Diagnostic Procedures in Detecting Tumor Cells in the Bone Marrow of Patients Undergoing Surgery for Stage I, Stage II, or Stage IIIA Breast Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 1: Bone Marrow Aspiration
|
Procedure: Bone Marrow Aspiration
|
Outcome Measures
Primary Outcome Measures
- Overall survival [From time of randomization to death from any cause through 10 years.]
Secondary Outcome Measures
- Tumor cell presence as measured by bright-field and multicolor fluorescence immunocytochemical methods [As detected at time of analysis.]
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
| 2 | Tunnell Cancer Center at Beebe Medical Center | Lewes | Delaware | United States | 19958 |
| 3 | CCOP - Christiana Care Health Services | Newark | Delaware | United States | 19713 |
| 4 | Morton Plant Hospital | Clearwater | Florida | United States | 33756 |
| 5 | St. Vincent's Medical Center | Jacksonville | Florida | United States | 32204 |
| 6 | Lakeland Regional Cancer Center at Lakeland Regional Medical Center | Lakeland | Florida | United States | 33805 |
| 7 | Union Hospital of Cecil County | Elkton | Maryland | United States | 21921 |
| 8 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
| 9 | Northern Rockies Radiation Oncology Center | Billings | Montana | United States | 59101 |
| 10 | St. Vincent Healthcare Cancer Care Services | Billings | Montana | United States | 59101 |
| 11 | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | United States | 59102 |
| 12 | Billings Clinic - Downtown | Billings | Montana | United States | 59107-7000 |
| 13 | Bozeman Deaconess Cancer Center | Bozeman | Montana | United States | 59715 |
| 14 | St. James Healthcare Cancer Care | Butte | Montana | United States | 59701 |
| 15 | Great Falls Clinic - Main Facility | Great Falls | Montana | United States | 59405 |
| 16 | Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana | United States | 59405 |
| 17 | Northern Montana Hospital | Havre | Montana | United States | 59501 |
| 18 | St. Peter's Hospital | Helena | Montana | United States | 59601 |
| 19 | Glacier Oncology, PLLC | Kalispell | Montana | United States | 59901 |
| 20 | Kalispell Medical Oncology at KRMC | Kalispell | Montana | United States | 59901 |
| 21 | Kalispell Regional Medical Center | Kalispell | Montana | United States | 59901 |
| 22 | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | United States | 59807-7877 |
| 23 | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | United States | 59807 |
| 24 | Cancer Institute of New Jersey at Cooper - Voorhees | Voorhees | New Jersey | United States | 08043 |
| 25 | Blumenthal Cancer Center at Carolinas Medical Center | Charlotte | North Carolina | United States | 28232-2861 |
| 26 | Wayne Memorial Hospital, Incorporated | Goldsboro | North Carolina | United States | 27534 |
| 27 | Wake Forest University Comprehensive Cancer Center | Winston-Salem | North Carolina | United States | 27157-1096 |
| 28 | Natalie Warren Bryant Cancer Center at St. Francis Hospital | Tulsa | Oklahoma | United States | 74136 |
| 29 | Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | United States | 19010 |
| 30 | Cancer Center of Paoli Memorial Hospital | Paoli | Pennsylvania | United States | 19301-1792 |
| 31 | CCOP - Main Line Health | Wynnewood | Pennsylvania | United States | 19096 |
| 32 | Lankenau Cancer Center at Lankenau Hospital | Wynnewood | Pennsylvania | United States | 19096 |
| 33 | M. D. Anderson Cancer Center at University of Texas | Houston | Texas | United States | 77030-4009 |
| 34 | American Fork Hospital | American Fork | Utah | United States | 84003 |
| 35 | Sandra L. Maxwell Cancer Center | Cedar City | Utah | United States | 84720 |
| 36 | Logan Regional Hospital | Logan | Utah | United States | 84321 |
| 37 | Jon and Karen Huntsman Cancer Center at Intermountain Medical Center | Murray | Utah | United States | 84157 |
| 38 | Val and Ann Browning Cancer Center at McKay-Dee Hospital Center | Ogden | Utah | United States | 84403 |
| 39 | Utah Valley Regional Medical Center - Provo | Provo | Utah | United States | 84604 |
| 40 | Dixie Regional Medical Center - East Campus | Saint George | Utah | United States | 84770 |
| 41 | Utah Cancer Specialists at UCS Cancer Center | Salt Lake City | Utah | United States | 84106 |
| 42 | Huntsman Cancer Institute at University of Utah | Salt Lake City | Utah | United States | 84112 |
| 43 | LDS Hospital | Salt Lake City | Utah | United States | 84143 |
| 44 | Fletcher Allen Health Care - University Health Center Campus | Burlington | Vermont | United States | 05401 |
| 45 | United Hospital Center | Clarksburg | West Virginia | United States | 26301 |
| 46 | Mary Babb Randolph Cancer Center at West Virginia University Hospitals | Morgantown | West Virginia | United States | 26506 |
| 47 | Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital | Parkersburg | West Virginia | United States | 26102 |
| 48 | Rocky Mountain Oncology | Casper | Wyoming | United States | 82609 |
| 49 | Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | United States | 82801 |
| 50 | Hopital Notre-Dame du CHUM | Montreal | Quebec | Canada | H2L 4M1 |
| 51 | CHUM - Hotel Dieu Hospital | Montreal | Quebec | Canada | H2W 1T8 |
| 52 | CHUM - Hopital Saint-Luc | Montreal | Quebec | Canada | H2X 3J4 |
| 53 | Hopital du Saint-Sacrement - Quebec | Quebec City | Quebec | Canada | G1S 4L8 |
Sponsors and Collaborators
- NSABP Foundation Inc
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Norman Wolmark, MD, NSABP Foundation Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NSABP BP-59
- NSABP-BP-59