NCT00353483 · Washington University School of Medicine
Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
What this study is about
The main purpose of this study is to compare genetic markers present on tumor cells before and after chemotherapy.
View original scientific description
The main purpose of this study is to compare genetic markers present on tumor cells before and after chemotherapy.
Interventions
PROCEDURE
Peripheral blood draw
PROCEDURE
Breast tissue collection
PROCEDURE
Bone marrow biopsy
Primary outcome measures
Characterize tumor markers expressed by DTC which are present after systemic therapy
Time frame: Approximately 6 years
Compare the expression of these markers to that on DTC detected prior to systemic therapy
Time frame: 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.
Time frame: 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.
Time frame: Approximately 6 years.
To xenograft tumor cells into mice for further genetic and phenotypic characterization.
Time frame: Approximately 6 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- St Louis, Missouri
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 28, 2025 · Source of record for eligibility and locations