Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
- Conditions
- Breast Neoplasms
- Interventions
- Procedure: Peripheral blood drawProcedure: Breast tissue collectionProcedure: Bone marrow biopsy
- Registration Number
- NCT00353483
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tissue, blood, and bone marrow (optional) collection Peripheral blood draw * 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 Tissue, blood, and bone marrow (optional) collection Breast tissue 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 Tissue, blood, and bone marrow (optional) collection Bone marrow biopsy * 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 Measures
Name Time Method 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. 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. Approximately 6 years. Characterize tumor markers expressed by DTC which are present after systemic therapy Approximately 6 years Compare the expression of these markers to that on DTC detected prior to systemic therapy Approximately 6 years To xenograft tumor cells into mice for further genetic and phenotypic characterization. Approximately 6 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States