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

Recruiting

• Conditions: Breast Neoplasms

• Registration Number: NCT00353483
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2005-09-14
• Study First Submitted: 2006-07-17
• Study First Submitted QC: 2006-07-17
• Study First Posted: 2006-07-18
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterize tumor markers expressed by DTC which are present after systemic therapy	Approximately 6 years
Compare the expression of these markers to that on DTC detected prior to systemic therapy	Approximately 6 years
To xenograft tumor cells into mice for further genetic and phenotypic characterization.	Approximately 6 years
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
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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States