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A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node

Phase 3
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node


- 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.

Inclusion 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

- 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)

Type of Study:


Study Design:

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

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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