Pertuzumab and breast cancer: another piece in the anti-HER2 puzzle

References

• Ross JS, Slodkowska EA, Symmans WF, et al. The HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicine. Oncologist. 2009;14(4):320–368.
   PubMed Web of Science ®Google Scholar
• Wolff AC, Hammond MEH, Hicks DG, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol. 2013;31(31):3997–4013.
   PubMed Web of Science ®Google Scholar
• Bonotto M, Gerratana L, Poletto E, et al. Measures of outcome in metastatic breast cancer: insights from a real-world scenario. Oncologist. 2014;19(6):608–615.
   PubMed Web of Science ®Google Scholar
• 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. 2001;344(11):783–792.
   PubMed Web of Science ®Google Scholar
• Slamon D, Eiermann W, Robert N, et al. Adjuvant trastuzumab in HER2-positive breast cancer. N Engl J Med. 2011;365(14):1273–1283.
   PubMed Web of Science ®Google Scholar
• Abramson V, Arteaga CL. New strategies in HER2-overexpressing breast cancer: many combinations of targeted drugs available. Clin Cancer Res. 2011;17(5):952–958.
   PubMed Web of Science ®Google Scholar
• Cameron D, Casey M, Oliva C, et al. Lapatinib plus capecitabine in women with HER-2-positive advanced breast cancer: final survival analysis of a phase III randomized trial. Oncologist. 2010;15(9):924–934.
   PubMed Web of Science ®Google Scholar
• 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(25):3366–3373.
   PubMed Web of Science ®Google Scholar
• Baselga J, Cortés J, Kim S-B, et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med. 2012;366(2):109–119.
   PubMed Web of Science ®Google Scholar
• Verma S, Miles D, Gianni L, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012;367(19):1783–1791.
   PubMed Web of Science ®Google Scholar
• Puglisi F, Fontanella C, Amoroso V, et al. Current challenges in HER2-positive breast cancer. Crit Rev Oncol Hematol. 2016;98:211–221.
   PubMed Web of Science ®Google Scholar
• Guan Z, Xu B, DeSilvio ML, et al. Randomized Trial of lapatinib versus placebo added to paclitaxel in the treatment of human epidermal growth factor receptor 2-overexpressing metastatic breast cancer. J Clin Oncol. 2013;31(16):1947–1953.
   PubMed Web of Science ®Google Scholar
• Piccart-Gebhart MJ, Holmes AP, Baselga J. et al., First results from the phase III ALTTO trial (BIG 2-06; NCCTG [Alliance] N063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone (T), their sequence (T→L), or their combination (T+L) in the adjuvant treatment of HER2-positive early breast cancer (EBC). J Clin Oncol. 2014;32: 5s(suppl;abstr LBA4). Available from: http://meetinglibrary.asco.org/content/128258-144
   Google Scholar
• Krop IE, Kim S-B, González-Martín A, et al. Trastuzumab emtansine versus treatment of physician’s choice for pretreated HER2-positive advanced breast cancer (TH3RESA): a randomised, open-label, phase 3 trial. Lancet Oncol. 2014;15(7):689–699.
   PubMed Web of Science ®Google Scholar
• Nahta R, Hung M-C, Esteva FJ. The HER-2-targeting antibodies trastuzumab and pertuzumab synergistically inhibit the survival of breast cancer cells. Cancer Res. 2004;64(7):2343–2346.
   PubMed Web of Science ®Google Scholar
• Blumenthal GM, Scher NS, Cortazar P, et al. First FDA approval of dual anti-HER2 regimen: pertuzumab in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer. Clin Cancer Res. 2013;19(18):4911–4916.
   PubMed Web of Science ®Google Scholar
• Amiri-Kordestani L, Wedam S, Zhang L, et al. First FDA approval of neoadjuvant therapy for breast cancer: pertuzumab for the treatment of patients with HER2-positive breast cancer. Clin Cancer Res. 2014;20(21):5359–5364.
   PubMed Web of Science ®Google Scholar
• Yarden Y. The EGFR family and its ligands in human cancer. signalling mechanisms and therapeutic opportunities. Eur J Cancer. 2001;37(Suppl 4):S3–S8.
   PubMed Web of Science ®Google Scholar
• Yarden Y, Sliwkowski MX. Untangling the ErbB signalling network. Nat Rev Mol Cell Biol. 2001;2(2):127–137.
   PubMed Web of Science ®Google Scholar
• Ogiso H, Ishitani R, Nureki O, et al. Crystal structure of the complex of human epidermal growth factor and receptor extracellular domains. Cell. 2002;110(6):775–787.
   PubMed Web of Science ®Google Scholar
• Garrett TPJ, McKern NM, Lou M, et al. The crystal structure of a truncated ErbB2 ectodomain reveals an active conformation, poised to interact with other ErbB receptors. Mol Cell. 2003;11(2):495–505.
   PubMed Web of Science ®Google Scholar
• Hu S, Sun Y, Meng Y, et al. Molecular architecture of the ErbB2 extracellular domain homodimer. Oncotarget. 2015;6(3):1695–1706.
   PubMed Web of Science ®Google Scholar
• Franklin MC, Carey KD, Vajdos FF, et al. Insights into ErbB signaling from the structure of the ErbB2-pertuzumab complex. Cancer Cell. 2004;5(4):317–328.
   PubMed Web of Science ®Google Scholar
• Yarden Y, Pines G. The ERBB network: at last, cancer therapy meets systems biology. Nat Rev Cancer. 2012;12(8):553–563.
   PubMed Web of Science ®Google Scholar
• Cho H-S, Mason K, Ramyar KX, et al. Structure of the extracellular region of HER2 alone and in complex with the Herceptin Fab. Nature. 2003;421(6924):756–760.
   PubMed Web of Science ®Google Scholar
• Clynes RA, Towers TL, Presta LG, et al. Inhibitory Fc receptors modulate in vivo cytotoxicity against tumor targets. Nat Med. 2000;6(4):443–446.
   PubMed Web of Science ®Google Scholar
• Molina MA, Codony-Servat J, Albanell J, et al. Trastuzumab (herceptin), a humanized anti-HER2 receptor monoclonal antibody, inhibits basal and activated HER2 ectodomain cleavage in breast cancer cells. Cancer Res. 2001;61(12):4744–4749.
   PubMed Web of Science ®Google Scholar
• El-Sahwi K, Bellone S, Cocco E, et al. In vitro activity of pertuzumab in combination with trastuzumab in uterine serous papillary adenocarcinoma. Br J Cancer. 2009;102(1):134–143.
   PubMed Web of Science ®Google Scholar
• Scheuer W, Friess T, Burtscher H, et al. Strongly enhanced antitumor activity of trastuzumab and pertuzumab combination treatment on HER2-positive human xenograft tumor models. Cancer Res. 2009;69(24):9330–9336.
   PubMed Web of Science ®Google Scholar
• Bianchini G, Pusztai L, Pienkowski T, et al. Immune modulation of pathologic complete response after neoadjuvant HER2-directed therapies in the NeoSphere trial. Ann Oncol. 2015;26(12):2429–2436.
   PubMed Web of Science ®Google Scholar
• Gianni L, Eiermann W, Semiglazov V, et al. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet. 2010;375(9712):377–384.
   PubMed Web of Science ®Google Scholar
• Agus DB. Phase I clinical study of pertuzumab, a novel HER dimerization inhibitor, in patients with advanced cancer. J Clin Oncol. 2005;23(11):2534–2543.
   PubMed Web of Science ®Google Scholar
• 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(1):25–32.
   PubMed Web of Science ®Google Scholar
• 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(9):2278–2284.
   PubMed Web of Science ®Google Scholar
• Schneeweiss A, Chia S, Hegg R, et al. Evaluating the predictive value of biomarkers for efficacy outcomes in response to pertuzumab- and trastuzumab-based therapy: an exploratory analysis of the TRYPHAENA study. Breast Cancer Res. 2014;16(4):R73.
   PubMed Web of Science ®Google Scholar
• Puglisi F, Minisini AM, De Angelis C, et al. Overcoming treatment resistance in HER2-positive breast cancer: potential strategies. Drugs. 2012;72(9):1175–1193.
   PubMed Web of Science ®Google Scholar
• Phase 2 study of standard chemotherapy with trastuzumab, plus or minus pertuzumab, for pre-treated metastatic breast cancer - full text view - ClinicalTrials.gov [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT02229149?term=pertuzumab+breast&rank=2
   Google Scholar
• A randomized, open-label phase III trial to evaluate the efficacy and safety of pertuzumab retreatment in previously pertuzumab, trastuzuamb and chemotherapy treated HER2-positive metastatic locally advanced and metastatic breast cancer(Study of Perjeta Re-treatment for Clinical Outcomes) - full text view - ClinicalTrials.gov [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT02514681?term=pertuzumab+metastatic+breast&rank=8
   Google Scholar
• A study of pertuzumab in combination with trastuzumab plus an aromatase inhibitor in patients with hormone receptor-positive, metastatic HER2-positive breast cancer [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT01491737
   Google Scholar
• A study of pertuzumab in combination with herceptin (trastuzumab) and vinorelbine in first line in patients with metastatic or locally advanced HER2-positive breast [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT01565083
   Google Scholar
• Elderly metastatic breast cancer: pertuzumab-herceptin vs pertuzumab-herceptin-metronomic chemotherapy, followed by T-DM1 - full text view - ClinicalTrials.gov [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT01597414?term=NCT01597414&rank=1
   Google Scholar
• Krop IE, Modi S, LoRusso PM, et al. Phase 1b/2a study of trastuzumab emtansine (T-DM1), paclitaxel, and pertuzumab in HER2-positive metastatic breast cancer. Breast Cancer Res. 2016;18(1):34.
   PubMed Web of Science ®Google Scholar
• Safety and pharmacokinetics of atezolizumab in combination with trastuzumab emtansine or with trastuzumab and pertuzumab in participants with HER2-positive breast cancer - full text view - ClinicalTrials.gov [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT02605915
   Google Scholar
• Phase Ib dose-escalation trial of taselisib (GDC-0032) in combination with anti-HER2 therapies in participants with advanced HER2+ breast cancer - full text view - ClinicalTrials.gov [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT02390427
   Google Scholar
• Baselga J, Cortés J, Im S-A, et al. Biomarker analyses in CLEOPATRA: a phase III, placebo-controlled study of pertuzumab in human epidermal growth factor receptor 2-positive, first-line metastatic breast cancer. J Clin Oncol. 2014;32(33):3753–3761.
   PubMed Web of Science ®Google Scholar
• Swain SM, Baselga J, Kim S-B, et al. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015;372(8):724–734.
   PubMed Web of Science ®Google Scholar
• A study of pertuzumab in combination with herceptin (trastuzumab) and a taxane in first-line treatment in patients with HER2-positive advanced breast cancer (PERUSE) [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT01572038
   Google Scholar
• Bachelot TD, Ciruelos E, Peretz-Yablonski T. et al., First-line pertuzumab (P), trastuzumab (H), and taxane therapy for HER2-positive locally recurrent/metastatic breast cancer (LR/mBC): Interim safety results (N=704) from PERUSE. J Clin Oncol. 2014;32: 5s(suppl; abstr 548^). Available from: http://meetinglibrary.asco.org/content/128385-144
   Google Scholar
• Miles D, Fung A, Yoo B, et al. Effect of docetaxel duration on clinical outcomes: Results from the phase III trial CLEOPATRA. Cancer Res. 2016;76(4Supplement): P4–P14–27–P4–14–27.
   PubMed Web of Science ®Google Scholar
• Miller KD, Diéras V, Harbeck N, et al. Phase IIa trial of trastuzumab emtansine with pertuzumab for patients with human epidermal growth factor receptor 2-positive, locally advanced, or metastatic breast cancer. J Clin Oncol. 2014;32(14):1437–1444.
   PubMed Web of Science ®Google Scholar
• Ellis PA, Barrios CH, Eiermann W, et al. Phase III, randomized study of trastuzumab emtansine (T-DM1) ± pertuzumab (P) vs trastuzumab + taxane (HT) for first-line treatment of HER2-positive MBC: Primary results from the MARIANNE study. J Clin Oncol. 2015;33. Available from: http://meetinglibrary.asco.org/content/147990-156
   Google Scholar
• Barrios CH, Cella D, Martin M, et al. Patient-reported outcomes (PROs) from MARIANNE: A phase III study of trastuzumab emtansine (T-DM1) +/- pertuzumab (P) vs trastuzumab + taxane (HT) for HER2-positive advanced breast cancer. J Clin Oncol. 2016;34. Available from: http://meetinglibrary.asco.org/content/166295-176
   Google Scholar
• Giordano SH, Temin S, Kirshner JJ, et al. Systemic therapy for patients with advanced human epidermal growth factor receptor 2-positive breast cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014;32(19):2078–2099.
   PubMed Web of Science ®Google Scholar
• Baselga J, Gelmon KA, Verma S, et al. Phase II trial of pertuzumab and trastuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer that progressed during prior trastuzumab therapy. J Clin Oncol. 2010;28(7):1138–1144.
   PubMed Web of Science ®Google Scholar
• Portera CC, Walshe JM, Rosing DR, et al. Cardiac toxicity and efficacy of trastuzumab combined with pertuzumab in patients with [corrected] human epidermal growth factor receptor 2-positive metastatic breast cancer. Clin Cancer Res. 2008;14(9):2710–2716.
   PubMed Web of Science ®Google Scholar
• Urruticoechea A, Rizwanullah M, Im S-A, et al. PHEREXA: A phase III study of trastuzumab (H) + capecitabine (X) ± pertuzumab (P) for patients (pts) who progressed during/after one line of H-based therapy in the HER2-positive metastatic breast cancer (MBC) setting. J Clin Oncol. 2016;34. Available from: http://meetinglibrary.asco.org/content/162688-176
   Google Scholar
• A study of pertuzumab in addition to chemotherapy and trastuzumab as adjuvant therapy in participants with human epidermal growth receptor 2 (HER2)-positive primary breast cancer [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT01358877
   Google Scholar
• Adjuvant trastuzumab, pertuzumab plus docetaxel in the treatment of early HER2-positive breast cancer [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT02625441
   Google Scholar
• A study of kadcyla (trastuzumab emtansine) plus perjeta (pertuzumab) following anthracyclines in comparison with herceptin (trastuzumab) plus perjeta and a taxane following anthracyclines as adjuvant therapy in patients with operable HER2-positive primary breast cancer [Internet]. Available from: https://clinicaltrials.gov/ct2/show/NCT01966471?term=NCT01966471&rank=1
   Google Scholar
• Robert N, Goertz H-P, Asmar L, et al. Pertuzumab (P) use in first-line HER2-positive metastatic breast cancer (mBC) in US community oncology practices: Treatment patterns and outcomes. Cancer Res. 2016;76(4Supplement): P4–P14– 13–P4–14–13.
   PubMed Web of Science ®Google Scholar
• Gianni L, Pienkowski T, Im Y-H, et al. 5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial. Lancet Oncol. 2016;17(6):791–800.
   PubMed Web of Science ®Google Scholar
• Swain SM, Ewer MS, Cortés J, et al. Cardiac tolerability of pertuzumab plus trastuzumab plus docetaxel in patients with HER2-positive metastatic breast cancer in CLEOPATRA: a randomized, double-blind, placebo-controlled phase III study. Oncologist. 2013;18(3):257–264.
   PubMed Web of Science ®Google Scholar
• Arteaga CL, Sliwkowski MX, Osborne CK, et al. Treatment of HER2-positive breast cancer: current status and future perspectives. Nat Rev Clin Oncol. 2012;9(1):16–32.
   Web of Science ®Google Scholar