Observational Study of Breast Cancer Markers After Systemic Therapy

This observational study is looking at breast cancer cells to understand how they change after treatments like chemotherapy. Researchers want to identify specific markers on these cells that might predict if the cancer will return. You could be eligible if you've recently been diagnosed with stage II, III, or IV breast cancer and are planning to receive or have already completed systemic therapy (like chemotherapy). The study involves collecting blood, breast tissue, and bone marrow samples. The main goal is to compare markers on cancer cells before and after treatment, and see how these markers relate to your long-term health outcomes. This study is currently unclear about its recruitment status and plans to include about 300 participants.

Study design
This is an observational study, meaning researchers will collect information without giving new treatments. It plans to include about 300 participants.
What's involved
You would undergo procedures like peripheral blood draws, breast tissue collection, and bone marrow biopsies. These procedures help researchers collect samples for analysis.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow up with participants for approximately 6 years to correlate marker expression with clinical outcomes.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00353483

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

Recruiting
Not specifiedAges 18+Observational
Washington University School of Medicine
~300 participants
Updated 2025-11-28 on ClinicalTrials.gov
What's tested:Peripheral blood drawBreast tissue collectionBone marrow biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Characterize tumor markers expressed by DTC which are present after systemic therapy
Measured over Approximately 6 years
+4 more outcomes measured
Breast Neoplasms
1 sites across 1 states
Missouri1
  • Rebecca Aft, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

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Eligibility criteria

Inclusion

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
  • Characterize tumor markers expressed by DTC which are present after systemic therapyApproximately 6 years
  • Compare the expression of these markers to that on DTC detected prior to systemic therapyApproximately 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