eCase - Therapy for High-Risk HER2+ EBC

CE / CME

Planning Therapy for High-Risk HER2-Positive Early-Stage Breast Cancer: Expert Viewpoint

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: May 12, 2021

Expiration: May 11, 2022

Lee Schwartzberg, MD

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Introduction Neoadjuvant Therapy for Patients With High-Risk HER2+ EBC Adjuvant Therapies for Patients With High-Risk HER2+ EBC Nonanthracycline-Based Chemotherapy Putting It All Together: Strategies for Managing Patients With HER2+ EBC References

References

References

Bellon JR, Guo H, Barry WT, et al. Local–regional recurrence in women with small node-negative, HER2-positive breast cancer: results from a prospective multi-institutional study (the APT trial). Breast Cancer Res Treat. 2019;176:303-310.
Dall P, Koch T, Göhler 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.
Spring LM, Fell G, Arfe A, et al. Pathologic complete response after neoadjuvant chemotherapy and impact on breast cancer recurrence and survival: a comprehensive meta-analysis. Clin Cancer Res. 2020;26:2838-2848.
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.
American Society of Breast Surgeons. Performance and practice guidelines for the use of neoadjuvant systemic therapy in the management of breast cancer. https://www.breastsurgeons.org/docs/statements/Performance-and-Practice-Guidelines-for-the-Use-of-Neoadjuvant-Systemic-Therapy-in-the-Management-of-Breast-Cancer.pdf. Accessed April 27, 2021.
Gianni L, Pienkowski T, Im YH, 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.
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.
Neratinib prescribing information. Los Angeles, CA: Puma Biotechnology; 2020.
Pertuzumab prescribing information. South San Francisco, CA: Genentech; 2020.
Trastuzumab prescribing information. South San Francisco, CA: Genentech; 2018.
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.
Ado-trastuzumab-emtansine prescribing information. South San Francisco, CA: Genentech; 2020.
Piccart M, Proctor, 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. Presented at: 42nd Annual San Antonio Breast Cancer Symposium; December 10-14, 2019. Abstract GS-104.
Piccart M, Procter M, Fumagalli D, et al. Adjuvant pertuzumab and trastuzumab in early HER2-positive breast cancer in the APHINITY trial: 6 years’ follow-up. J Clin Oncol. 2021;Epub ahead of print.
Baselga J, Coleman RE, Cortés J, et al. Advances in the management of HER2-positive early breast cancer. Crit Rev Oncol Hematol. 2017;119:113-122.
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.
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.
Chan A, Moy B, Mansi J, et al. Final efficacy results of neratinib in HER2-positive hormone receptor-positive early-stage breast cancer from the phase III ExteNET trial. Clin Breast Cancer. 2021;21:80-91.e7.
Holmes FA, Moy B, Delaloge, S, et al. Continued efficacy of neratinib in patients with HER2-positive early-stage breast cancer: final overall survival analysis from the randomized phase 3 ExteNET trial. Presented at: 43rd Annual San Antonio Breast Cancer Symposium; December 8-11, 2020. Abstract PD3-03.
Saura C, Oliveira M, Feng YH, et al. Neratinib plus capecitabine versus lapatinib plus capecitabine in HER2-positive metastatic breast cancer previously treated with ≥ 2 HER2-directed regimens: phase III NALA trial. J Clin Oncol. 2020;38:3138-3149.
Lewis Phillips GD, 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.
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. Presented at: 41st Annual San Antonio Breast Cancer Symposium; December 4-10, 2018. Abstract GS1-10.
von Minckwitz G, Huang C-S, Mano MS, et al. Trastuzumab emtansine for residual invasive HER2-positive breast cancer. N Engl J Med. 2019;380:617-628.
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). Presented at: 56th Annual American Society of Clinical Oncology; May 29 - June 2, 2020. Abstract 500.
ClinicalTrials.gov. A study of trastuzumab emtansine (Kadcyla) plus pertuzumab (Perjeta) following anthracyclines in comparison with trastuzumab (Herceptin) plus pertuzumab and a taxane following anthracyclines as adjuvant therapy in participants with operable HER2-positive primary breast cancer. clinicaltrials.gov/ct2/show/NCT01966471. Accessed April 27, 2021.
van Ramshorst MS, van der Voort A, van Werkhoven ED, et al. Neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2 blockade for HER2-positive breast cancer (TRAIN-2): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2018;19:1630-1640.
Van der Voort A, van Romshorst, MS, van Werkhoven, ED, et al. Three-year follow-up of neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2-blockade for HER2-positive breast cancer (TRAIN-2): a randomized phase III trial. Presented at: 56th Annual American Society of Clinical Oncology; May 29 - June 2, 2020. Abstract 501.
Bines J, Procter M, Restuccia E, et al. Incidence and Management of diarrhea with adjuvant pertuzumab and trastuzumab in patients with human epidermal growth factor receptor 2-positive breast cancer. Clin Breast Cancer. 2020;20:174-181.e3.
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;31:1223-1230.
Ruiz-Borrego M, Chan, A, Marx G, et al. Bringing diarrhea under CONTROL: dose escalation reduces neratinib-associated diarrhea and improves tolerability in HER2-positive early-stage breast cancer. Presented at: 43rd Annual San Antonio Breast Cancer Symposium; December 8-11, 2020. Abstract PS13-20.
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). clinicaltrials.gov/ct2/show/NCT03726879. Accessed April 27, 2021.
ClinicalTrials.gov. Neoadjuvant treatment of HER2 positive early high-risk and locally advanced breast cancer (APTneo). clinicaltrials.gov/ct2/show/NCT03595592. Accessed April 27, 2021.
ClinicalTrials.gov. Neoadjuvant study of palbociclib in combination with letrozole and trastuzumab in stage II-III ER+ HER2+ breast cancer (PALTAN). clinicaltrials.gov/ct2/show/NCT02907918. Accessed April 27, 2021.
ClinicalTrials.gov. Neo-adjuvant treatment with palbociclib: effect on Ki67 and apoptosis before, during and after treatment (NA-PHER2). clinicaltrials.gov/ct2/show/NCT02530424. April 27, 2021.
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. Presented at: 55th Annual American Society of Clinical Oncology; May 31 - June 4, 2019. Abstract 527.

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