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.