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

Alternate Title

Lymph Node Removal in Treating Women Who Have Stage I or Stage IIA Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 and over	NCI	ACOSOG-Z0011 GUMC-00153, ACOSOG-Z0011, NCT00003855

Special Category: CTSU trial

Objectives

1. Determine whether axillary lymph node dissection (ALND) improves overall survival in women with stage I or IIA breast cancer.
2. Quantify and compare surgical morbidities associated with sentinel lymph node dissection with or without ALND in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed stage I or IIA (T1 or T2, N0, M0) invasive breast carcinoma amenable to lumpectomy
  • Tumor must be less than 5 cm
  • No palpable nodes
  • No evidence of metastatic disease
  • Cytologic diagnosis suggestive of carcinoma from a fine-needle aspiration from a palpable or nonpalpable breast lesion and clinically suspicious for invasive breast carcinoma allowed



• No concurrent bilateral breast malignancies



• Diagnosis no more than 60 days prior to sentinel lymph node dissection (SLND)



• Sentinel node must have been identified and found to contain metastatic disease



• No matted lymph nodes or gross extranodal disease



• No more than 2 positive sentinel nodes



• No clinically or radiologically identified multifocal disease not amenable to a single lumpectomy



• Hormone receptor status:
  • Estrogen receptor positive or negative

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for this breast cancer

Endocrine therapy:

• No prior estrogen receptor antagonist (i.e., tamoxifen) or selective estrogen receptor modulators therapy (i.e., raloxifene) for this breast cancer

Radiotherapy:

• Not specified

Surgery:

• Prior breast-conserving therapy (i.e., segmental mastectomy) allowed if no more than 60 days prior to SLND
• No pre-pectoral breast implant
  • Subpectoral implant allowed
• No prior ipsilateral axillary surgery (e.g., excisional biopsy of the lymph nodes or treatment of hidradenitis)

Patient Characteristics:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• ECOG (Zubrod) 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• Must not be considered a poor surgical risk due to any other nonmalignant systemic disease
• No other prior malignancies within the past 5 years except successfully treated basal cell or squamous cell skin cancer or surgically treated carcinoma in situ of the cervix or lobular carcinoma in situ of the ipsilateral or contralateral breast
• All prior malignancies must have been curatively treated and risk of recurrence must be low
• Not pregnant or nursing
• Negative pregnancy test
• No other medical condition contraindicating axillary lymph node dissection or postoperative breast radiotherapy

Expected Enrollment

Approximately 1,900 patients (950 per treatment arm) will be accrued for this study within 3.8 years.

Outline

This is a randomized study. After segmental mastectomy and sentinel lymph node dissection, patients are stratified according to age (50 and under vs over 50), estrogen receptor status (positive vs negative), and tumor size (no greater than 1 cm vs greater than 1 cm but no greater than 2 cm vs greater than 2 cm). Patients are randomized to one of two treatment arms.

• Arm I: Patients undergo axillary lymph node dissection involving removal of at least level I and II nodes, followed by whole breast radiotherapy (exclusive of a third supraclavicular field) 5 days a week for a maximum of 7 weeks.



• Arm II: Patients undergo breast radiotherapy only as in arm I.

Patients in both arms may receive adjuvant systemic therapy at the discretion of the treating physician.

Patients are followed at 30 days, at 6, 12, 18, 30, and 36 months, and then annually thereafter.

Lucci A, McCall LM, Beitsch PD, et al.: Surgical complications associated with sentinel lymph node dissection (SLND) plus axillary lymph node dissection compared with SLND alone in the American College of Surgeons Oncology Group Trial Z0011. J Clin Oncol 25 (24): 3657-63, 2007.[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]

Leitch AM, McCall L, Beitsch P, et al.: Factors influencing accrual to ACOSOG Z0011, a randomized phase III trial of axillary dissection vs. observation for sentinel node positive breast cancer. [Abstract] J Clin Oncol 24 (Suppl 18): A-601, 2006.

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

Registry Information
Official Title		A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node
Trial Start Date		1999-04-30
Registered in ClinicalTrials.gov		NCT00003855
Date Submitted to PDQ		1999-04-08
Information Last Verified		2004-09-08
NCI Grant/Contract Number		CA76001