Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
NCT ID: NCT00353483
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2005-09-14
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Peripheral blood draw
Breast tissue collection
Bone marrow biopsy
Interventions
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Peripheral blood draw
Breast tissue collection
Bone marrow biopsy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Rebecca Aft, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Diel IJ, Cote RJ. Bone marrow and lymph node assessment for minimal residual disease in patients with breast cancer. Cancer Treat Rev. 2000 Feb;26(1):53-65. doi: 10.1053/ctrv.1999.0150.
Braun S, Pantel K, Muller P, Janni W, Hepp F, Kentenich CR, Gastroph S, Wischnik A, Dimpfl T, Kindermann G, Riethmuller G, Schlimok G. Cytokeratin-positive cells in the bone marrow and survival of patients with stage I, II, or III breast cancer. N Engl J Med. 2000 Feb 24;342(8):525-33. doi: 10.1056/NEJM200002243420801.
Braun S, Naume B. Circulating and disseminated tumor cells. J Clin Oncol. 2005 Mar 10;23(8):1623-6. doi: 10.1200/JCO.2005.10.073. No abstract available.
Janni W, Rack B, Schindlbeck C, Strobl B, Rjosk D, Braun S, Sommer H, Pantel K, Gerber B, Friese K. The persistence of isolated tumor cells in bone marrow from patients with breast carcinoma predicts an increased risk for recurrence. Cancer. 2005 Mar 1;103(5):884-91. doi: 10.1002/cncr.20834.
Klein CA, Blankenstein TJ, Schmidt-Kittler O, Petronio M, Polzer B, Stoecklein NH, Riethmuller G. Genetic heterogeneity of single disseminated tumour cells in minimal residual cancer. Lancet. 2002 Aug 31;360(9334):683-9. doi: 10.1016/S0140-6736(02)09838-0.
Choesmel V, Pierga JY, Nos C, Vincent-Salomon A, Sigal-Zafrani B, Thiery JP, Blin N. Enrichment methods to detect bone marrow micrometastases in breast carcinoma patients: clinical relevance. Breast Cancer Res. 2004;6(5):R556-70. doi: 10.1186/bcr898. Epub 2004 Jul 29.
Lesurf R, Griffith OL, Griffith M, Hundal J, Trani L, Watson MA, Aft R, Ellis MJ, Ota D, Suman VJ, Meric-Bernstam F, Leitch AM, Boughey JC, Unzeitig G, Buzdar AU, Hunt KK, Mardis ER. Genomic characterization of HER2-positive breast cancer and response to neoadjuvant trastuzumab and chemotherapy-results from the ACOSOG Z1041 (Alliance) trial. Ann Oncol. 2017 May 1;28(5):1070-1077. doi: 10.1093/annonc/mdx048.
Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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05-0648 / 201101961
Identifier Type: -
Identifier Source: org_study_id
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