Diagnostic Procedures in Detecting Tumor Cells in the Bone Marrow of Patients Undergoing Surgery for Stage I, Stage II, or Stage IIIA Breast Cancer
RATIONALE: Diagnostic procedures that detect tumor cells in the bone marrow may help doctors predict disease recurrence and plan more effective treatment.
PURPOSE: This clinical trial is studying how well diagnostic procedures work in detecting tumor cells in the bone marrow of patients who have undergone surgery for stage I, stage II, or stage IIIA breast cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Bone Marrow Analysis In Early-Stage Breast Cancer|
- Overall survival [ Time Frame: From time of randomization to death from any cause through 10 years. ] [ Designated as safety issue: No ]
- Tumor cell presence as measured by bright-field and multicolor fluorescence immunocytochemical methods [ Time Frame: As detected at time of analysis. ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
- Determine the relative risk of death associated with the presence of tumor cells in the bone marrow of patients with stage I, II, or IIIA breast cancer undergoing surgery and bone marrow analysis using multicolor fluorescence immunocytochemistry and bright field immunocytochemistry.
- Compare multicolor fluorescence immunocytochemistry vs bright field immunocytochemistry in the detection of bone marrow micrometastases in these patients.
OUTLINE: This is a multicenter study.
Patients undergo bone marrow aspiration during surgical resection of the primary tumor. Bone marrow cells and tumor samples are analyzed using bright field immunocytochemistry and multicolor fluorescence immunocytochemistry.
Patients are followed every 12 months for up to 10 years.
PROJECTED ACCRUAL: A total of 1,634 patients will be accrued for this study within 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00089323
Show 53 Study Locations
|Principal Investigator:||Norman Wolmark, MD||NSABP Foundation Inc|