Breast Cancer Clinical Trial
Diagnostic Procedures in Detecting Tumor Cells in the Bone Marrow of Patients Undergoing Surgery for Stage I, Stage II, or Stage IIIA Breast Cancer
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.
Full 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.
Eligibility 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.
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There are 46 Locations for this study
Little Rock Arkansas, 72205, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19713, United States
Clearwater Florida, 33756, United States
Jacksonville Florida, 32204, United States
Lakeland Florida, 33805, United States
Elkton Maryland, 21921, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59102, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Havre Montana, 59501, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59807, United States
Missoula Montana, 59807, United States
Voorhees New Jersey, 08043, United States
Charlotte North Carolina, 28232, United States
Goldsboro North Carolina, 27534, United States
Winston-Salem North Carolina, 27157, United States
Tulsa Oklahoma, 74136, United States
Bryn Mawr Pennsylvania, 19010, United States
Paoli Pennsylvania, 19301, United States
Wynnewood Pennsylvania, 19096, United States
Wynnewood Pennsylvania, 19096, United States
Houston Texas, 77030, United States
American Fork Utah, 84003, United States
Cedar City Utah, 84720, United States
Logan Utah, 84321, United States
Murray Utah, 84157, United States
Ogden Utah, 84403, United States
Provo Utah, 84604, United States
Saint George Utah, 84770, United States
Salt Lake City Utah, 84106, United States
Salt Lake City Utah, 84112, United States
Salt Lake City Utah, 84143, United States
Burlington Vermont, 05401, United States
Clarksburg West Virginia, 26301, United States
Morgantown West Virginia, 26506, United States
Parkersburg West Virginia, 26102, United States
Casper Wyoming, 82609, United States
Sheridan Wyoming, 82801, United States
Montreal Quebec, H2L 4, Canada
Montreal Quebec, H2W 1, Canada
Montreal Quebec, H2X 3, Canada
Quebec City Quebec, G1S 4, Canada
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