Breast Neoplasms
Conditions
Keywords
Breast Cancer, Neoadjuvant
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.
Interventions
Sponsors
Washington University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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. |
| To xenograft tumor cells into mice for further genetic and phenotypic characterization. | Approximately 6 years |
Countries
United States
Contacts
Primary ContactRebecca Aft, MD, PhD
Outcome results
None listed