Clinical trial · Observational
Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
NCT00353483CI-TRIAL-00098034recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main purpose of this study is to compare genetic markers present on tumor cells before and after chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bone marrow biopsy | Procedure | — | UNRESOLVED |
| Breast tissue collection | Procedure | — | UNRESOLVED |
| Peripheral blood draw | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Tissue, blood, and bone marrow (optional) collection
- description
- * 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
- interventionNames
- Procedure: Peripheral blood draw
- Procedure: Breast tissue collection
- Procedure: Bone marrow biopsy
Primary outcomes (5)
- measure
- Characterize tumor markers expressed by DTC which are present after systemic therapy
- timeFrame
- Approximately 6 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (7)
- BACKGROUNDDiel 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. PMID 10660491
- BACKGROUNDBraun 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. PMID 10684910
- BACKGROUNDBraun 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. PMID 15755968
- BACKGROUNDJanni 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. PMID 15666325
- BACKGROUNDKlein 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. PMID 12241875
- BACKGROUNDChoesmel 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. PMID 15318937
- DERIVEDLesurf 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.