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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosed18 and overNCI, OtherCDR0000067018
ACOSOG-Z0011, GUMC-00153, NCT00003855

Trial Description


RATIONALE: Surgery to remove lymph nodes in the armpit may remove cancer cells that have spread from tumors in the breast.

PURPOSE: Randomized phase III trial to determine the effectiveness of removing lymph nodes in the armpit in treating women who have stage I or stage IIA breast cancer.

Further Study Information


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

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 up at 30 days, at 6, 12, 18, 30, and 36 months, and then annually for a total of 10 years.

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

Eligibility Criteria


  • 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



  • 18 and over


  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG (Zubrod) 0-2

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy:

  • Not specified


  • 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


  • Not specified


  • 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)

Trial Contact Information

Trial Lead Organizations/Sponsors

American College of Surgeons

  • National Cancer Institute
Armando E. Giuliano, Study Chair

Link to the current record.
NLM Identifier NCT00003855 processed this data on January 22, 2015

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to