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NCT Number: NCT00353483

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.

Recruiting

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63119, United States

Location status: Recruiting

Location contact

Ashley Frith, MD

SUB_INVESTIGATOR

Cara Cipriano, MD

SUB_INVESTIGATOR

Caron Rigden, MD

SUB_INVESTIGATOR

Cynthia Ma, MD

SUB_INVESTIGATOR

Foluso Ademuyiwa, MD

SUB_INVESTIGATOR

Gregory Longmore, MD

SUB_INVESTIGATOR

Haeseong Park, MD

SUB_INVESTIGATOR

Julie Margenthaler, MD

SUB_INVESTIGATOR

Katherine Glover-Collins, MD, PhD

SUB_INVESTIGATOR

Katherine Weilbaecher, MD

SUB_INVESTIGATOR

Leonel Hernandez Aya, MD

SUB_INVESTIGATOR

Lindsay Peterson, MD

SUB_INVESTIGATOR

Mark Watson, MD, PhD

SUB_INVESTIGATOR

Mathew Cherian, MD

SUB_INVESTIGATOR

Michael Naughton, MD

SUB_INVESTIGATOR

Peter Oppelt, MD

SUB_INVESTIGATOR

Rama Suresh, MD

SUB_INVESTIGATOR

Rebecca Aft, MD, PhD

CONTACT

[email protected]

314-747-0063

Rebecca Aft, MD, PhD

PRINCIPAL_INVESTIGATOR

Ron Bose, MD, PhD

SUB_INVESTIGATOR

Shunqiang Li, MD

SUB_INVESTIGATOR

Timothy Eberlein, MD

SUB_INVESTIGATOR

Tracey Guthrie

CONTACT

[email protected]

314-747-4404

William Gillanders, MD

SUB_INVESTIGATOR

About this study

In this study, the investigators propose that persistent disseminated tumor cells (DTC) present after systemic therapy represent a unique subpopulation of all DTC, are predictors of a poor response to systemic therapy and correlate with poor clinical outcome. The investigators hypothesize that systemic therapy-resistant DTC can be identified by their expression of a unique constellation of tumor marker proteins which may be similar to those expressed by breast cancer stem cells. In this research, the investigators' specific aims are : 1) to characterize tumor markers expressed by DTC which are present after systemic therapy, 2) to compare the expression of these markers to that on DTC detected prior to systemic therapy, 3) to 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, 4) to utilize biomarkers identified in Specific Aims 1 and 2 to isolate purified DTC for further molecular analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peripheral blood draw

Procedure

Breast tissue collection

Procedure

Bone Marrow Biopsy

Procedure

Primary outcomes

  1. Characterize tumor markers expressed by DTC which are present after systemic therapy

    Time frame: Approximately 6 years

  2. Compare the expression of these markers to that on DTC detected prior to systemic therapy

    Time frame: Approximately 6 years

  3. 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

  4. 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.

  5. To xenograft tumor cells into mice for further genetic and phenotypic characterization.

    Time frame: Approximately 6 years

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca Aft, MD, PhD

CONTACT

[email protected]

314-747-0063

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Important dates

Study start
2005
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2006
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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