Breast CancerNCT00089323
Diagnostic Procedures in Detecting Tumor Cells in the Bone Marrow of Patients Undergoing Surgery for Stage I, Stage II, or Stage IIIA Breast Cancer
A study testing Bone Marrow Aspiration in people with Breast Cancer, run by NSABP Foundation Inc at 53 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Bone Marrow Aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,630 participants
- Where
- 53 sitesin 2 countries
- Study dates
- Jan 2007to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
53 sites in 2 countries.
53 sites in 2 countries
United States49 sites
American Fork Hospital
American Fork, Utah, 84003
CCOP - Montana Cancer Consortium
Billings, Montana, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, 59101
St. Vincent Healthcare Cancer Care Services
Billings, Montana, 59101
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, 59102
Billings Clinic - Downtown
Billings, Montana, 59107-7000
Bozeman Deaconess Cancer Center
Bozeman, Montana, 59715
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
Fletcher Allen Health Care - University Health Center Campus
Burlington, Vermont, 05401
St. James Healthcare Cancer Care
Butte, Montana, 59701
Rocky Mountain Oncology
Casper, Wyoming, 82609
Sandra L. Maxwell Cancer Center
Cedar City, Utah, 84720
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
United Hospital Center
Clarksburg, West Virginia, 26301
Morton Plant Hospital
Clearwater, Florida, 33756
Union Hospital of Cecil County
Elkton, Maryland, 21921
Wayne Memorial Hospital, Incorporated
Goldsboro, North Carolina, 27534
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
St. Peter's Hospital
Helena, Montana, 59601
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, 77030-4009
St. Vincent's Medical Center
Jacksonville, Florida, 32204
Glacier Oncology, PLLC
Kalispell, Montana, 59901
Kalispell Medical Oncology at KRMC
Kalispell, Montana, 59901
Kalispell Regional Medical Center
Kalispell, Montana, 59901
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, 33805
Tunnell Cancer Center at Beebe Medical Center
Lewes, Delaware, 19958
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Logan Regional Hospital
Logan, Utah, 84321
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, 59807-7877
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, 59807
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, 26506
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
Murray, Utah, 84157
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
Ogden, Utah, 84403
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital
Parkersburg, West Virginia, 26102
Utah Valley Regional Medical Center - Provo
Provo, Utah, 84604
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City, Utah, 84106
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
LDS Hospital
Salt Lake City, Utah, 84143
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, 82801
Dixie Regional Medical Center - East Campus
St. George, Utah, 84770
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, 74136
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
CCOP - Main Line Health
Wynnewood, Pennsylvania, 19096
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096
Canada4 sites
Hopital Notre-Dame du CHUM
Montreal, Quebec, H2L 4M1
CHUM - Hotel Dieu Hospital
Montreal, Quebec, H2W 1T8
CHUM - Hopital Saint-Luc
Montreal, Quebec, H2X 3J4
Hopital du Saint-Sacrement - Quebec
Québec, Quebec, G1S 4L8
About this study
Official title: Bone Marrow Analysis In Early-Stage Breast Cancer
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Bone Marrow Aspiration
- Keywords
- stage IA breast cancer, stage II breast cancer, stage IIIA breast cancer, male breast cancer, stage IB breast cancer
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow AspirationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1: Bone Marrow Aspiration | Other | Not described Receives: Procedure: Bone Marrow Aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 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
Measured: As detected at time of analysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2004 (estimated)
- Study startJan 2007
- Primary completionJul 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,630 participants (actual)
Sponsor and investigators
- Lead sponsor
- NSABP Foundation Inc
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Norman Wolmark, MD, Principal investigator, NSABP Foundation Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00089323
- Sponsor's protocol ID
- NSABP BP-59
- Other IDs
- NSABP-BP-59
- Status last verified
- Oct 2021
- First submitted
- 4 Aug 2004
- Last updated
- 11 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Analysis In Early-Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT00089323
- Acronym / sponsor ID
- NSABP BP-59
- Conditions
- Breast Cancer
- Keywords
- stage IA breast cancer, stage II breast cancer, stage IIIA breast cancer, male breast cancer, stage IB breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,630 participants (actual)
- Lead sponsor
- NSABP Foundation IncResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2007
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 5 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1: Bone Marrow Aspiration | Other | Procedure: Bone Marrow Aspiration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow Aspiration | Procedure or surgery | 1: Bone Marrow Aspiration |
Primary outcome
Overall survival
Time frame: From time of randomization to death from any cause through 10 years.
1 secondary outcome
Tumor cell presence as measured by bright-field and multicolor fluorescence immunocytochemical methods
Time frame: As detected at time of analysis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman Wolmark, MD principal investigator
NSABP Foundation Inc
53 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone Marrow Aspiration in people with Breast Cancer, run by NSABP Foundation Inc at 53 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From time of randomization to death from any cause through 10 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.