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

March 15, 2024 updated by: Washington University School of Medicine
The main purpose of this study is to compare genetic markers present on tumor cells before and after chemotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Rebecca Aft, MD, PhD
  • Phone Number: 314-747-0063
  • Email: aftr@wustl.edu

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63119
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Sub-Investigator:
          • Haeseong Park, MD
        • Contact:
          • Rebecca Aft, MD, PhD
          • Phone Number: 314-747-0063
          • Email: aftr@wustl.edu
        • Sub-Investigator:
          • Mark Watson, MD, PhD
        • Sub-Investigator:
          • William Gillanders, MD
        • Sub-Investigator:
          • Timothy Eberlein, MD
        • Sub-Investigator:
          • Katherine Weilbaecher, MD
        • Sub-Investigator:
          • Michael Naughton, MD
        • Sub-Investigator:
          • Shunqiang Li, MD
        • Sub-Investigator:
          • Julie Margenthaler, MD
        • Sub-Investigator:
          • Cynthia Ma, MD
        • Sub-Investigator:
          • Katherine Glover-Collins, MD, PhD
        • Sub-Investigator:
          • Caron Rigden, MD
        • Sub-Investigator:
          • Rama Suresh, MD
        • Sub-Investigator:
          • Gregory Longmore, MD
        • Sub-Investigator:
          • Ashley Frith, MD
        • Sub-Investigator:
          • Foluso Ademuyiwa, MD
        • Sub-Investigator:
          • Peter Oppelt, MD
        • Sub-Investigator:
          • Ron Bose, MD, PhD
        • Sub-Investigator:
          • Leonel Hernandez Aya, MD
        • Sub-Investigator:
          • Mathew Cherian, MD
        • Sub-Investigator:
          • Lindsay Peterson, MD
        • Sub-Investigator:
          • Cara Cipriano, MD
        • Principal Investigator:
          • Rebecca Aft, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients seen in clinic at Washington University School of Medicine.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Procedure: Bone marrow biopsy
Procedure: Peripheral blood draw
Procedure: Breast tissue collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Characterize tumor markers expressed by DTC which are present after systemic therapy
Time Frame: Approximately 6 years
Approximately 6 years
Compare the expression of these markers to that on DTC detected prior to systemic therapy
Time Frame: Approximately 6 years
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
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.
Approximately 6 years.
To xenograft tumor cells into mice for further genetic and phenotypic characterization.
Time Frame: Approximately 6 years
Approximately 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Investigators

  • Principal Investigator: Rebecca Aft, M.D., Ph.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2005

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

July 17, 2006

First Submitted That Met QC Criteria

July 17, 2006

First Posted (Estimated)

July 18, 2006

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-0648 / 201101961

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Neoplasms

Clinical Trials on Bone marrow biopsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe