Skip to main content

Table 1 Ongoing randomised neoadjuvant studies targeting HER2 with new agents

From: Are we HER-ting for innovation in neoadjuvant breast cancer trial design?

ClinicalTrials.gov identifier Sponsor and participating groups Investigational drugs Phase Estimated enrolment Status Start/Completion Primary endpoint Translational research Patient eligibility (all HER2+)
NCT00486668 [16] NSABP Lapatinib Trastuzumab III 522 Recruiting July 2007 to July 2014a - pCR (breast only) GEP ER+/- PR+/-
NCT00499681 [17] Vanderbilt-Ingram Cancer Center (Nashville, TN, USA) NCI Lapatinib Letrozole II 36 Recruiting July 2007 to July 2010 - Change in percentage of Ki67+ tumour cells – pCR Biomarkersb Imaging ER+ and/or PR+
NCT00450892 [18] EORTC Lapatinib Trastuzumab I–II 114 Recruiting Feb. 2007 to Dec. 2009 - pCRc – Safety and tolerability –
RR – Phdinam.
GEP Phdinam. ER+/- PR+/- Inflammatory BC Included
NCT00567554 GeparQuinto [19] GBG AGO Ovarian Cancer Study Group Lapatinib Trastuzumab III 2,547 (all patients) Recruiting Oct. 2007 to Dec. 2015 - pCR Biomarkers CTCs Imaging Phgen. ER+/- PR+/- Inflammatory BC Included
NCT00674414 [20] Fédération Nationale des Centres de Lutte Contre le Cancer (Paris, France) Everolimus Trastuzumab II 120 Recruiting Apr. 2008 to Apr. 2014 - RR (clinical and echographic) Phgen. Phdinam. Proteomics Biomarkers ER+/- PR+/-
NCT00545688 [21] Hoffmann-La Roche (Grenzach-Wyhlen, Germany) Pertuzumab Trastuzumab II 400 Recruiting Dec. 2007 to Oct. 2014 - pCR NR ER+/- PR+/- Inflammatory BC Included
NCT00524303 [22] GSK Trastuzumab Lapatinib II 99 Recruiting Sept. 2007 to July 2013 - Pathologic RR Biomarkers ER+/- PR+/- Inflammatory BC Included
NCT0053358 [23] GSK BIG Grupo Espaniol de Estudio Tratamiento y Otras Estrategias Experimentales en Tumores Solidos (Madrid, Spain) Trastuzumab Lapatinib III 450 Recruiting Sept. 2007 to Sept. 2019 - pCR (breast only) Biomarkers Imaging CTCs  
NCT00548184 [24] Baylor Breast Cancer Center (Houston, TX, USA) GSK Lapatinib Trastuzumab II 64 Not yet recruiting Jan. 2008 to Jan. 2012 Biomarkers Biomarkers ER+/- PR+/-
  1. aIncluding the follow-up period; btranslational research described as biomarkers in which no additional information about the techniques was given; conly for phase II part. AGO, Arbeitsgemeinschaft Gynäkologische Onkologie; BC, breast cancer; BIG, Breast International Group (Brussels, Belgium); CTCs, circulating tumour cells; EORTC, European Organisation for Research and Treatment of Cancer; ER, oestrogen receptor; GBG, German Breast Group (Neu-Isenburg, Germany); GEP, gene expression profiling; GSK, GlaxoSmithKline (Uxbridge, Middlesex, UK); HER2, human epidermal growth factor receptor 2; NCI, National Cancer Institute (Bethesda, MD, USA); NSABP, National Surgical Adjuvant Breast and Bowel Project; NR, not reported; pCR, pathologic complete response; Phdinam., pharmacodynamics; Phgen., pharmacogenetics; PR, progesterone receptor; RR, response rate.