Diagnostic Procedures in Detecting Tumor Cells in the Bone Marrow of Patients Undergoing Surgery for Stage I, Stage II, or Stage IIIA Breast Cancer
Bone Marrow Analysis In Early-Stage Breast Cancer
2 other identifiers
interventional
1,630
2 countries
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jan 2007
Longer than P75 for not_applicable breast-cancer
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2004
CompletedFirst Posted
Study publicly available on registry
August 5, 2004
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedOctober 11, 2021
October 1, 2021
11.5 years
August 4, 2004
October 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
From time of randomization to death from any cause through 10 years.
Secondary Outcomes (1)
Tumor cell presence as measured by bright-field and multicolor fluorescence immunocytochemical methods
As detected at time of analysis.
Study Arms (1)
1: Bone Marrow Aspiration
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NSABP Foundation Inclead
- National Cancer Institute (NCI)collaborator
Study Sites (53)
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, 59107-7000, 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, 59807-7877, 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 Township, New Jersey, 08043, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28232-2861, United States
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534, United States
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096, 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, 19301-1792, 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, 77030-4009, 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
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
Dixie Regional Medical Center - East Campus
St. George, Utah, 84770, 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 4M1, Canada
CHUM - Hotel Dieu Hospital
Montreal, Quebec, H2W 1T8, Canada
CHUM - Hopital Saint-Luc
Montreal, Quebec, H2X 3J4, Canada
Hopital du Saint-Sacrement - Quebec
Québec, Quebec, G1S 4L8, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Norman Wolmark, MD
NSABP Foundation Inc
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2004
First Posted
August 5, 2004
Study Start
January 1, 2007
Primary Completion
July 1, 2018
Study Completion
August 1, 2018
Last Updated
October 11, 2021
Record last verified: 2021-10