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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Bone Marrow Aspiration
Sponsored by
NSABP Foundation Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring stage IA breast cancer, stage II breast cancer, stage IIIA breast cancer, male breast cancer, stage IB breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
  • Tunnell Cancer Center at Beebe Medical Center
  • CCOP - Christiana Care Health Services
  • Morton Plant Hospital
  • St. Vincent's Medical Center
  • Lakeland Regional Cancer Center at Lakeland Regional Medical Center
  • Union Hospital of Cecil County
  • CCOP - Montana Cancer Consortium
  • Northern Rockies Radiation Oncology Center
  • St. Vincent Healthcare Cancer Care Services
  • Hematology-Oncology Centers of the Northern Rockies - Billings
  • Billings Clinic - Downtown
  • Bozeman Deaconess Cancer Center
  • St. James Healthcare Cancer Care
  • Great Falls Clinic - Main Facility
  • Sletten Cancer Institute at Benefis Healthcare
  • Northern Montana Hospital
  • St. Peter's Hospital
  • Glacier Oncology, PLLC
  • Kalispell Medical Oncology at KRMC
  • Kalispell Regional Medical Center
  • Montana Cancer Specialists at Montana Cancer Center
  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
  • Cancer Institute of New Jersey at Cooper - Voorhees
  • Blumenthal Cancer Center at Carolinas Medical Center
  • Wayne Memorial Hospital, Incorporated
  • Wake Forest University Comprehensive Cancer Center
  • Natalie Warren Bryant Cancer Center at St. Francis Hospital
  • Bryn Mawr Hospital
  • Cancer Center of Paoli Memorial Hospital
  • CCOP - Main Line Health
  • Lankenau Cancer Center at Lankenau Hospital
  • M. D. Anderson Cancer Center at University of Texas
  • American Fork Hospital
  • Sandra L. Maxwell Cancer Center
  • Logan Regional Hospital
  • Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
  • Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
  • Utah Valley Regional Medical Center - Provo
  • Dixie Regional Medical Center - East Campus
  • Utah Cancer Specialists at UCS Cancer Center
  • Huntsman Cancer Institute at University of Utah
  • LDS Hospital
  • Fletcher Allen Health Care - University Health Center Campus
  • United Hospital Center
  • Mary Babb Randolph Cancer Center at West Virginia University Hospitals
  • Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
  • Rocky Mountain Oncology
  • Welch Cancer Center at Sheridan Memorial Hospital
  • Hopital Notre-Dame du CHUM
  • CHUM - Hotel Dieu Hospital
  • CHUM - Hopital Saint-Luc
  • Hopital du Saint-Sacrement - Quebec

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1: Bone Marrow Aspiration

Arm Description

Outcomes

Primary Outcome Measures

Overall survival

Secondary Outcome Measures

Tumor cell presence as measured by bright-field and multicolor fluorescence immunocytochemical methods

Full Information

First Posted
August 4, 2004
Last Updated
October 4, 2021
Sponsor
NSABP Foundation Inc
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00089323
Brief Title
Diagnostic Procedures in Detecting Tumor Cells in the Bone Marrow of Patients Undergoing Surgery for Stage I, Stage II, or Stage IIIA Breast Cancer
Official Title
Bone Marrow Analysis In Early-Stage Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NSABP Foundation Inc
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IA breast cancer, stage II breast cancer, stage IIIA breast cancer, male breast cancer, stage IB breast cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1630 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1: Bone Marrow Aspiration
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Bone Marrow Aspiration
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
From time of randomization to death from any cause through 10 years.
Secondary Outcome Measure Information:
Title
Tumor cell presence as measured by bright-field and multicolor fluorescence immunocytochemical methods
Time Frame
As detected at time of analysis.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman Wolmark, MD
Organizational Affiliation
NSABP Foundation Inc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Tunnell Cancer Center at Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
St. Vincent's Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Union Hospital of Cecil County
City
Elkton
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Northern Rockies Radiation Oncology Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
St. Vincent Healthcare Cancer Care Services
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies - Billings
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Billings Clinic - Downtown
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Bozeman Deaconess Cancer Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
St. James Healthcare Cancer Care
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Great Falls Clinic - Main Facility
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Sletten Cancer Institute at Benefis Healthcare
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Northern Montana Hospital
City
Havre
State/Province
Montana
ZIP/Postal Code
59501
Country
United States
Facility Name
St. Peter's Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology, PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Medical Oncology at KRMC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Montana Cancer Specialists at Montana Cancer Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807-7877
Country
United States
Facility Name
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807
Country
United States
Facility Name
Cancer Institute of New Jersey at Cooper - Voorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
Facility Name
Natalie Warren Bryant Cancer Center at St. Francis Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Bryn Mawr Hospital
City
Bryn Mawr
State/Province
Pennsylvania
ZIP/Postal Code
19010
Country
United States
Facility Name
Cancer Center of Paoli Memorial Hospital
City
Paoli
State/Province
Pennsylvania
ZIP/Postal Code
19301-1792
Country
United States
Facility Name
CCOP - Main Line Health
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Lankenau Cancer Center at Lankenau Hospital
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
American Fork Hospital
City
American Fork
State/Province
Utah
ZIP/Postal Code
84003
Country
United States
Facility Name
Sandra L. Maxwell Cancer Center
City
Cedar City
State/Province
Utah
ZIP/Postal Code
84720
Country
United States
Facility Name
Logan Regional Hospital
City
Logan
State/Province
Utah
ZIP/Postal Code
84321
Country
United States
Facility Name
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States
Facility Name
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Utah Valley Regional Medical Center - Provo
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Dixie Regional Medical Center - East Campus
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
Utah Cancer Specialists at UCS Cancer Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Huntsman Cancer Institute at University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
Fletcher Allen Health Care - University Health Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
United Hospital Center
City
Clarksburg
State/Province
West Virginia
ZIP/Postal Code
26301
Country
United States
Facility Name
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
City
Parkersburg
State/Province
West Virginia
ZIP/Postal Code
26102
Country
United States
Facility Name
Rocky Mountain Oncology
City
Casper
State/Province
Wyoming
ZIP/Postal Code
82609
Country
United States
Facility Name
Welch Cancer Center at Sheridan Memorial Hospital
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States
Facility Name
Hopital Notre-Dame du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
CHUM - Hotel Dieu Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
CHUM - Hopital Saint-Luc
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3J4
Country
Canada
Facility Name
Hopital du Saint-Sacrement - Quebec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada

12. IPD Sharing Statement

Learn more about this 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

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