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Trial record 1 of 1 for:    NCT00353483
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Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells

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ClinicalTrials.gov Identifier: NCT00353483
Recruitment Status : Recruiting
First Posted : July 18, 2006
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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

Condition or disease Intervention/treatment
Breast Neoplasms Procedure: Peripheral blood draw Procedure: Breast tissue collection Procedure: Bone marrow biopsy

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
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
Actual Study Start Date : September 14, 2005
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
Tissue, blood, and bone marrow 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
  • An attempt to collect blood on all patients 1/year for 5 years from the time of enrollment
Procedure: Peripheral blood draw
Procedure: Breast tissue collection
Procedure: Bone marrow biopsy



Primary Outcome Measures :
  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 5-11 years. ]

Biospecimen Retention:   Samples With DNA
Breast cancer tissue, peripheral blood, and bone marrow


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen in clinic at Washington University School of Medicine.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00353483


Contacts
Contact: Rebecca Aft, MD, PhD 314-747-0063 aftr@wustl.edu
Contact: Tracey Guthrie 314-747-4404 guthriet@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63119
Contact: Rebecca Aft, MD, PhD    314-747-0063    aftr@wustl.edu   
Contact: Tracey Guthrie    314-747-4404    guthriet@wustl.edu   
Principal Investigator: Rebecca Aft, MD, PhD         
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: Amy Cyr, 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         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Rebecca Aft, M.D., Ph.D. Washington University School of Medicine

Additional Information:
Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00353483     History of Changes
Other Study ID Numbers: 05-0648 / 201101961
First Posted: July 18, 2006    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Washington University School of Medicine:
Breast Cancer
Neoadjuvant

Additional relevant MeSH terms:
Breast Neoplasms
Bone Marrow Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hematologic Neoplasms
Bone Marrow Diseases
Hematologic Diseases