Effect of Chemotherapy Administered Before Surgery on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells - Full Text View

Sponsored by:	Washington University School of Medicine
Information provided by:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT00353483

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: Biopsies for tissue and blood collection

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Effect of Neoadjuvant Chemotherapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

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 3 years ] [ Designated as safety issue: No ]
Compare the expression of these markers to that on DTC detected prior to chemotherapy. [ Time Frame: Approximately 3 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 3 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 3 years. ] [ Designated as safety issue: No ]
To xenograft tumor cells into mice for further genetic and phenotypic characterization. [ Time Frame: Approximately 5-8 years. ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	November 2005
Estimated Study Completion Date:	August 2013
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Breast cancer tissue, peripheral blood, and bone marrow collection.	Procedure: Biopsies for tissue and blood collection Breast cancer tissue, peripheral blood, and bone marrow will be collected at the following times: Initial surgery Definitive Cancer surgery At one year, when port is removed If/when metastatic disease develops in accessible sites All patients regardless of disease status will undergo blood collection once a year for five years from the time of enrollment.

Arms

Assigned Interventions

1

Breast cancer tissue, peripheral blood, and bone marrow collection.

Procedure: Biopsies for tissue and blood collection

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

Initial surgery
Definitive Cancer surgery
At one year, when port is removed
If/when metastatic disease develops in accessible sites

All patients regardless of disease status will undergo blood collection once a year for five years from the time of enrollment.

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 or III breast cancer who will undergo neoadjuvant chemotherapy (chemotherapy prior to surgery)
Must not have known metastatic disease
Must be greater than 18 years of age
If female, must not be pregnant

Exclusion Criteria:

Pregnant, if female
Less than or equal to 18 years of age

Contacts and Locations

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

Contacts

Contact: Melissa Swank	314-747-5543	swankm@ccadmin.wustl.edu
Contact: Susan Fox	314-747-9209	foxs@ccadmin.wustl.edu

Locations

United States, Missouri
Washington University School of Medicine	Recruiting
St. Louis, Missouri, United States, 63119
Contact: Susan Fox 314-747-9209 foxs@ccadmin.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: Simon Powell, 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

Publications:

Diel IJ, Cote RJ. Bone marrow and lymph node assessment for minimal residual disease in patients with breast cancer. Cancer Treat Rev. 2000 Feb;26(1):53-65. Review.

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.

Braun S, Naume B. Circulating and disseminated tumor cells. J Clin Oncol. 2005 Mar 10;23(8):1623-6. Review. No abstract available.

Janni W, Rack B, Schindlbeck C, Strobl B, Rjosk D, Braun S, Sommer H, Pantel K, Gerber B, Friese K. The persistence of isolated tumor cells in bone marrow from patients with breast carcinoma predicts an increased risk for recurrence. Cancer. 2005 Mar 1;103(5):884-91.

Klein CA, Blankenstein TJ, Schmidt-Kittler O, Petronio M, Polzer B, Stoecklein NH, Riethmüller G. Genetic heterogeneity of single disseminated tumour cells in minimal residual cancer. Lancet. 2002 Aug 31;360(9334):683-9.

Choesmel V, Pierga JY, Nos C, Vincent-Salomon A, Sigal-Zafrani B, Thiery JP, Blin N. Enrichment methods to detect bone marrow micrometastases in breast carcinoma patients: clinical relevance. Breast Cancer Res. 2004;6(5):R556-70. Epub 2004 Jul 29.

Responsible Party:	Washington University School of Medicine ( Rebecca Aft, MD, PhD )
Study ID Numbers:	05-0648
Study First Received:	July 17, 2006
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00353483 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

Breast Cancer
Neoadjuvant

Study placed in the following topic categories:

Hematologic Neoplasms
Skin Diseases
Hematologic Diseases
Bone Marrow Neoplasms

Breast Neoplasms
Bone Marrow Diseases
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Hematologic Neoplasms
Skin Diseases
Hematologic Diseases

Bone Marrow Neoplasms
Breast Neoplasms
Bone Marrow Diseases
Breast Diseases

ClinicalTrials.gov processed this record on September 03, 2009