Diagnostic Procedures in Detecting Tumor Cells in the Bone Marrow of Patients Undergoing Surgery for Stage I, Stage II, or Stage IIIA Breast Cancer

OBJECTIVES:

Primary

- 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.

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 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.

Inclusion criteria

- Histologic diagnosis of invasive adenocarcinoma of the breast diagnosed by core,
incisional, or excisional biopsy.

- All of the following staging criteria must be met: Primary tumor must be operable and
staged as cT1-3 by clinical evaluation. Ipsilateral nodes must be cN0-1 by clinical
evaluation. No evidence of metastatic disease (M0).

Exclusion criteria:

- Patients with any history of breast malignancy including DCIS (patients with a history
of Lobular Carcinoma in Situ (LCIS) are eligible).

- Treatment including radiation therapy, chemotherapy, and/or hormonal therapy
administered for the currently diagnosed breast cancer prior to study entry. The only
exception is hormonal therapy, which may have been given for up to a total of 28 days
after diagnosis and before study entry.

- Patients who will be receiving preoperative chemotherapy.

- Bilateral malignancy (including DCIS).

- Other non-breast malignancies unless the patient is considered disease-free for 5
years before study entry and is deemed by their physician to be at low risk for
recurrence. Patients with the following cancers are eligible if diagnosed and treated
within the past 5 years: carcinoma in situ of the cervix, melanoma in situ, colon
carcinoma in situ, and basal cell and squamous cell carcinoma of the skin.