Table 1

Ongoing randomised neoadjuvant studies targeting HER2 with new agents
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+/-

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.

Snoj et al. Breast Cancer Research 2009 11:201   doi:10.1186/bcr2209