Comparing tumor markers in breast cancer patients before and after chemotherapy
Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
This study is trying to see if certain tumor markers in breast cancer patients can help predict how well they respond to chemotherapy and if they might have a higher chance of the cancer coming back.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT00353483 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze genetic markers on tumor cells in breast cancer patients before and after they undergo systemic therapy. The researchers hypothesize that certain disseminated tumor cells (DTC) that persist after treatment may indicate a poor response to therapy and correlate with worse clinical outcomes. The study will involve characterizing these tumor markers, comparing their expression pre- and post-therapy, and correlating them with patient outcomes to identify predictive markers for disease recurrence. Additionally, purified DTC will be isolated for further molecular analysis.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with clinical stage II, III, or IV breast cancer who are planning to undergo neoadjuvant or adjuvant systemic therapy.
Not a fit: Patients who have not been diagnosed with breast cancer or those with early-stage disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification of breast cancer patients at high risk for disease recurrence, allowing for more tailored treatment approaches.
How similar studies have performed: Other studies have explored the role of circulating tumor cells in breast cancer, showing promise in identifying treatment resistance, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Rebecca Aft, M.D., Ph.D. — Washington University School of Medicine
- Study coordinator: Rebecca Aft, MD, PhD
- Email: aftr@wustl.edu
- Phone: 314-747-0063
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.