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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00353483
• Other study ID #: 05-0648 / 201101961
• Status: Recruiting
• Start date: September 14, 2005
• Est. completion date: August 31, 2025

Study information

• Verified date: March 2024
• Source: Washington University School of Medicine
• Contact: Rebecca Aft, MD, PhD
• Phone: 314-747-0063
• Email: aftr[@]wustl.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Neoplasms
• Breast Neoplasms

Intervention

Procedure:
• Peripheral blood draw

• Breast tissue collection

• Bone marrow biopsy

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

References & Publications (6)

Braun S, Naume B. Circulating and disseminated tumor cells. J Clin Oncol. 2005 Mar 10;23(8):1623-6. doi: 10.1200/JCO.2005.10.073. No abstract available. — View Citation

Braun S, Pantel K, Muller P, Janni W, Hepp F, Kentenich CR, Gastroph S, Wischnik A, Dimpfl T, Kindermann G, Riethmuller G, Schlimok G. Cytokeratin-positive cells in the bone marrow and survival of patients with stage I, II, or III breast cancer. N Engl J Med. 2000 Feb 24;342(8):525-33. doi: 10.1056/NEJM200002243420801. Erratum In: N Engl J Med 2000 Jul 27;343(4):308. — View Citation

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. doi: 10.1186/bcr898. Epub 2004 Jul 29. — View Citation

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. doi: 10.1053/ctrv.1999.0150. — View Citation

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. doi: 10.1002/cncr.20834. — View Citation

Klein CA, Blankenstein TJ, Schmidt-Kittler O, Petronio M, Polzer B, Stoecklein NH, Riethmuller G. Genetic heterogeneity of single disseminated tumour cells in minimal residual cancer. Lancet. 2002 Aug 31;360(9334):683-9. doi: 10.1016/S0140-6736(02)09838-0. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characterize tumor markers expressed by DTC which are present after systemic therapy		Approximately 6 years
Primary	Compare the expression of these markers to that on DTC detected prior to systemic therapy		Approximately 6 years
Primary	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.		Approximately 6 years
Primary	Compare the tumor markers present on DTC before and after chemotherapy with the tumor marker expression of the primary tumor and post-treatment tumor.		Approximately 6 years.
Primary	To xenograft tumor cells into mice for further genetic and phenotypic characterization.		Approximately 6 years

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine