Annals of Surgical Oncology

, Volume 11, Supplement 3, pp 208S–210S | Cite as

NSABP-32: Phase III, randomized trial comparing axillary resection with sentinal lymph node dissection: A description of the trial

  • David N. Krag
  • Thomas B. Julian
  • Seth P. Harlow
  • Donald L. Weaver
  • Taka Ashikaga
  • John Bryant
  • Richard M. Single
  • Norman Wolmark
Article

Abstract

The NSABP-32 trial is a randomized, phase III clinical trial to compare sentinel node (SN) resection to conventional axillary dissection in clinically node-negative breast cancer patients. The primary aims of the trial are to determine if removal of only SNs provides survival and regional control equivalent to those of axillary dissection, while diminishing the magnitude of surgically related side effects. In order to ensure consistency of the outcomes for this trial, a standardized method of SN surgery has been utilized for all cases. A secondary aim of the B32 trial is to evaluate whether patients with “occult” metastases in the SNs have worse survival. Accrual is taking place at 73 institutions in North America, and 217 surgeons are enrolling patients.

Key Words

Breast cancer Clinical trial Sentinel node Survival 

References

  1. 1.
    Cabanes PA, Salmon RJ, Vilcoq JR, et al. Value of axillary dissection in addition to lumpectomy and radiotherapy in early breast cancer. The Breast Carcinoma Collaborative Group of the Institut Curie,Lancet 1992;339:1245–8.PubMedCrossRefGoogle Scholar
  2. 2.
    Fisher B, Redmond C, Fisher ER, et al. Ten-year results of a randomized clinical trial comparing radical mastectomy and total mastectomy with or without radiation.N Engl J Med 1985;312:674–81.PubMedCrossRefGoogle Scholar
  3. 3.
    Hayward JI. The Guy's Hospital trials on breast conservation. In: Silen W, ed.Conservative Management of Breast Cancer: New Surgical and Radiotherapeutic Techniques. Philadelphia: JB Lippincott, 1983:77–90.Google Scholar
  4. 4.
    Atkins H, Hayward JL, Klugman DJ, Wayte AB. Treatment of early breast cancer: a report after ten years of a clinical trial.Br. Med J 1972;2:423–9.PubMedCrossRefGoogle Scholar
  5. 5.
    Langlands AO, Prescott RJ, Hamilton T. A clinical trial in the management of operable cancer of the breast.Br J Surg 1980;67:170–4.PubMedGoogle Scholar
  6. 6.
    Johansen H, Kaae S, Schiodt T. Simple mastectomy with postoperative irradiation versus extended radical mastectomy in breast cancer: a twenty-five-year follow-up of a randomized trial,Acta Oncol 1990;29:709–15.PubMedGoogle Scholar
  7. 7.
    Orr RK. The impact of prophylactic axillary node dissection on breast cancer survival: a Bayesian meta-analysis.Ann Surg Oncol 1999;6:109–16.PubMedCrossRefGoogle Scholar
  8. 8.
    Fisher B, Anderson S, Bryant J, et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer,N Engl J Med 2002;347:1233–41.PubMedCrossRefGoogle Scholar
  9. 9.
    Early Breast Cancer Trialists' Collaborative Group. Polychemotherapy for early breast cancer: an overview of the randomized trials.Lancet 1998;352:930–42.CrossRefGoogle Scholar
  10. 10.
    Bland KI, Scott-Conner CE, Menck H, Winchester DP. Axillary dissection in breast-conserving surgery for stage I and II breast cancer: a National Cancer Data Base study of patterns of omission and implications for survival.J Am Coll Surg 1999;188:586–95; discussion, 595–6.PubMedCrossRefGoogle Scholar
  11. 11.
    Fisher B, Slack NH. Number of lymph nodes examined and the prognosis of breast carcinoma,Surg Gynecol Obstet 1970;131:79–88.PubMedGoogle Scholar
  12. 12.
    Osborne M, Ormiston N, Harmer CL, McKinna JA, Baker J, Greening WP. Breast conservation in the treatment of early breast cancer. A 20-year follow-up.Cancer 1984;53:349–55.PubMedCrossRefGoogle Scholar

Copyright information

© The Society of Surgical Oncology, Inc. 2004

Authors and Affiliations

  • David N. Krag
    • 1
  • Thomas B. Julian
    • 3
  • Seth P. Harlow
    • 1
  • Donald L. Weaver
    • 2
  • Taka Ashikaga
    • 3
  • John Bryant
    • 4
  • Richard M. Single
    • 2
  • Norman Wolmark
    • 3
  1. 1.Department of Surgery, College of MedicineUniversity of VermontBurlington
  2. 2.Department of Pathology and Medical Statistics, College of MedicineUniversity of VermontBurlington
  3. 3.National Surgical Breast and Bowel ProjectPittsburgh
  4. 4.Uiversity of PittsburghPittsburgh

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