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 women who have undergone surgery for stage I, stage II, or stage IIIA breast cancer.

Condition	Treatment or Intervention
stage I breast cancer stage II breast cancer stage IIIA breast cancer	Procedure: conventional surgery  Procedure: diagnostic test  Procedure: immunohistochemistry  Procedure: surgery

Further Study Details: 

OBJECTIVES: Primary

• Determine the relative risk of death associated with the presence of tumor cells in the bone marrow of women with stage I, II, or IIIA breast cancer undergoing surgery and bone marrow analysis using multicolor fluorescence immunocytochemistry and bright field immunocytochemistry.

Secondary

• 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 at 3-4 weeks and then annually for 10 years.

PROJECTED ACCRUAL: A total of 1,634 patients will be accrued for this study within 3 years.

Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of invasive adenocarcinoma of the breast by 1 of the following methods:
• Core needle or excisional biopsy
• Fine needle aspiration AND clinical breast examination AND mammogram or ultrasound examination
• Clinical stage T1-3, N0-1, M0 disease
• Physical examination and bilateral mammogram within the past 6 months
• Operable by lumpectomy or mastectomy
• No prior breast malignancy, including ductal carcinoma
• (DCIS)
• Prior lobular carcinoma allowed
• No bilateral malignancy (including DCIS)
• No mass or imaging abnormality in the contralateral breast or axilla that is suspicious for malignancy unless proven to be nonmalignant by biopsy
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS: Age

• Any age

Sex

• Female

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• At least 10 years

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• No other malignancy within the past 5 years except carcinoma of the cervix, melanoma , carcinoma of the colon, or basal cell or squamous cell skin cancer
• No psychiatric or addictive disorder that would preclude giving informed consent

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• No preoperative chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• No prior radiotherapy for breast cancer

Surgery

• Not specified

Other

• No prior systemic therapy for breast cancer

Study chairs or principal investigators

David N. Krag, MD, FACS,  Study Chair,  Vermont Cancer Center at University of Vermont   

Study ID Numbers:  CDR0000378201; NSABP-BP-59; NCT00089323
Record last reviewed:  July 2004
Last Updated:  February 15, 2005
Record first received:  August 4, 2004
ClinicalTrials.gov Identifier:  NCT00089323
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08