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Trial record 1 of 1 for:    NCT00353483
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Effect of Chemotherapy Administered Before Surgery on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells

This study is currently recruiting participants.
Verified May 2013 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00353483
First received: July 17, 2006
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention
Breast Neoplasms
 Procedure: Blood draw

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effect of Neoadjuvant Chemotherapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Characterize tumor markers expressed by DTC which are present after chemotherapy. [ Time Frame: Approximately 6 years ] [ Designated as safety issue: No ]
  • Compare the expression of these markers to that on DTC detected prior to chemotherapy. [ Time Frame: Approximately 6 years ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: Approximately 6 years ] [ Designated as safety issue: No ]
  • Compare the tumor markers present on DTC before and after chemotherapy with the tumor marker expression of the primary tumor and post-treatment tumor. [ Time Frame: Approximately 6 years. ] [ Designated as safety issue: No ]
  • To xenograft tumor cells into mice for further genetic and phenotypic characterization. [ Time Frame: Approximately 5-11 years. ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2005
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1

Breast cancer tissue, peripheral blood, and bone marrow will be collected at that following times:

  • at the time of initial surgery for a sentinel lymph node biopsy or portacath placement
  • during definitive cancer surgery (if surgery occurs)
  • at one year, when portacath is removed (if available)
  • if metastatic disease (nodules, pleural effusion, or other metastatic disease) develops or is present in accessible sites, a sample may be collected at the time of specimen collection for diagnosis

All patients will undergo blood collection once a year for 5 years from the time of enrollment

 Procedure: Blood draw

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00353483

Contacts
Contact: Farley Johnson, MA, BA, CCRP 314-747-9202 johnsonf@wudosis.wustl.edu
Contact: Kirsten Cady, BS, CCRP 314-362-7773 cadyk@wudosis.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63119
Contact: Farley Johnson, MA, BA, CCRP     314-747-9202     johnsonf@wudosis.wustl.edu    
Contact: Kirsten Cady, BS, CCRP     314-362-7773     cadyk@wudosis.wustl.edu    
Principal Investigator: Rebecca Aft, MD, PhD            
Sub-Investigator: Mark Watson, MD, PhD            
Sub-Investigator: Lourdes Ylagan, MD            
Sub-Investigator: Tim Fleming, PhD            
Sub-Investigator: William Gillanders, MD            
Sub-Investigator: Timothy Eberlein, MD            
Sub-Investigator: Matthew Ellis, MB, PhD            
Sub-Investigator: Katherine Weilbaecher, MD            
Sub-Investigator: Michael Naughton, MD            
Sub-Investigator: Loren Michel, MD            
Sub-Investigator: Shunqiang Li, MD            
Sub-Investigator: Julie Margenthaler, MD            
Sub-Investigator: Steven Sorscher, MD            
Sub-Investigator: Cynthia Ma, MD            
Sub-Investigator: Timothy Pluard, MD            
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Rebecca Aft, M.D., Ph.D. Washington University School of Medicine
  More Information

Additional Information:
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine  This link exits the ClinicalTrials.gov site

Publications:
Braun, S., Pantel, K., Muller, P., Janni, W., Hepp, F., Kentenich, C. R. M., Gastroph, S., Wischnik, A., Dimpfl, T., Kindermann, G., Riethmuller, G., and Schlimok, G. Cytoleratin-Positive Cells in the Bone Marrow and Surivial of Patients with Stage I, II, or III Breast Cancer. N Engl J Med, 342: 525-533, 2000.

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00353483     History of Changes
Other Study ID Numbers: 05-0648 / 201101961
Study First Received: July 17, 2006
Last Updated: May 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
Breast Cancer
Neoadjuvant

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Bone Marrow Neoplasms
Neoplasms by Site
Breast Diseases
 Skin Diseases
Hematologic Neoplasms
Bone Marrow Diseases
Hematologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013