Advertisement
Review Article| Volume 37, ISSUE 1, P103-115, February 2023

Systemic Therapy for Early- and Late-Stage, Human Epidermal Growth Factor Receptor-2-Positive Breast Cancer

      Keywords

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribers receive full online access to your subscription and archive of back issues up to and including 2002.

      Content published before 2002 is available via pay-per-view purchase only.

      Subscribe:

      Subscribe to Hematology/Oncology Clinics
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Siegel R.L.
        • Miller K.D.
        • Fuchs H.E.
        • et al.
        Cancer Statistics, 2021.
        CA: A Cancer J Clinicians. 2021; 71: 7-33
        • Slamon D.J.
        • Clark G.M.
        • Wong S.G.
        • et al.
        Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene.
        Science. 1987; 235: 177-182
        • Slamon D.J.
        • 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. 2001; 344: 783-792
        • Cortazar P.
        • Zhang L.
        • Untch M.
        • et al.
        Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis.
        The Lancet. 2014; 384: 164-172
        • Spring L.M.
        • 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
        • Yee D.
        • DeMichele A.M.
        • Yau C.
        • et al.
        Association of event-free and distant recurrence-free survival with individual-level pathologic complete response in neoadjuvant treatment of stages 2 and 3 breast cancer: three-year follow-up analysis for the I-SPY2 adaptively randomized clinical trial.
        JAMA Oncol. 2020; 6: 1355-1362
        • DeMichele A.
        • Yee D.
        • Berry D.A.
        • et al.
        The neoadjuvant model is still the future for drug development in breast cancer.
        Clin Cancer Res. 2015; 21: 2911
        • Prowell T.M.
        • Pazdur R.
        Pathological complete response and accelerated drug approval in early breast cancer.
        N Engl J Med. 2012; 366: 2438-2441
        • NCCN
        NCCN Clinical practice guidelines in oncology (NCCN Guidelines®): breast cancer.
        • 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
        • Schneeweiss A.
        • Chia S.
        • Hickish T.
        • et al.
        Long-term efficacy analysis of the randomised, phase II TRYPHAENA cardiac safety study: Evaluating pertuzumab and trastuzumab plus standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer.
        Eur J Cancer. 2018; 89: 27-35
        • Schneeweiss A.
        • Ross G.
        • Ratnayake J.
        • 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
        • van Ramshorst M.S.
        • van der Voort A.
        • van Werkhoven E.D.
        • 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
        • Tan T.C.
        • Neilan T.G.
        • Francis S.
        • et al.
        Anthracycline-induced cardiomyopathy in adults.
        in: Prakash Y.S. Comprehensive physiology. John Wiley & Sons, Inc., 2011
        • Petrelli F.
        • Borgonovo K.
        • Cabiddu M.
        • et al.
        Mortality, leukemic risk, and cardiovascular toxicity of adjuvant anthracycline and taxane chemotherapy in breast cancer: a meta-analysis.
        Breast Cancer Res Treat. 2012; 135: 335-346
        • Tallman M.S.
        • Gray R.
        • Bennett J.M.
        • et al.
        Leukemogenic potential of adjuvant chemotherapy for early-stage breast cancer: the Eastern Cooperative Oncology Group experience.
        J Clin Oncol. 1995; 13: 1557-1563
        • von Minckwitz G.
        • Huang C.S.
        • Mano M.S.
        • et al.
        Trastuzumab emtansine for residual invasive HER2-positive breast cancer.
        N Engl J Med. 2019; 380: 617-628
        • Mamounas E.P.
        • Untch M.
        • Mano M.S.
        • et al.
        Adjuvant T-DM1 versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer: subgroup analyses from KATHERINE.
        Ann Oncol. 2021; 32: 1005-1014
        • Loibl S.H.C.
        • Mano M.S.
        • Mamounas T.P.
        • et al.
        Adjuvant trastuzumab emtansine (T-DM1) vs trastuzumab (T) in patients (pts) with residual invasive disease after neoadjuvant therapy for HER2+ breast cancer: Subgroup analysis from KATHERINE.
        Ann Oncol. 2020; 31: S48-S53
        • 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
        • 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 e87
        • Barcenas C.H.
        • Hurvitz S.A.
        • Di Palma J.A.
        • et al.
        Improved tolerability of neratinib in patients with HER2-positive early-stage breast cancer: the CONTROL trial.
        Ann Oncol. 2020; 31: 1223-1230
        • Gonzalez-Angulo A.M.
        • Litton J.K.
        • Broglio K.R.
        • 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
        • Chia S.
        • Norris B.
        • Speers C.
        • et al.
        Human epidermal growth factor receptor 2 overexpression as a prognostic factor in a large tissue microarray series of node-negative breast cancers.
        J Clin Oncol. 2008; 26: 5697-5704
        • Vaz-Luis I.
        • Ottesen R.A.
        • Hughes M.E.
        • et al.
        Outcomes by tumor subtype and treatment pattern in women with small, node-negative breast cancer: a multi-institutional study.
        J Clin Oncol. 2014; 32: 2142-2150
        • Howlader N.
        • Altekruse S.F.
        • Li C.I.
        • et al.
        US incidence of breast cancer subtypes defined by joint hormone receptor and HER2 status.
        J Natl Cancer Inst. 2014; 106
        • Tolaney S.M.
        • 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
        • Tolaney S.M.
        • Tayob N.
        • Dang C.
        • et al.
        Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial.
        J Clin Oncol. 2021; 39: 2375-2385
        • Waisberg F.
        • Enrico D.
        • Angel M.
        • et al.
        Cancer Treatment Adaptations in the COVID-19 Era.
        JCO Oncol Pract. 2020; 16: 305-307
        • Romond E.H.
        • Perez E.A.
        • Bryant J.
        • et al.
        Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer.
        N Engl J Med. 2005; 353: 1673-1684
        • Piccart-Gebhart M.J.
        • Procter M.
        • Leyland-Jones B.
        • et al.
        Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer.
        N Engl J Med. 2005; 353: 1659-1672
        • Slamon D.
        Phase III randomized trial comparing doxorubicin and cyclophosphamide followed by docetaxel (AC-> T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab (AC-> TH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2 positive early breast cancer patients: BCIRG 006 study.
        Breast Cancer Res Treat. 2005; 94: S5
        • Conte P.
        • Frassoldati A.
        • Bisagni G.
        • et al.
        Nine weeks versus 1 year adjuvant trastuzumab in combination with chemotherapy: final results of the phase III randomized Short-HER study.
        Ann Oncol. 2018; 29: 2328-2333
        • Joensuu H.
        • Fraser J.
        • Wildiers H.
        • et al.
        Effect of adjuvant trastuzumab for a duration of 9 weeks vs 1 year with concomitant chemotherapy for early human epidermal growth factor receptor 2–positive breast cancer: the SOLD randomized clinical trial.
        JAMA Oncol. 2018; 4: 1199-1206
        • Pivot X.
        • Romieu G.
        • Debled M.
        • et al.
        6 months versus 12 months of adjuvant trastuzumab in early breast cancer (PHARE): final analysis of a multicentre, open-label, phase 3 randomised trial.
        Lancet. 2019; 393: 2591-2598
        • Earl H.M.
        • Hiller L.
        • Vallier A.-L.
        • et al.
        6 versus 12 months of adjuvant trastuzumab for HER2-positive early breast cancer (PERSEPHONE): 4-year disease-free survival results of a randomised phase 3 non-inferiority trial.
        Lancet. 2019; 393: 2599-2612
        • Swain S.M.
        • Baselga J.
        • Kim S.-B.
        • et al.
        Pertuzumab, Trastuzumab, and Docetaxel in HER2-Positive Metastatic Breast Cancer.
        N Engl J Med. 2015; 372: 724-734
        • Johnston S.
        • Pippen Jr., J.
        • Pivot X.
        • et al.
        Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer.
        J Clin Oncol. 2009; 27: 5538-5546
        • Kaufman B.
        • Mackey J.R.
        • Clemens M.R.
        • et al.
        Trastuzumab Plus Anastrozole Versus Anastrozole Alone for the Treatment of Postmenopausal Women With Human Epidermal Growth Factor Receptor 2–Positive, Hormone Receptor–Positive Metastatic Breast Cancer: Results From the Randomized Phase III TAnDEM Study.
        J Clin Oncol. 2009; 27: 5529-5537
        • Johnston S.R.D.
        • Hegg R.
        • Im S.A.
        • et al.
        Phase III, randomized study of dual human epidermal growth factor receptor 2 (HER2) blockade with lapatinib plus trastuzumab in combination with an aromatase inhibitor in postmenopausal women with HER2-positive, hormone receptor-positive metastatic breast cancer: updated results of ALTERNATIVE.
        J Clin Oncol. 2021; 39: 79-89
        • Rimawi M.
        • Ferrero J.-M.
        • Haba-Rodriguez Jdl
        • et al.
        First-Line Trastuzumab plus an aromatase inhibitor, with or without pertuzumab, in human epidermal growth factor receptor 2–positive and hormone receptor–positive metastatic or locally advanced breast cancer (PERTAIN): a randomized, open-label phase II trial.
        J Clin Oncol. 2018; 36: 2826-2835
        • Hua X.
        • Bi X.-W.
        • Zhao J.-L.
        • et al.
        Trastuzumab Plus endocrine therapy or chemotherapy as first-line treatment for patients with hormone receptor–positive and HER2-positive metastatic breast cancer (SYSUCC-002).
        Clin Cancer Res. 2021; 28: 637-645
        • Verma S.
        • Miles D.
        • Gianni L.
        • et al.
        Trastuzumab Emtansine for HER2-Positive Advanced Breast Cancer.
        N Engl J Med. 2012; 367: 1783-1791
        • Ogitani Y.
        • Hagihara K.
        • Oitate M.
        • et al.
        Bystander killing effect of DS-8201a, a novel anti-human epidermal growth factor receptor 2 antibody-drug conjugate, in tumors with human epidermal growth factor receptor 2 heterogeneity.
        Cancer Sci. 2016; 107: 1039-1046
        • Modi S.
        • Park H.
        • Murthy R.K.
        • et al.
        Antitumor activity and safety of trastuzumab deruxtecan in patients with HER2-Low–expressing advanced breast cancer: results from a phase Ib study.
        J Clin Oncol. 2020; 38: 1887-1896
        • Modi S.
        • Saura C.
        • Yamashita T.
        • et al.
        Trastuzumab deruxtecan in previously treated HER2-positive breast cancer.
        N Engl J Med. 2020; 382: 610-621
        • Cortés J.
        • Kim S.-B.
        • Chung W.-P.
        • et al.
        Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer.
        N Engl J Med. 2022; 386: 1143-1154
        • Powell C.
        • Modi S.
        • Iwata H.
        • et al.
        92O - Analysis of study drug-related interstitial lung disease (ILD) in patients (pts) with HER2+ metastatic breast cancer (mBC) treated with trastuzumab deruxtecan (T-DXd).
        Ann Oncol. 2021; 32: S60-S78
        • Swain S.M.
        • Nishino M.
        • Lancaster L.H.
        • et al.
        Multidisciplinary clinical guidance on trastuzumab deruxtecan (T-DXd)–related interstitial lung disease/pneumonitis—Focus on proactive monitoring, diagnosis, and management.
        Cancer Treat Rev. 2022; 106: 102378
        • Lee P.
        • Anderson D.
        • Bouhana K.
        • et al.
        In Vivo Activity of ARRY-380, a Potent, Small Molecule Inhibitor of ErbB2 in Combination with Trastuzumab, Docetaxel or Bevacizumab.
        Cancer Res. 2009; 69: 5104
        • Murthy R.K.
        • Loi S.
        • Okines A.
        • et al.
        Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer.
        N Engl J Med. 2019; 382: 597-609
        • Saura C.
        • Oliveira M.
        • Feng Y.-H.
        • 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
        • Geyer C.E.
        • Forster J.
        • Lindquist D.
        • et al.
        Lapatinib plus Capecitabine for HER2-Positive Advanced Breast Cancer.
        N Engl J Med. 2006; 355: 2733-2743
        • Rugo H.S.
        • Im S.-A.
        • Cardoso F.
        • et al.
        Efficacy of Margetuximab vs Trastuzumab in Patients With Pretreated ERBB2-Positive Advanced Breast Cancer: A Phase 3 Randomized Clinical Trial.
        JAMA Oncol. 2021; 7: 573-584
        • Rugo H.
        • Im S.-A.
        • Cardoso F.
        • et al.
        Abstract PD8-01: Phase 3 SOPHIA study of margetuximab (M) + chemotherapy (CTX) vs trastuzumab (T) + CTX in patients (pts) with HER2+ metastatic breast cancer (MBC) after prior anti-HER2 therapies: Final overall survival (OS) analysis.
        Cancer Res. 2022; 82 (PD8-01-PD08-01)
        • Bedard P.L.
        • Im S.-A.
        • Elimova E.
        • et al.
        Abstract P2-13-07: Zanidatamab (ZW25), a HER2-targeted bispecific antibody, in combination with chemotherapy (chemo) for HER2-positive breast cancer (BC): Results from a phase 1 study.
        Cancer Res. 2022; 82 (P2-13-07-P12-13-07)
        • Zhang X.
        • Huang A.C.
        • Chen F.
        • et al.
        Novel development strategies and challenges for anti-Her2 antibody-drug conjugates.
        Antib Ther. 2022; 5: 18-29
        • Tolaney S.M.
        • Wardley A.M.
        • Zambelli S.
        • et al.
        Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, open-label, phase 2 trial.
        Lancet Oncol. 2020; 21: 763-775
        • Emens L.A.
        • Esteva F.J.
        • Beresford M.
        • et al.
        Trastuzumab emtansine plus atezolizumab versus trastuzumab emtansine plus placebo in previously treated, HER2-positive advanced breast cancer (KATE2): a phase 2, multicentre, randomised, double-blind trial.
        Lancet Oncol. 2020; 21: 1283-1295
        • Collier P.
        • Hussain M.
        • Popovic Z.B.
        • et al.
        Cardiac surveillance for anti-HER2 chemotherapy.
        Cleve Clin J Med. 2021; 88: 110-116
        • Suter T.M.
        • Procter M.
        • Van Veldhuisen D.J.
        • et al.
        Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial.
        J Clin Oncol. 2007; 25: 3859-3865