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):
NSABP Foundation Inc
ClinicalTrials.gov Identifier:
NCT00089323
First received: August 4, 2004
Last updated: December 19, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Procedure: Bone Marrow Aspiration

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Bone Marrow Analysis In Early-Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by NSABP Foundation Inc:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From time of randomization to death from any cause through 10 years. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1630
Study Start Date: January 2007
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Bone Marrow Aspiration Procedure: Bone Marrow Aspiration

Detailed 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00089323

  Show 53 Study Locations
Sponsors and Collaborators
NSABP Foundation Inc
Investigators
Principal Investigator: Norman Wolmark, MD NSABP Foundation Inc
  More Information

Additional Information:
No publications provided

Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT00089323     History of Changes
Other Study ID Numbers: NSABP BP-59, NSABP-BP-59
Study First Received: August 4, 2004
Last Updated: December 19, 2013
Health Authority: United States: Federal Government

Keywords provided by NSABP Foundation Inc:
stage IA breast cancer
stage II breast cancer
stage IIIA breast cancer
male breast cancer
stage IB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014