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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

To determine the feasibility of detecting Bcl2 expression and apoptosis in CTCs
time frame: Prospective

Eligibility Criteria

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 -

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Michigan Cancer Center.