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Effect of Neoadjuvant Chemotherapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Neoplasms

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Trial Information

Effect of Neoadjuvant Chemotherapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells


In this study, we propose that persistent disseminated tumor cells (DTC) present after
chemotherapy represent a unique subpopulation of all DTC, are predictors of a poor response
to chemotherapy, and correlate with poor clinical outcome. We hypothesize that
chemotherapy-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, our specific aims are : 1) to characterize tumor markers expressed
by DTC which are present after chemotherapy, 2) to compare the expression of these markers
to that on DTC detected prior to chemotherapy, 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.


Inclusion Criteria:



- Must be newly diagnosed with clinical stage II, III, or IV breast cancer who will
undergo neoadjuvant chemotherapy (chemotherapy prior to surgery)

- Must >= 18 years of age

- If female, must not be pregnant

- Must be willing and able to sign informed consent document

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Characterize tumor markers expressed by DTC which are present after chemotherapy.

Outcome Time Frame:

Approximately 6 years

Safety Issue:

No

Principal Investigator

Rebecca Aft, M.D., Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

05-0648 / 201101961

NCT ID:

NCT00353483

Start Date:

September 2005

Completion Date:

August 2016

Related Keywords:

  • Breast Neoplasms
  • Breast Cancer
  • Neoadjuvant
  • Breast Neoplasms
  • Neoplasms
  • Bone Marrow Neoplasms

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110