Know Cancer

forgot password

Bone Marrow Analysis In Early-Stage Breast Cancer

18 Years
Open (Enrolling)
Breast Cancer

Thank you

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



CCOP - Christiana Care Health Services Wilmington, Delaware  19899
Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa, Oklahoma  74136
CCOP - Montana Cancer Consortium Billings, Montana  59101
LDS Hospital Salt Lake City, Utah  84143
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
Fletcher Allen Health Care - University Health Center Campus Burlington, Vermont  05401
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Blumenthal Cancer Center at Carolinas Medical Center Charlotte, North Carolina  28232-2861
Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096
Mary Babb Randolph Cancer Center at West Virginia University Hospitals Morgantown, West Virginia  26506
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Peter's Hospital Helena, Montana  59601
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
M. D. Anderson Cancer Center at University of Texas Houston, Texas  77030-4009
Huntsman Cancer Institute at University of Utah Salt Lake City, Utah  84112
Lakeland Regional Cancer Center at Lakeland Regional Medical Center Lakeland, Florida  33805
Cancer Institute of New Jersey at Cooper - Voorhees Voorhees, New Jersey  08043
Bryn Mawr Hospital Bryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau Hospital Wynnewood, Pennsylvania  19096
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Tunnell Cancer Center at Beebe Medical Center Lewes, Delaware  19958
Billings Clinic - Downtown Billings, Montana  59107-7000
Bozeman Deaconess Cancer Center Bozeman, Montana  59715
St. James Healthcare Cancer Care Butte, Montana  59701
Great Falls Clinic - Main Facility Great Falls, Montana  59405
Sletten Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Northern Montana Hospital Havre, Montana  59501
Kalispell Medical Oncology at KRMC Kalispell, Montana  59901
Sandra L. Maxwell Cancer Center Cedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center Murray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center Ogden, Utah  84403
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital Parkersburg, West Virginia  26102
Rocky Mountain Oncology Casper, Wyoming  82609
Morton Plant Hospital Clearwater, Florida  33756
Union Hospital of Cecil County Elkton MD, Maryland  21921
St. Vincent's Medical Center Jacksonville, Florida  32203
St. Vincent Healthcare Cancer Care Services Billings, Montana  59101
Cancer Center of Paoli Memorial Hospital Paoli, Pennsylvania  19301-1792
CCOP - Main Line Health Wynnewood, Pennsylvania  19096
United Hospital Center Clarksburg, West Virginia  26301