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

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00089323

Run by

NSABP Foundation Inc

People needed

1630

Starts

2007-01-01

Expected to finish

2018-08-01

Last updated by the study team

2021-10-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Tunnell Cancer Center at Beebe Medical Center — Lewes, Delaware, United States
• CCOP - Christiana Care Health Services — Newark, Delaware, United States
• Morton Plant Hospital — Clearwater, Florida, United States
• St. Vincent's Medical Center — Jacksonville, Florida, United States
• Lakeland Regional Cancer Center at Lakeland Regional Medical Center — Lakeland, Florida, United States
• Union Hospital of Cecil County — Elkton, Maryland, United States
• CCOP - Montana Cancer Consortium — Billings, Montana, United States
• Northern Rockies Radiation Oncology Center — Billings, Montana, United States
• St. Vincent Healthcare Cancer Care Services — Billings, Montana, United States
• Hematology-Oncology Centers of the Northern Rockies - Billings — Billings, Montana, United States
• Billings Clinic - Downtown — Billings, Montana, United States
• Bozeman Deaconess Cancer Center — Bozeman, Montana, United States
• St. James Healthcare Cancer Care — Butte, Montana, United States
• Great Falls Clinic - Main Facility — Great Falls, Montana, United States
• Sletten Cancer Institute at Benefis Healthcare — Great Falls, Montana, United States
• Northern Montana Hospital — Havre, Montana, United States
• St. Peter's Hospital — Helena, Montana, United States
• Glacier Oncology, PLLC — Kalispell, Montana, United States
• Kalispell Medical Oncology at KRMC — Kalispell, Montana, United States
• Kalispell Regional Medical Center — Kalispell, Montana, United States
• Montana Cancer Specialists at Montana Cancer Center — Missoula, Montana, United States
• Montana Cancer Center at St. Patrick Hospital and Health Sciences Center — Missoula, Montana, United States
• Cancer Institute of New Jersey at Cooper - Voorhees — Voorhees Township, New Jersey, United States
• Blumenthal Cancer Center at Carolinas Medical Center — Charlotte, North Carolina, United States
• Arkansas Cancer Research Center at University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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