Breast Cancer Clinical Trial

Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells

Summary

The main purpose of this study is to compare genetic markers present on tumor cells before and after chemotherapy.

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Full Description

In this study, the investigators propose that persistent disseminated tumor cells (DTC) present after systemic therapy represent a unique subpopulation of all DTC, are predictors of a poor response to systemic therapy and correlate with poor clinical outcome. The investigators hypothesize that systemic therapy-resistant DTC can be identified by their expression of a unique constellation of tumor marker proteins which may be similar to those expressed by breast cancer stem cells. In this research, the investigators' specific aims are : 1) to characterize tumor markers expressed by DTC which are present after systemic therapy, 2) to compare the expression of these markers to that on DTC detected prior to systemic therapy, 3) to correlate expression of the defined tumor markers on DTC with clinical outcome of breast cancer patients to identify those markers that are predictive of disease recurrence, 4) to utilize biomarkers identified in Specific Aims 1 and 2 to isolate purified DTC for further molecular analysis.

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Eligibility Criteria

Inclusion Criteria:

Recently diagnosed with clinical stage II, III, or IV breast cancer
Planning to undergo neoadjuvant or adjuvant systemic therapy; patients who have already completed neoadjuvant systemic therapy are also eligible
Must be >= 18 years of age
If female, must not be pregnant
Must not have Hepatitis B, C, or HIV
Must be willing and able to sign informed consent document

Study is for people with:

Breast Cancer

Estimated Enrollment:

300

Study ID:

NCT00353483

Recruitment Status:

Recruiting

Sponsor:

Washington University School of Medicine

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There is 1 Location for this study

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Washington University School of Medicine
Saint Louis Missouri, 63119, United States More Info
Rebecca Aft, MD, PhD
Contact
314-747-0063
[email protected]
Tracey Guthrie
Contact
314-747-4404
[email protected]
Rebecca Aft, MD, PhD
Principal Investigator
Mark Watson, MD, PhD
Sub-Investigator
William Gillanders, MD
Sub-Investigator
Timothy Eberlein, MD
Sub-Investigator
Katherine Weilbaecher, MD
Sub-Investigator
Michael Naughton, MD
Sub-Investigator
Shunqiang Li, MD
Sub-Investigator
Julie Margenthaler, MD
Sub-Investigator
Cynthia Ma, MD
Sub-Investigator
Katherine Glover-Collins, MD, PhD
Sub-Investigator
Caron Rigden, MD
Sub-Investigator
Rama Suresh, MD
Sub-Investigator
Gregory Longmore, MD
Sub-Investigator
Ashley Frith, MD
Sub-Investigator
Foluso Ademuyiwa, MD
Sub-Investigator
Peter Oppelt, MD
Sub-Investigator
Haeseong Park, MD
Sub-Investigator
Ron Bose, MD, PhD
Sub-Investigator
Leonel Hernandez Aya, MD
Sub-Investigator
Mathew Cherian, MD
Sub-Investigator
Lindsay Peterson, MD
Sub-Investigator
Cara Cipriano, MD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

300

Study ID:

NCT00353483

Recruitment Status:

Recruiting

Sponsor:


Washington University School of Medicine

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