Women Undergoing Treatment for Metastatic Breast Cancer|
|Principal investigator||Jeffrey Smerage, M.D., Ph.D.|
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