Completed

Bone Marrow Analysis In Early-Stage Breast Cancer

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What is being tested

Bone Marrow Aspiration

Procedure
Who is being recruted

Breast Diseases+2

+ Breast Neoplasms

+ Neoplasms

Over 18 Years
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: January 2007
See protocol details

Summary

Principal SponsorNSABP Foundation Inc
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2007

Actual date on which the first participant was enrolled.

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.

Official TitleBone Marrow Analysis In Early-Stage Breast Cancer 
NCT00089323
Principal SponsorNSABP Foundation Inc
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1630 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin Diseases

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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 53 locations

Suspended

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, United StatesSee the location
Suspended

Tunnell Cancer Center at Beebe Medical Center

Lewes, United States
Suspended

CCOP - Christiana Care Health Services

Newark, United States
Suspended

Morton Plant Hospital

Clearwater, United States
Completed53 Study Centers