Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: August 18, 2012
Last verified: July 2001

November 1, 1999
August 18, 2012
April 1999
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Complete list of historical versions of study NCT00003854 on Archive Site
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Prognostic Study of Sentinel Lymph Node and Bone Marrow Metastases in Women With Stage I or Stage IIA Breast Cancer
A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer

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.


  • 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.

OUTLINE: 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.

PROJECTED ACCRUAL: A total of 5,300 patients will be accrued for this study within an additional 3 years.

Phase 3
Primary Purpose: Diagnostic
Breast Cancer
  • Other: immunohistochemistry staining method
  • Procedure: lymphangiography
  • Procedure: sentinel lymph node biopsy
  • Procedure: therapeutic conventional surgery
  • Radiation: whole breast irradiation
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
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  • Histologically or cytologically confirmed stage I or IIA (T1 or T2 N0 M0) invasive breast carcinoma diagnosed within 60 days of sentinel lymph node dissection

    • Cytologic diagnosis suggestive of carcinoma from a fine needle aspiration of a palpable or nonpalpable breast lesion allowed if clinically suspicious for invasive breast carcinoma
    • Tumor must be amenable to segmental mastectomy (lumpectomy)
    • No clinically and radiologically identified multicentric disease that is not amenable to a single lumpectomy
    • No concurrent bilateral invasive breast malignancies
  • No tumors in the medial hemisphere of the breast that show complete absence of drainage to the axilla by lymphoscintigram
  • Hormone receptor status:

    • Not specified



  • Over 18


  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2 OR
  • Zubrod 0-2

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • No renal disease that would increase surgical risk


  • No cardiovascular disease that would increase surgical risk


  • No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, surgically treated carcinoma in situ of the cervix, or curatively treated lobular carcinoma in situ of the ipsilateral or contralateral breast with a low risk of recurrence
  • No other nonmalignant systemic disease that would increase surgical risk
  • No active connective tissue disorders
  • Able to undergo and have access to radiotherapy
  • Physically able to undergo bilateral anterior iliac crest bone marrow aspiration
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • No prior chemotherapy for invasive breast cancer

Endocrine therapy:

  • No prior estrogen-receptor antagonists (e.g., tamoxifen) or selective estrogen-receptor modulators (e.g., raloxifene) for invasive breast cancer


  • Not specified


  • See Disease Characteristics
  • No prior ipsilateral axillary surgery (e.g., excisional biopsy of lymph nodes or treatment of hidradenitis)
  • No pre-pectoral breast implant
  • Subpectoral implant allowed
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Ireland
CDR0000067017, ACOSOG-Z0010, GUMC-00152
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American College of Surgeons
National Cancer Institute (NCI)
Study Chair: Armando E. Giuliano, MD John Wayne Cancer Institute at Saint John's Health Center
National Cancer Institute (NCI)
July 2001

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