Determine Feasibility of Quantifying Apoptosis and Bcl-2 Expression in CTCs in Women With Metastatic Breast Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 7, 2005

Last Updated Date

February 13, 2009

Start Date ^†

April 2005

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00156273 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Determine Feasibility of Quantifying Apoptosis and Bcl-2 Expression in CTCs in Women With Metastatic Breast Cancer

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

Brief Summary

We are trying to develop better ways to detect when cancer therapies are working.

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Other, Prospective

Condition ^†

Metastatic Breast Cancer

Intervention ^†

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Estimated Enrollment ^†

Estimated Completion Date

December 2012

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

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 -

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00156273

Responsible Party

Cancer Answer Line, U of M

Secondary IDs ^††

IRB 2004-0703

Study Sponsor ^†

University of Michigan Cancer Center

Collaborators ^††

Investigators ^†

Principal Investigator:

Jeffrey Smerage, M.D., Ph.D.

University of Michigan Cancer Center

Information Provided By

University of Michigan Cancer Center

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.