Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00003854|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 13, 2016
RATIONALE: Biopsy of sentinel lymph nodes and bone marrow may improve the ability to detect and determine the extent of cancer.
PURPOSE: Phase III prognostic study of sentinel lymph node metastases and bone marrow metastases in women who have stage I or stage IIA breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: immunohistochemistry staining method Procedure: lymphangiography Procedure: sentinel lymph node biopsy Procedure: therapeutic conventional surgery Radiation: whole breast irradiation||Phase 3|
- Estimate the prevalence and evaluate the prognostic significance of sentinel lymph node micrometastases detected by immunohistochemistry in women with stage I or IIA breast cancer.
- Estimate the prevalence and evaluate the prognostic significance of bone marrow micrometastases detected by immunocytochemistry in these patients.
- Evaluate the hazard rate for regional recurrence in women whose sentinel nodes are negative by hematoxylin and eosin (H&E) staining.
- Provide a mechanism for identifying women whose sentinel nodes contain metastases detected by H&E so that these women can be considered as candidates for ACOSOG-Z0011.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4590 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer|
|Study Start Date :||April 1999|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||July 2011|
Experimental: Surgery + radiotherapy + adjuvant therapy
Patients undergo bilateral anterior iliac crest bone marrow aspiration to test for presence of micrometastases. Patients then undergo breast-conserving therapy comprising segmental mastectomy and sentinel lymph node dissection (SLND) with planned postoperative whole-breast radiotherapy and systemic adjuvant therapy. The SLND comprises ipsilateral axillary sentinel node identification and histopathology.
Patients with no sentinel node identified intraoperatively and patients with sentinel node metastasis identified by hematoxylin and eosin (H&E) who choose not to be registered to ACOSOG-Z0011 undergo axillary lymph node dissection involving removal of at least level I and II nodes.
All patients undergo whole-breast radiotherapy (excluding a supraclavicular field) 5 days a week for a maximum of 8 weeks.
Patients are followed at 30 days; at 6, 12, 18, 24, 30, and 36 months; and then annually until 10 years after surgery.
|Other: immunohistochemistry staining method Procedure: lymphangiography Procedure: sentinel lymph node biopsy Procedure: therapeutic conventional surgery Radiation: whole breast irradiation|
- Overall survival [ Time Frame: Up to 10 years ]
- Disease-free survival [ Time Frame: Up to 10 years ]
- Axillary recurrence following detection of negative SN with H&E staining in women who did not have an ALND [ Time Frame: Up to 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003854
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|Study Chair:||Armando E. Giuliano, MD||John Wayne Cancer Institute|