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Bone Marrow Analysis In Early-Stage Breast Cancer

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Bone Marrow Analysis In Early-Stage Breast Cancer



- 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


- 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

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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Overall survival

Outcome Time Frame:

From time of randomization to death from any cause through 10 years.

Safety Issue:


Principal Investigator

Norman Wolmark, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Surgical Adjuvant Breast and Bowel Project (NSABP)


United States: Federal Government

Study ID:




Start Date:

January 2007

Completion Date:

April 2016

Related Keywords:

  • Breast Cancer
  • stage IA breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • male breast cancer
  • stage IB breast cancer
  • Breast Neoplasms



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