Completed

Bone Marrow Analysis In Early-Stage Breast Cancer

What is being tested

Bone Marrow Aspiration

Procedure

Who is being recruted

Breast Diseases+4

+ Breast Neoplasms

+ Neoplasms

Over 18 Years

+7 Eligibility Criteria

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: January 28, 2026

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: January 28, 2026

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 DiseasesSkin and Connective Tissue DiseasesBreast Neoplasms, Male

Criteria

2 inclusion criteria required to participate

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).

5 exclusion criteria prevent from participating

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).

Show More Criteria

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 StatesOpen Arkansas Cancer Research Center at University of Arkansas for Medical Sciences in Google Maps

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