Recruiting

Genetic Markers

Sponsor:

Washington University School of Medicine

Code:

NCT00353483

Conditions

Breast Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Peripheral blood draw

Breast tissue collection

Bone marrow biopsy

Study Details

Brief summary:

The main purpose of this study is to compare genetic markers present on tumor cells before and after chemotherapy.

Conditions

Breast Neoplasms

Study ID

NCT00353483

Start date

Sep 14, 2005

Status verified date

Nov, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Tissue, blood, and bone marrow (optional) collection

  • Undergo neoadjuvant systemic therapy

  • initial surgery for sentinel lymph node biopsy/portacath placement
  • definitive cancer surgery (if applicable)
  • when portacath is removed (1 year, if available)
  • if metastatic disease develops or is present in accessible sites, a sample may be collected at the time of specimen collection for diagnosis
  • Undergo Adjuvant Systemic Therapy

  • initial surgery for a sentinel lymph node biopsy/portacath placement
  • when portacath is removed (1 year, if available)
  • If metastatic disease develops or is present in accessible sites, a sample may be collected at the time of specimen collection for diagnosis.
  • Undergone neoadjuvant systemic therapy

  • during definitive cancer surgery/portacath removal (if available)
  • if metastatic disease develops or is present in accessible sites, a sample may be collected at the time of specimen collection for diagnosis

Interventions

Peripheral blood draw

Breast tissue collection

Bone marrow biopsy

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Rebecca Aft, MD, PhD

314-747-0063aftr@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63119

Contacts

Rebecca Aft, MD, PhD

314-747-0063aftr@wustl.edu

Tracey Guthrie

314-747-4404guthriet@wustl.edu

Principal Investigator:

Rebecca Aft, MD, PhD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Nov 28, 2025

Last verified

Nov, 2025

Keywords

  • Breast Cancer
  • Neoadjuvant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-11-28.