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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT00353483
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Peripheral blood draw — PROCEDURE
  • Breast tissue collection — PROCEDURE
  • Bone marrow biopsy — PROCEDURE

Study Details

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

Key Dates

Start date
Sep 14, 2005
Status verified
Nov 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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

Primary Outcome Measure

Characterize tumor markers expressed by DTC which are present after systemic therapy [ Time Frame: Approximately 6 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63119
Rebecca Aft, MD, PhD
314-747-0063
Tracey Guthrie
314-747-4404
Rebecca Aft, MD, PhD (PRINCIPAL_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)
Haeseong Park, 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 (SUB_INVESTIGATOR)

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