Clinical trial

Breast Cancer Research and Treatment

, Volume 142, Issue 2, pp 415-421

First online:

Preliminary results of centralized HER2 testing in ductal carcinoma in situ (DCIS): NSABP B-43

  • Kalliopi P. SiziopikouAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Northwestern University Feinberg School of Medicine
  • , Stewart J. AndersonAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Department of Biostatistics, NSABP Biostatistical Center, University of Pittsburgh Graduate School of Public Health
  • , Melody A. CobleighAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Rush University Medical Center
  • , Thomas B. JulianAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Allegheny Cancer Center, Allegheny General Hospital Email author 
  • , Douglas W. ArthurAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Virginia Commonwealth University
  • , Ping ZhengAffiliated withDepartment of Biostatistics, NSABP Biostatistical Center, University of Pittsburgh Graduate School of Public Health
  • , Eleftherios P. MamounasAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Aultman Hospital
  • , Eduardo R. PajonAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Colorado Cancer Research Program
  • , Robert J. BehrensAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Iowa Oncology Research Association
    • , Janice F. EakleAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Florida Cancer Specialists
    • , Nick C. LeasureAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)McGlinn Family Cancer Center at Reading Regional Hospital
    • , James N. AtkinsAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Southeast Cancer Control Consortium-CCOP
    • , Jonathan A. PolikoffAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Kaiser Permanente Southern California
    • , Thomas E. SeayAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Atlanta Regional Community Clinical Oncology Program
    • , Worta J. McCaskill-StevensAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Division of Cancer Prevention, National Cancer Institute
    • , Rachel RabinovitchAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)University of Colorado
    • , Joseph P. CostantinoAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Department of Biostatistics, NSABP Biostatistical Center, University of Pittsburgh Graduate School of Public Health
    • , Norman WolmarkAffiliated withNational Surgical Adjuvant Breast and Bowel Project (NSABP)Allegheny Cancer Center, Allegheny General Hospital

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Abstract

NSABP B-43 is the first prospective, randomized phase III multi-institution clinical trial targeting high-risk, HER2-positive DCIS. It compares whole breast irradiation alone with WBI given concurrently with trastuzumab in women with HER2-positive DCIS treated by lumpectomy. The primary aim is to determine if trastuzumab plus radiation will reduce in-breast tumor recurrence. HER2-positive DCIS was previously estimated at >50 %, occurring primarily in ER-negative, comedo-type DCIS of high nuclear grade. There has been no documented centralized multi-institutional HER2 analysis of DCIS. NSABP B-43 provides a unique opportunity to evaluate this in a large cohort of DCIS patients. Patients undergoing lumpectomy for DCIS without evidence of an invasive component are eligible. A central review of each patient’s pure DCIS lesion is carried out by immunohistochemistry analysis. If the lesion is 2+, FISH analysis is performed. Patients whose tumors are HER2 3+ or FISH-positive are randomly assigned to receive two doses of trastuzumab during WBI or WBI alone. NSABP B-43 opened 11/9/08. As of 7/31/2013, 5,861 patients have had specimens received centrally, and 5,645 of those had analyzable blocks; 1,969 (34.9 %) were HER2 positive. A total of 1,428 patients have been accrued, 1,137 (79.6 %) of whom have follow-up information. The average follow-up time for the 1,137 patients is 23.3 months. No grade 4 or 5 toxicity has been observed. In NSABP B-43 the HER2-positive rate for pure DCIS among patients undergoing breast-preserving surgery is 34.9 %, lower than the previously reported rate. No trastuzumab-related safety signals have been observed. Interest in this trial has been robust.

Keywords

DCIS Non-invasive breast cancer HER2 Clinical trials