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A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 Breast Cancer

Phase 3
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women With Clinical T1-2 N0 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

- 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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Primary Purpose: Diagnostic

Principal Investigator

Armando E. Giuliano, MD

Investigator Role:

Study Chair

Investigator Affiliation:

John Wayne Cancer Institute at Saint John's Health Center


United States: Federal Government

Study ID:




Start Date:

April 1999

Completion Date:

Related Keywords:

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



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