Breast Cancer Clinical Trial

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

Summary

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.

View Full Description

Full Description

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.

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

1630

Study ID:

NCT00089323

Recruitment Status:

Completed

Sponsor:

NSABP Foundation Inc

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 46 Locations for this study

See Locations Near You

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Tunnell Cancer Center at Beebe Medical Center
Lewes Delaware, 19958, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
Morton Plant Hospital
Clearwater Florida, 33756, United States
St. Vincent's Medical Center
Jacksonville Florida, 32204, United States
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland Florida, 33805, United States
Union Hospital of Cecil County
Elkton Maryland, 21921, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
St. Vincent Healthcare Cancer Care Services
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Montana, 59102, United States
Billings Clinic - Downtown
Billings Montana, 59107, United States
Bozeman Deaconess Cancer Center
Bozeman Montana, 59715, United States
St. James Healthcare Cancer Care
Butte Montana, 59701, United States
Great Falls Clinic - Main Facility
Great Falls Montana, 59405, United States
Sletten Cancer Institute at Benefis Healthcare
Great Falls Montana, 59405, United States
Northern Montana Hospital
Havre Montana, 59501, United States
St. Peter's Hospital
Helena Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology at KRMC
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59807, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59807, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees New Jersey, 08043, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte North Carolina, 28232, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa Oklahoma, 74136, United States
Bryn Mawr Hospital
Bryn Mawr Pennsylvania, 19010, United States
Cancer Center of Paoli Memorial Hospital
Paoli Pennsylvania, 19301, United States
CCOP - Main Line Health
Wynnewood Pennsylvania, 19096, United States
Lankenau Cancer Center at Lankenau Hospital
Wynnewood Pennsylvania, 19096, United States
M. D. Anderson Cancer Center at University of Texas
Houston Texas, 77030, United States
American Fork Hospital
American Fork Utah, 84003, United States
Sandra L. Maxwell Cancer Center
Cedar City Utah, 84720, United States
Logan Regional Hospital
Logan Utah, 84321, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray Utah, 84157, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden Utah, 84403, United States
Utah Valley Regional Medical Center - Provo
Provo Utah, 84604, United States
Dixie Regional Medical Center - East Campus
Saint George Utah, 84770, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City Utah, 84106, United States
Huntsman Cancer Institute at University of Utah
Salt Lake City Utah, 84112, United States
LDS Hospital
Salt Lake City Utah, 84143, United States
Fletcher Allen Health Care - University Health Center Campus
Burlington Vermont, 05401, United States
United Hospital Center
Clarksburg West Virginia, 26301, United States
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown West Virginia, 26506, United States
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg West Virginia, 26102, United States
Rocky Mountain Oncology
Casper Wyoming, 82609, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan Wyoming, 82801, United States
Hopital Notre-Dame du CHUM
Montreal Quebec, H2L 4, Canada
CHUM - Hotel Dieu Hospital
Montreal Quebec, H2W 1, Canada
CHUM - Hopital Saint-Luc
Montreal Quebec, H2X 3, Canada
Hopital du Saint-Sacrement - Quebec
Quebec City Quebec, G1S 4, Canada

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

1630

Study ID:

NCT00089323

Recruitment Status:

Completed

Sponsor:


NSABP Foundation Inc

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider