HER2+ EBC: Evolution

CE / CME

The Evolving Therapeutic Landscape for HER2-Positive Early-Stage Breast Cancer

Pharmacists: 1.00 contact hour (0.1 CEUs)

Physicians: Maximum of 1.00 AMA PRA Category 1 Credit

Nurses: 1.00 Nursing contact hour

Released: August 10, 2020

Expiration: August 09, 2021

Lee Schwartzberg
Lee Schwartzberg, MD

Activity

Progress
1
Course Completed

  1. Sørlie T, Tibshirani R, Parker J, et al. Repeated observation of breast tumor subtypes in independent gene expression data sets. Proc Natl Acad Sci U S A. 2003;100:8418-8423.
  2. Piccart-Gebhart MJ, Procter M, Leyland-Jones B, et al. Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med. 2005;353:1659-1672.
  3. 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. 2007;369:29-36. 
  4. 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. 2011;12:236-244.
  5. Goldhirsch A, Piccart-Gebhart MJ, Procter M, et al. HERA TRIAL: 2 years versus 1 year of trastuzumab after adjuvant chemotherapy in women with HER2-positive early breast cancer at 8 years of median follow up. Program and abstracts of the 35th Annual San Antonio Breast Cancer Symposium; December 4-8, 2012; San Antonio, Texas. Abstract S5-2.
  6. Cameron D, Piccart-Gebhart MJ, Gelber RD, et al. 11 years' follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive early breast cancer: final analysis of the HERceptin Adjuvant (HERA) trial. Lancet. 2017;389:1195-1205.
  7. Romond EH, Perez EA, Bryant J, et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. N Engl J Med. 2005;353:1673-1684.
  8. Perez EA, Romond EH, Suman VJ, et al. Four-year follow-up of trastuzumab plus adjuvant chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer: joint analysis of data from NCCTG N9831 and NSABP B-31. J Clin Oncol. 2011;29:3366-3373.
  9. Romond E, Suman VJ, Jeong J-H, et al. Trastuzumab plus adjuvant chemotherapy for HER2-positive breast cancer: final planned joint analysis of overall survival (OS) from NSABP B-31 and NCCTG N9831. Program and abstracts of the 35th Annual San Antonio Breast Cancer Symposium; December 4-8, 2012; San Antonio, Texas. Abstract S5-5. 9.
  10. Slamon D, Eiermann W, Robert N, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365:1273-1283.
  11. Slamon DJ, Eiermann W, Robert NJ, et al. Ten year follow-up of BCIRG-006 comparing doxorubicin plus cyclophosphamide followed by docetaxel (AC→T) with doxorubicin plus cyclophosphamide followed by docetaxel and trastuzumab (AC→TH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2+ early breast cancer. Program and abstracts of the 38th Annual San Antonio Breast Cancer Symposium; December 8-12, 2015; San Antonio, Texas. Abstract S5-04.
  12. Dall P, Koch T, Gohler T, et al. Trastuzumab in human epidermal growth factor receptor 2-positive early breast cancer: results of a prospective, noninterventional study on routine treatment between 2006 and 2012 in Germany. Oncologist. 2017;22:131-138.
  13. Gonzalez-Angulo AM, Litton JK, Broglio KR, et al. High risk of recurrence for patients with breast cancer who have human epidermal growth factor receptor 2-positive, node-negative tumors 1 cm or smaller. J Clin Oncol. 2009;27:5700-5706.
  14. Tolaney SM, Guo H, Pernas S, et al. Seven-year follow-up analysis of adjuvant paclitaxel and trastuzumab trial for node-negative, human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol. 2019;37:1868-1875.
  15. Ado-trastuzumab emtansine [package insert]. South San Francisco, CA: Genentech; 2019.
  16. Lewis Phillips D, Li G, Dugger DL, et al. Targeting HER2-positive breast cancer with trastuzumab-DM1, an antibody-cytotoxic drug conjugate. Cancer Res. 2008;68:9280-9290.
  17. Tolaney SM, Trippa L, Barry W, et al. TBCRC 033: a randomized phase II study of adjuvant trastuzumab emtansine (T-DM1) vs paclitaxel (T) in combination with trastuzumab (H) for stage I HER2-positive breast cancer (BC) (ATEMPT). Program and abstracts of the 42nd Annual San Antonio Breast Cancer Symposium; December 10-14, 2019; San Antonio, Texas. Abstract GS1-05.
  18. Gralow JR, Burstein HJ, Wood W, et al. Preoperative therapy in invasive breast cancer: pathologic assessment and systemic therapy issues in operable disease. J Clin Oncol. 2008;26:814-819.
  19. Kaufmann M, Hortobagya GN, Goldhirsch A, et al. Recommendations from an international expert panel on the use of neoadjuvant (primary) systemic treatment of operable breast cancer: an update. J Clin Oncol. 2006;24:1940-1949.
  20. Cortazar P, Zhang L, Untch M, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis. Lancet 2014;384:164-172.
  21. Cardoso F, Kyriakides S, Ohno S, et al. Early breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019;30:1194-1220.
  22. 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. 2012;13:25-32.
  23. Schneeweiss A, Chia S, Hickish T, et al. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol. 2013;24:2278-2284.
  24. Neratinib [package insert]. Los Angeles, CA: Puma Biotechnology, Inc; 2020.
  25. Pertuzumab [package insert]. South San Francisco, CA: Genentech; 2019.  
  26. von Minckwitz G, Procter M, de Azambuja E, et al. Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer. N Engl J Med. 2017;377:122-131.
  27. Hudis CA, Barlow WE, Costantino JP, et al. Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system. J Clin Oncol. 2007;25:2127-2132.
  28. Piccart M, Procter M, Fumagalli D, et al. Interim overall survival analysis of APHINITY (BIG 4-11): A randomized multicenter, double-blind, placebo-controlled trial comparing chemotherapy plus trastuzumab plus pertuzumab versus chemotherapy plus trastuzumab plus placebo as adjuvant therapy in patients with operable HER2-positive early breast cancer. Program and abstracts of the 42nd Annual San Antonio Breast Cancer Symposium; December 10-14, 2019; San Antonio, Texas. Abstract GS1-04.
  29. Baselga J, Coleman RE, Cortes J, Janni W. Advances in the management of HER2-positive early breast cancer. Crit Rev Oncol Hematol. 2017;119:113-122.
  30. Chan A, Delaloge S, Holmes FA, et al. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016;17:367-377.
  31. Martin M, Holmes FA, Ejlertsen B, et al. Neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): 5-year analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2017;18:1688-1700.
  32. Geyer CE, Huang C-S, Mano MS, et al. Phase III study of trastuzumab emtansine (T-DM1) vs trastuzumab as adjuvant therapy in patients with HER2-positive early breast cancer with residual invasive disease after neoadjuvant chemotherapy and HER2-targeted therapy including trastuzumab: primary results from KATHERINE. Program and abstracts of the 41st Annual San Antonio Breast Cancer Symposium; December 4-8, 2018; San Antonio, Texas. Abstract GS1-10.
  33. von Minckwitz G, Huang CS, Mano MS, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med. 2019;380:617-628.
  34. Harbeck N, Im S-A, Barrios CH, et al. Primary analysis of KAITLIN: a phase III study of trastuzumab emtansine (T-DM1) + pertuzumab versus trastuzumab + pertuzumab + taxane, after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer (EBC). Program and abstracts of the 2020 Annual Meeting of the Americn Society of Clinical Oncology; May 29-31, 2020; Virtual Meeting. Abstract 500.
  35. Barcenas CH, Hurvitz SA, Di Palma JA, et al. Improved tolerability of neratinib in patients with HER2-positive early-stage breast cancer: the CONTROL trial. Ann Oncol. 2020;[Epub ahead of print].
  36. Chan A, Hurvitz SA, Marx G, et al. Effect of prophylaxis or neratinib dose escalation on neratinib-associated diarrhea and tolerability in patients with HER2-positive early-stage breast cancer: phase II CONTROL trial. Program and abstracts of the 42nd Annual San Antonio Breast Cancer Symposium; December 10-14, 2019; San Antonio, Texas. Abstract P5-14-03. 
  37. Ibrahim E, Tripathy D, Wilkinson M, et al. Effects of adding budesonide or colestipol to loperamide prophylaxis on neratinib-associated diarrhea in patients (pts) with HER2+ early-stage breast cancer (eBC): the CONTROL trial. Program and abstracts of the 2017 Annual Meeting of the Americn Association for Cancer Research; April 1-5, 2017; Washington, D.C. Abstract CT128.
  38. ClinicalTrials.gov. A study to evaluate the efficacy and safety of atezolizumab or placebo in combination with neoadjuvant doxorubicin + cyclophosphamide followed by paclitaxel + trastuzumab + pertuzumab in early Her2-positive breast cancer (IMpassion050). Available at: https://clinicaltrials.gov/ct2/show/NCT03726879. Accessed July 26, 2020.
  39. ClinicalTrials.gov. Neoadjuvant treatment of HER2 positive early high-risk and locally advanced breast cancer (APTneo). Available at: https://clinicaltrials.gov/ct2/show/NCT03595592. Accessed July 26, 2020.
  40. ClinicalTrials.gov. Neoadjuvant study of palbociclib in combination with letrozole and trastuzumab in stage II-III ER+ HER2+ breast cancer (PALTAN). Available at: https://clinicaltrials.gov/ct2/show/NCT02907918. Accessed July 26, 2020.
  41. ClinicalTrials.gov. Neo-adjuvant treatment with palbociclib: effect on Ki67 and apoptosis before, during and after treatment (NA-PHER2). Available at: https://clinicaltrials.gov/ct2/show/NCT02530424. Accessed July 26, 2020.
  42. Gianni L, Colleoni M, Bisagni G, et al. Ki67 during and after neoadjuvant trastuzumab, pertuzumab and palbociclib plus or minus fulvestrant in HER2 and ER-positive breast cancer: The NA-PHER2 Michelangelo study. Program and abstracts of the 2019 Annual Meeting of the Americn Society of Clinical Oncology; May 31 - June 4; Chicago, Illinois. Abstract 527.