221
Views
3
CrossRef citations to date
0
Altmetric
Clinical Trial Report

Clinical practice-changing trials: the HERA study paradigm

, &
Pages 1249-1256 | Published online: 10 Jan 2014

References

  • Yarden Y, Sliwkowski MX. Untangling the ErbB signalling network. Nat. Rev. Mol. Cell Biol. 2(2), 127–137 (2001).
  • Slamon DJ, Clark GM, Wong SG, Levin WJ, Ullrich A, McGuire WL. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 235(4785), 177–182 (1987).
  • Hudis CA. Trastuzumab--mechanism of action and use in clinical practice. N. Engl. J. Med. 357(1), 39–51 (2007).
  • Slamon DJ, Leyland-Jones B, Shak S et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N. Engl. J. Med. 344(11), 783–792 (2001).
  • Piccart-Gebhart MJ, Procter M, Leyland-Jones B et al. Trastuzumab after Adjuvant Chemotherapy in HER2-Positive Breast Cancer. N. Engl. J. Med. 353(16), 1659–1672 (2005).
  • Romond EH, Perez EA, Bryant J et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N. Engl. J. Med. 353(16), 1673–1684 (2005).
  • Smith I, Procter M, Gelber RD et al. 2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomised controlled trial. Lancet 369(9555), 29–36 (2007).
  • Gianni L, Dafni U, Gelber RD et al. Treatment with trastuzumab for 1 year after adjuvant chemotherapy in patients with HER2-positive early breast cancer: a 4-year follow-up of a randomised controlled trial. Lancet Oncol. 12(3), 236–244 (2011).
  • Goldhirsch A, Gelber RD, Piccart-Gebhart MJ et al. 2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial. Lancet 382(9897), 1021–1028 (2013).
  • Joensuu H. Duration of adjuvant trastuzumab: shorter beats longer. Lancet 382(9897), 1010–1011 (2013).
  • Pivot X, Romieu G, Debled M et al. 6 months versus 12 months of adjuvant trastuzumab for patients with HER2-positive early breast cancer (PHARE): a randomised phase 3 trial. Lancet Oncol. 14(8), 741–748 (2013).
  • Bria E, Cuppone F, Fornier M et al. Cardiotoxicity and incidence of brain metastases after adjuvant trastuzumab for early breast cancer: the dark side of the moon? a meta-analysis of the randomized trials. Breast Cancer Res. Treat. 109(2), 231–239 (2007).
  • Pestalozzi BC, Holmes E, de Azambuja E et al. CNS relapses in patients with HER2-positive early breast cancer who have and have not received adjuvant trastuzumab: a retrospective substudy of the HERA trial (BIG 1-01). Lancet Oncol. 14(3), 244–248 (2013).
  • De Azambuja E, Bedard PL, Suter T, Piccart-Gebhart M. Cardiac toxicity with anti-HER-2 therapies: what have we learned so far? Target Oncol. 4(2), 77–88 (2009).
  • Procter M, Suter TM, de Azambuja E et al. Longer-Term Assessment of Trastuzumab-Related C ardiac Adverse Events in the Herceptin Adjuvant (HERA) Trial. J. Clin. Oncol. 28(21), 3422–3428 (2010).
  • De Azambuja E, Procter M, van Veldhuisen DJ et al. Long-term (8 years) assessment of trastuzumab-related cardiac events in the HERA trial. Presented at: 2013 ASCO Annual Meeting. J. Clin. Oncol. 31( Suppl.), Abstract 525 (2013).
  • Azim HA, Metzger-Filho O, Azambuja E et al. Pregnancy occurring during or following adjuvant trastuzumab in patients enrolled in the HERA trial (BIG 01-01). Breast Cancer Res. Treat. 133(1), 387–391 (2012).
  • Yu J, Dabbs DJ, Shuai Y, Niemeier LA, Bhargava R. Classical-type invasive lobular carcinoma with HER 2 overexpression: clinical, histologic, and hormone receptor characteristics. Am. J. Clin. Pathol. 136(1), 88–97 (2011).
  • Metzger-Filho O, Procter M, de Azambuja E et al. Magnitude of trastuzumab benefit in patients with HER 2-positive, invasive lobular breast carcinoma: results from the HERA trial. J. Clin. Oncol. 31(16), 1954–1960 (2013).
  • Adami H-O, Malker B, Holmberg L, Persson I, Stone B. The relation between survival and age at diagnosis in breast cancer. N. Engl. J. Med. 315(9), 559–563 (1986).
  • Colleoni M. Role of endocrine responsiveness and adjuvant therapy in very young women (below 35 years) with operable breast cancer and node negative disease. Ann. Oncol. 17(10), 1497–1503 (2006).
  • Partridge AH, Gelber S, Piccart-Gebhart MJ et al. Effect of age on breast cancer outcomes in women with human epidermal growth factor receptor 2-positive breast cancer: results from a herceptin Adjuvant trial. J. Clin. Oncol. 31(21), 2692–2698 (2013).
  • Zabaglo L, Stoss O, Ruschoff J et al. HER2 staining intensity in HER2-positive disease: relationship with FISH amplification and clinical outcome in the HERA trial of adjuvant trastuzumab. Ann. Oncol. ( doi:10.1093/annonc/mdt275) (2013) ( Epub ahead of print).
  • Perez EA, Suman VJ, Davidson NE et al. Sequential versus concurrent trastuzumab in adjuvant chemotherapy for breast cancer. J. Clin. Oncol. 29(34), 4491–4497 (2011).
  • Slamon D, Eiermann W, Robert N et al. Adjuvant trastuzumab in HER2-positive breast cancer. N. Engl. J. Med. 365(14), 1273–1283 (2011).
  • Joensuu H, Bono P, Kataja V et al. Fluorouracil, epirubicin, and cyclophosphamide with either docetaxel or vinorelbine, with or without Trastuzumab, as adjuvant treatments of breast cancer: final results of the finher trial. J. Clin. Oncol. 27(34), 5685–5692 (2009).
  • Spielmann M, Roché H, Delozier T et al. Trastuzumab for patients with axillary-node-positive breast cancer: results of the FNCLCC-PACS 04 trial. J. Clin. Oncol. 27(36), 6129–6134 (2009).
  • Zardavas D, Cameron D, Krop IE, Piccart M. Beyond trastuzumab and lapatinib: new treatment options for HER2-positive breast cancer. Am. Soc. Clin. Oncol. Educ. Book 2013, 2–11 (2013).
  • Zardavas D, Bozovic-Spasojevic I, de Azambuja E. Dual human epidermal growth factor receptor 2 blockade. Curr. Opin. Oncol. 24(6), 612–622 (2012).
  • Blackwell KL, Burstein HJ, Storniolo AM et al. Randomized study of lapatinib alone or in combination with trastuzumab in women with ErbB2-positive, trastuzumab-refractory m etastatic breast cancer. J. Clin. Oncol. 28(7), 1124–1130 (2010).
  • Baselga J, Cortés J, Kim S-B et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N. Engl. J. Med. 366(2), 109–119 (2012).
  • Gianni L, Pienkowski T, Im Y-H et al. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. Lancet Oncol. 13(1), 25–32 (2012).
  • Baselga J, Bradbury I, Eidtmann H et al. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet 379(9816), 633–640 (2012).
  • Tomasello G, de Azambuja E, Dinh P, Snoj N, Piccart-Gebhart M. Jumping higher: is it still possible? The ALTTO trial challenge. Expert Rev. Anticancer. Ther. 8(12), 1883–1890 (2008).
  • Stern HM. Improving treatment of HER2-Positive cancers: opportunities and challenges. Sci. Transl. Med. 4(127), 127rv2 (2012).
  • Ignatiadis M, Rothé F, Chaboteaux C et al. HER2-positive circulating tumor cells in breast cancer. PLoS ONE 6(1), e15624 (2011).
  • Zardavas D, Baselga J, Piccart M. Emerging targeted agents in metastatic breast cancer. Nat. Rev. Clin. Oncol. 10(4), 191–210 (2013).
  • Rodrigues MJ, Peron J, Frénel J-S et al. Benefit of adjuvant trastuzumab-based chemotherapy in T1ab node-negative HER2-overexpressing breast carcinomas: a multicenter retrospective series. Ann. Oncol. 24(4), 916–924 (2013).
  • Goldhirsch A, Winer EP, Coates AS et al. Personalizing the treatment of women with early breast cancer: highlights of the St Gallen International Expert Consensus on the primary therapy of early breast cancer 2013. Ann. Oncol. 24(9), 2206–2223 (2013). http://annonc.oxfordjournals.org/cgi/doi/10.1093/annonc/mdt303 ( Accessed 6 August 2013)

Website

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.