Recruiting
Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
The main purpose of this study is to compare genetic markers present on tumor cells before and after chemotherapy.
ClinicalTrials.gov IDNCT00353483
PhaseNot Applicable
Enrollment300
SponsorWashington University School of Medicine
Age18 Years and older
SexALL
Conditions studied
Breast Neoplasms
About this study
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 outcomes
- 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)
Eligibility information
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
Study locations
- Washington University School of Medicine, St Louis, Missouri 63119 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-05.