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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2004 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003855
First received: November 1, 1999
Last updated: January 29, 2013
Last verified: September 2004
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Procedure: axillary lymph node dissection
Radiation: whole breast irradiation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 1900
Study Start Date: April 1999
Detailed Description:

OBJECTIVES:

  • 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003855

  Show 156 Study Locations
Sponsors and Collaborators
American College of Surgeons
Investigators
Study Chair: Armando E. Giuliano, MD John Wayne Cancer Institute at Saint John's Health Center
  More Information

Additional Information:
Publications:
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.

ClinicalTrials.gov Identifier: NCT00003855     History of Changes
Other Study ID Numbers: CDR0000067018, ACOSOG-Z0011, GUMC-00153
Study First Received: November 1, 1999
Last Updated: January 29, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IA breast cancer
stage IB breast cancer
stage II breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 20, 2014