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Bone Marrow Analysis In Early-Stage Breast Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer

Thank you

Trial Information

Bone Marrow Analysis In Early-Stage Breast Cancer


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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Overall survival

Outcome Time Frame:

From time of randomization to death from any cause through 10 years.

Safety Issue:

No

Principal Investigator

Norman Wolmark, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Surgical Adjuvant Breast and Bowel Project (NSABP)

Authority:

United States: Federal Government

Study ID:

NSABP BP-59

NCT ID:

NCT00089323

Start Date:

January 2007

Completion Date:

April 2016

Related Keywords:

  • Breast Cancer
  • stage IA breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • male breast cancer
  • stage IB breast cancer
  • Breast Neoplasms

Name

Location

CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
LDS HospitalSalt Lake City, Utah  84143
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Fletcher Allen Health Care - University Health Center CampusBurlington, Vermont  05401
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Mary Babb Randolph Cancer Center at West Virginia University HospitalsMorgantown, West Virginia  26506
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Peter's HospitalHelena, Montana  59601
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Lakeland Regional Cancer Center at Lakeland Regional Medical CenterLakeland, Florida  33805
Cancer Institute of New Jersey at Cooper - VoorheesVoorhees, New Jersey  08043
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Tunnell Cancer Center at Beebe Medical CenterLewes, Delaware  19958
Billings Clinic - DowntownBillings, Montana  59107-7000
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
St. James Healthcare Cancer CareButte, Montana  59701
Great Falls Clinic - Main FacilityGreat Falls, Montana  59405
Sletten Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Northern Montana HospitalHavre, Montana  59501
Kalispell Medical Oncology at KRMCKalispell, Montana  59901
Sandra L. Maxwell Cancer CenterCedar City, Utah  84720
Jon and Karen Huntsman Cancer Center at Intermountain Medical CenterMurray, Utah  84157
Val and Ann Browning Cancer Center at McKay-Dee Hospital CenterOgden, Utah  84403
Community Comprehensive Cancer Center at Camden-Clark Memorial HospitalParkersburg, West Virginia  26102
Rocky Mountain OncologyCasper, Wyoming  82609
Morton Plant HospitalClearwater, Florida  33756
Union Hospital of Cecil CountyElkton MD, Maryland  21921
St. Vincent's Medical CenterJacksonville, Florida  32203
St. Vincent Healthcare Cancer Care ServicesBillings, Montana  59101
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
CCOP - Main Line HealthWynnewood, Pennsylvania  19096
United Hospital CenterClarksburg, West Virginia  26301