Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Related Publications
Trial Contact Information
Related Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Diagnostic, Treatment	Closed	Over 18	NCI	ACOSOG-Z0010 GUMC-00152, NCT00003854

Objectives

1. 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.
2. Estimate the prevalence and evaluate the prognostic significance of bone marrow micrometastases detected by immunocytochemistry in these patients.
3. Evaluate the hazard rate for regional recurrence in women whose sentinel nodes are negative by hematoxylin and eosin (H&E) staining.
4. 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.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• 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

Radiotherapy:

• Not specified

Surgery:

• 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

Patient Characteristics:

Age:

• Over 18

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2

  OR

• Zubrod 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• No renal disease that would increase surgical risk

Cardiovascular:

• No cardiovascular disease that would increase surgical risk

Other:

• 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

Expected Enrollment

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

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 thereafter.

Wilke LG, McCall LM, Posther KE, et al.: Surgical complications associated with sentinel lymph node biopsy: results from a prospective international cooperative group trial. Ann Surg Oncol 13 (4): 491-500, 2006.[PUBMED Abstract]

Leitch AM, Beitsch PD, McCall LM, et al.: Patterns of participation and successful patient recruitment to American College of Surgeons Oncology Group Z0010, a phase II trial for patients with early-stage breast cancer. Am J Surg 190 (4): 539-42, 2005.[PUBMED Abstract]

Posther KE, McCall LM, Blumencranz PW, et al.: Sentinel node skills verification and surgeon performance: data from a multicenter clinical trial for early-stage breast cancer. Ann Surg 242 (4): 593-9; discussion 599-602, 2005.[PUBMED Abstract]

Olson JA Jr, McCall LM, Beitsch P, et al.: Impact of immediate versus delayed axillary node dissection on surgical outcomes in breast cancer patients with positive sentinel nodes: results from American College of Surgeons Oncology Group Trials Z0010 and Z0011. J Clin Oncol 26 (21): 3530-5, 2008.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

American College of Surgeons Oncology Group

Armando Giuliano, MD, Protocol chair		Ph: 310-829-8089 Email: giulianoa@jwci.org

Related Information

PDQ® clinical trial ACOSOG-Z0011

Registry Information
Official Title		A Prognostic Study of Sentinel Node and Bone Marrow Micrometastases in Women with Clinical T1-2 N0 Breast Cancer
Trial Start Date		1999-04-30
Registered in ClinicalTrials.gov		NCT00003854
Date Submitted to PDQ		1999-04-08
Information Last Verified		2001-07-30
NCI Grant/Contract Number		CA76001