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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
National Surgical Adjuvant Breast and Bowel Project (NSABP)
ClinicalTrials.gov Identifier:
NCT00089323
First received: August 4, 2004
Last updated: December 19, 2013
Last verified: December 2013

August 4, 2004
December 19, 2013
January 2007
April 2016   (final data collection date for primary outcome measure)
Overall survival [ Time Frame: From time of randomization to death from any cause through 10 years. ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00089323 on ClinicalTrials.gov Archive Site
Tumor cell presence as measured by bright-field and multicolor fluorescence immunocytochemical methods [ Time Frame: As detected at time of analysis. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Diagnostic Procedures in Detecting Tumor Cells in the Bone Marrow of Patients Undergoing Surgery for Stage I, Stage II, or Stage IIIA Breast Cancer
Bone Marrow Analysis In Early-Stage Breast Cancer

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
Procedure: Bone Marrow Aspiration
1: Bone Marrow Aspiration
Intervention: Procedure: Bone Marrow Aspiration
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
1630
April 2016
April 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00089323
NSABP BP-59, NSABP-BP-59
No
National Surgical Adjuvant Breast and Bowel Project (NSABP)
National Surgical Adjuvant Breast and Bowel Project (NSABP)
National Cancer Institute (NCI)
Principal Investigator: Norman Wolmark, MD National Surgical Adjuvant Breast and Bowel Project (NSABP)
National Surgical Adjuvant Breast and Bowel Project (NSABP)
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP