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Characterization of Circulating Tumor Cells (CTC) From Patients With Metastatic Breast Cancer Using the CTC-Endocrine Therapy Index

NCT01701050 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 121

Last updated 2017-03-08

No results posted yet for this study

Summary

Utilizing CellSearch® technology, the ability to both enumerate and reliably and reproducibly characterize circulating tumor cells (CTC) for tumor markers that predict endocrine sensitivity (estrogen receptor \[ER\] and Bcl-2) and resistance (HER2 and Ki67) has been demonstrated. An algorithm for a CTC-Endocrine Therapy Index (CTC-ETI) has been constructed that can be calculated for each patient using the CTC enumeration and marker results. The primary goal of this study is to determine a CTC-ETI in ER positive, HER2 negative metastatic breast cancer patients before the initiation of a new endocrine therapy for the identification of patients that will progress rapidly.

Conditions

Interventions

OTHER

Blood collection

Patients will have blood drawn for circulating tumor cell (CTC) endocrine therapy index (CTC-ETI) calculation at baseline (within 30 days prior to the initiation of endocrine therapy) and then subsequently 1, 2, 3 and up 12 months after the initiation of therapy, or at the time of disease progression, whichever occurs first.

Sponsors & Collaborators

  • Janssen Diagnostics, LLC

    lead INDUSTRY

Principal Investigators

  • Daniel F Hayes, M.D. · University of Michigan Rogel Cancer Center

  • Costanza Paoletti, M.D. · University of Michigan Rogel Cancer Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-01
Primary Completion
2016-11-10
Completion
2016-11-10

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01701050 on ClinicalTrials.gov