Efficacy of HER2-targeted therapy in metastatic breast cancer. Monoclonal antibodies and tyrosine kinase inhibitors

Breast

Volumn 22, Issue 1, 2013, Pages 1-12

  Nielsen, Dorte L ^a   Kümler, Iben ^a   Palshof, Jesper A E ^a   Andersson, Michael ^a  

^a UNIVERSITY OF COPENHAGEN   (Denmark)

Author keywords

Breast cancer; Human epidermal growth factor receptor; Lapatinib; Targeted therapy; Trastuzumab

Indexed keywords

AFATINIB; ANASTROZOLE; ANTINEOPLASTIC AGENT; ARRY 380; CAPECITABINE; CYCLOPHOSPHAMIDE; DOCETAXEL; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ERLOTINIB; ERTUMAXOMAB; ESTROGEN RECEPTOR; FULVESTRANT; GEFITINIB; LAPATINIB; LETROZOLE; MITOGEN ACTIVATED PROTEIN KINASE; NAVELBINE; NERATINIB; PACLITAXEL; PERTUZUMAB; PHOSPHATIDYLINOSITOL 3 KINASE; PLACEBO; TRASTUZUMAB; TRASTUZUMAB EMTANSINE; UNCLASSIFIED DRUG;

BRAIN METASTASIS; BREAST CANCER; BREAST METASTASIS; CANCER COMBINATION CHEMOTHERAPY; CANCER RESISTANCE; CANCER SURVIVAL; CARDIOMYOPATHY; CARDIOTOXICITY; DIARRHEA; DRUG DOSE SEQUENCE; DRUG EFFICACY; DRUG POTENTIATION; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; ENZYME ACTIVATION; HEART DISEASE; HUMAN; MOLECULARLY TARGETED THERAPY; MONOTHERAPY; OVERALL SURVIVAL; PRIORITY JOURNAL; REVIEW; SIGNAL TRANSDUCTION; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT;

EID: 84871713793     PISSN: 09609776     EISSN: 15323080     Source Type: Journal    
DOI: 10.1016/j.breast.2012.09.008     Document Type: Review

References (100)

1. Cardoso F., Bedard P.L., Winer E.P., Pagani O., Senkus-Konefka E., Fallowfield L.J., et al. International guidelines for management of metastatic breast cancer: combination vs sequential single-agent chemotherapy. J Natl Cancer Inst 2009, 101:1174-1181.
2. Nahta R., Esteva F.J. Herceptin: mechanisms of action and resistance. Cancer Lett 2006, 232:123-138.
3. Witton C.J., Reeves J.R., Going J.J., Cooke T.G., Bartlett J.M. Expression of the HER1-4 family of receptor tyrosine kinases in breast cancer. J Pathol 2003, 200:290-297.
4. Rosen L.S., Ashurst H.L., Chap L. Targeting signal transduction pathways in metastatic breast cancer: a comprehensive review. Oncologist 2010, 15:216-235.
5. Wolff A.C., Hammond M.E., Schwartz J.N., Hagerty K.L., Allred D.C., Cote R.J., et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth receptor 2 testing in breast cancer. J Clin Oncol 2007, 25:118-145.
6. Seidman A.D., Berry D., Cirrincione C., Harris L., Muss H., Marcom P.K., et al. Randomized phase III trial of weekly compared with every-3-weeks paclitaxel for metastatic breast cancer, with trastuzumab for all HER-2 non overexpressors: final results of Cancer and Leukaemia Group B Protocol 9840. J Clin Oncol 2008, 26:1642-1649.
7. Slamon D.J., Leyland-Jones B., Shak S., Fuchs H., Paton V., Bajamonde A., et al. Use of chemotherapy plus monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001, 344:783-792.
8. Marty M., Cognetti F., Maraninchi D., Snyder R., Mauriac L., Tubiana-Hulin M., et al. Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group. J Clin Oncol 2005, 23:4265-4274.
9. Gasparini G., Gion M., Mariani L., Papaldo P., Crivellari D., Filippelli G., et al. Randomized phase II trial of weekly paclitaxel alone versus trastuzumab plus weekly paclitaxel as first-line therapy of patients with Her-2 positive advanced breast cancer. Breast Cancer Res Treat 2007, 101:355-365.
10. Nielsen D.L., Andersson, Kamby C. HER2-targeted therapy in breast cancer. Monoclonal antibodies and tyrosine kinase inhibitors. Cancer Treat Rev 2009, 35:121-136.
11. Robert N., Leyland-Jones B., Asmar L., Belt R., Ilegbodu D., Loesch D., et al. Randomized phase III study of trastuzumab, paclitaxel, and carboplatin compared with trastuzumab and paclitaxel in women with HER-2 overexpressing metastatic breast cancer: an update including survival. J Clin Oncol 2006, 24:2786-2792.
12. Burstein H.J., Keshaviah A., Baron A.D., Hart R.D., Lambert-Falls R., Marcom P.K., et al. Trastuzumab plus vinorelbine or taxane chemotherapy for HER2-overexpressing metastatic breast cancer: the trastuzumab and vinorelbine or taxane study. Cancer 2007, 110:965-972.
13. Valero V., Forbes J., Pegram M.D., Pienkowski T., Eiermann W., von Minckwitz G., et al. Multicenter phase III randomized trial comparing docetaxel and trastuzumab with docetaxel, carboplatin, and trastuzumab as first-line chemotherapy for patients with HER2-gene-amplified metastatic breast cancer (BCIRG 007 Study): two highly active therapeutic regimens. J Clin Oncol 2011, 29:149-156.
14. Wardley A.M., Pivot X., Morales-Vasquez F., Zetina L.M., de Fátima Dias Gaui M., Reyes D.O., et al. Randomized phase II trial of first-line trastuzumab plus docetaxel and capecitabine compared with trastuzumab plus docetaxel in HER2-positive metastatic breast cancer. J Clin Oncol 2010, 28:976-983.
15. Andersson M., Lidbrink E., Bjerre K., Wist E., Enevoldsen K., Jensen A.B., et al. Phase III randomized study comparing docetaxel plus trastuzumab with vinorelbine plus trastuzumab as first-line therapy of metastatic or locally advanced human epidermal growth factor receptor 2-positive breast cancer: the HERNATA study. J Clin Oncol 2011, 29:264-271.
16. Shou J., Massarweh S., Osborne C.K., Wakeling A.E., Ali S., Weiss H., et al. Mechanisms of tamoxifen resistance: increased estrogen receptor-HER2/neu cross-talk in ER/HER2-positive breast cancer. Natl Cancer Inst 2004, 96:926-935.
17. Koeberle D., Ruhstaller T., Jost L., Pagani O., Zaman K., von Moos R., et al. Combination of trastuzumab and letrozole after resistance to sequential trastuzumab and aromatase inhibitor monotherapies in patients with estrogen receptor-positive, HER-2-positive advanced breast cancer: a proof-of-concept trial (SAKK 23/03). Endocr Relat Cancer 2011, 18:257-264.
18. Kaufman B., Mackey J.R., Clemens M.R., Bapsy P.P., Vaid A., Wardley A., 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.
19. Huober J., Fasching P.A., Barsoum M., Petruzelka L., Wallwiener D., Thomssen C., et al. Higher efficacy of letrozole in combination with trastuzumab compared to letrozole monotherapy as first-line treatment in patients with HER2-positive, hormone-receptor-positive metastatic breast cancer - results of the eLEcTRA trial. Breast 2012, 21:27-33.
20. Prat A., Baselga J. The role of hormonal therapy in the management of hormonal-receptor-positive breast cancer with co-expression of HER2. Nat Clin Prac Oncol 2008, 5:531-542.
21. Hamberg P., Bos M.M., Braun H.J., Stouthard J.M., van Deijk G.A., Erdkamp F.L., et al. Randomized phase II study comparing efficacy and safety of combination-therapy trastuzumab and docetaxel vs. sequential therapy of trastuzumab followed by docetaxel alone at progression as first-line chemotherapy in patients with HER2+ metastatic breast cancer: HERTAX trial. Clin Breast Cancer 2011, 11:103-113.
22. Inoue K., Nakagami K., Mizutani M., Hozumi Y., Fujiwara Y., Masuda N., et al. Randomized phase III trial of trastuzumab monotherapy followed by trastuzumab plus docetaxel versus trastuzumab plus docetaxel as first-line therapy in patients with HER2-positive metastatic breast cancer: the JO17360 Trial Group. Breast Cancer Res Treat 2010, 119:127-136.
23. Tripathy D., Slamon D.J., Cobleigh M., Arnold A., Saleh M., Mortimer J.E., et al. Safety of treatment of metastatic breast cancer with trastuzumab beyond disease progression. J Clin Oncol 2004, 22:1063-1070.
24. von Minckwitz G., du Bois A., Schmidt M., Maass N., Cufer T., de Jongh F.E., et al. Trastuzumab beyond progression in human epidermal growth factor receptor 2-positive advanced breast cancer: a German Breast Group 26/Breast International Group 03-05 Study. J Clin Oncol 2009, 27:1999-2006.
25. Mannocci A., De Feo E., de Waure C., Specchia M.L., Gualano M.R., Barone C., et al. Use of trastuzumab in HER2-positive metastatic breast cancer beyond disease progression: a systematic review of published studies. Tumors 2010 May-Jun, 96(3):385-391.
26. Baselga J., Smith B.L., Rafferty E.A., Bombonati A. Case 16-2012-A 32-year-old woman with HER2-positive breast cancer. N Engl J Med 2012, 366:2018-2026.
27. Guarneri V., Lenihan D.J., Valero V., Durand J.B., Broglio K., Hess K.R., et al. Long term cardiac tolerability of trastuzumab in metastatic breast cancer: the M.D. Anderson Center experience. J Clin Oncol 2006, 24:4107-4115.
28. Montagna E., Cancello G., D'Agostino D., Lauria R., Forestieri V., Esposito A., et al. Central nervous system metastases in a cohort of metastatic breast cancer patients treated with trastuzumab. Cancer Chemother Pharmacol 2009, 63:275-280.
29. Stemmler H.J., Schmitt M., Willems A., Bernhard H., Harbeck N., Heinemann V. Ratio of trastuzumab levels in serum and cerebrospinal fluid is altered in HER2-positive breast cancer patients with brain metastases and impairment of blood-brain barrier. Anticancer Drugs 2007, 18:23-82.
30. Leyland-Jones B. Human epidermal growth factor receptor 2-positive breast cancer and central nervous system metastases. J Clin Oncol 2009, 27:5278-5286.
31. Park Y.H., Park M.J., Ji S.H., Yi S.Y., Lim D.H., Nam D.H., et al. Trastuzumab treatment improves brain metastasis outcomes through control and durable prolongation of systemic extracranial disease in HER2-overexpressing breast cancer. Br J Cancer 2009, 100:894-900.
32. Brufsky A.M., Mayer M., Rugo H.S., Kaufman P.A., Tan-Chiu E., Tripathy D., et al. Central nervous system metastases in patients with HER2-positive metastatic breast cancer: incidence, treatment, and survival in patients from registHER. Clin Cancer Res 2011, 17:4834-4843.
33. Bernard-Marty C., Lebrun F., Awarda A., Piccart M.J. Monoclonal antibody-based targeted therapy in breast cancer: current status and future directions. Drugs 2006, 66:1577-1591.
34. Cortés J., Fumoleau P., Bianchi G.V., Petrella T.M., Gelmon K., Pivot X., et al. Pertuzumab monotherapy after trastuzumab-based treatment and subsequent reintroduction of trastuzumab: activity and tolerability in patients with advanced human epidermal growth factor receptor 2-positive breast cancer. Clin Oncol 2012 March 5, [Epub ahead of print].
35. Gianni L., Lladó A., Bianchi G., Cortes J., Kellokumpu-Lehtinen P.L., Cameron D.A., et al. Open-label, phase II, multicenter, randomized study of the efficacy and safety of two dose levels of pertuzumab, a human epidermal growth factor receptor 2 dimerization inhibitor, in patients with human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol 2010, 28:1131-1137.
36. Lenihan D., Suter T., Brammer M., Neate C., Ross G., Baselga J. Pooled analysis of cardiac safety in patients with cancer treated with pertuzumab. Ann Oncol 2012, 23:791-800.
37. Kiewe P., Thiel E. Ertumaxomab: a trifunctional antibody for breast cancer treatment. Expert Opin Investig Drugs 2008, 17:1553-1558.
38. Kiewe P., Hasmüller S., Kahlert S., Heinrigs M., Rack B., Marmé A., et al. Phase I trial of the trifunctional anti-HER2 x anti-CD3 antibody ertumaxomab in metastatic breast cancer. Clin Cancer Res 2006, 12:3085-3091.
39. Jäger M., Schoberth A., Ruf P., Hess J., Lindhofer H. The trifunctional antibody ertuxomab destroys tumor cells that express low levels of human epidermal growth factor receptor 2. Cancer Res 2008, 69:4270-4276.
40. Krop I.E., Beeram M., Modi S., Jones S.F., Holden S.N., Yu W., et al. Phase I study of trastuzumab-DM1, an HER2 antibody-drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer. J Clin Oncol 2010, 28:2698-2704.
41. Burris H.A., Rugo H.S., Vukelja S.J., Vogel C.L., Borson R.A., Limentani S., et al. Phase II study of the antibody drug conjugate trastuzumab-DM1 for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer after prior HER2-directed therapy. J Clin Oncol 2011, 29:398-405.
42. Krop I.E., Lorusso P., Miller K.D., Modi S., Yardley D., Rodriguez G., et al. A Phase II study of trastuzumab emtansine in patients with human epidermal growth factor receptor 2 -positive metastatic breast cancer who were previously treated with trastuzumab, lapatinib, an anthracycline, a taxane, and capecitabine. J Clin Oncol 2012 May 29, [Epub ahead of print].
43. Hurvitz SA, Dirix L, Kocsis J, Gianni L, Lu MJ, Vinholes J. Trastuzumab emtansine (T-DM1) versus trastuzumab + docetaxel in previously untreated HER2-positive metastatic breast cancer (MBC): primary results of a randomized, Multicenter, open-label phase II study (TDM4450g/BO21976). Presented at ESMO 2011, Abstract 5001.
44. Blackwell K.L., Miles D., Gianni L., Krop I.E., Welslau M., Baselga J., et al. Primary results from EMILIA, a phase III study of trastuzumab emtansine (T-DM1) versus capecitabine (X) and lapatinib (L) in HER2-positive locally advanced or metastatic breast cancer (MBC) previously treated with trastuzumab (T) and a taxane. J Clin Oncol 2012, 30(Suppl.). [abstract LBA1].
45. Moulder S.L., Baetz T., D'Aloisio S., Fernetich G., Sajan B., Freeman B., et al. A phase 1 study to assess the safety, tolerability and PK of ARRY-380-an oral HER2 inhibitor. Cancer Res 2010, 70(Suppl.). [abstract P3-14-07].
46. Konecny G.E., Pegram M.D., Venkatesan N., Finn R., Yang G., Rahmeh M., et al. Activity of the dual kinase inhibitor lapatinib (GW572016) against HER-2-overexpressing and trastuzumab treated breast cancer cells. Cancer Res 2006, 66:1630-1639.
47. Gomez H.L., Doval D.C., Chavez M.A., Ang P.C., Aziz Z., Nag S., et al. Efficacy and safety of lapatinib as first-line therapy for ErbB2-amplified locally advanced or metastatic breast cancer. J Clin Oncol 2008, 26:2999-3005.
48. Toi M., Iwata H., Fujiwara Y., Ito Y., Nakamura S., Tokuda Y., et al. Lapatinib monotherapy in patients with relapsed, advanced, or metastatic breast cancer: efficacy, safety, and biomarker results from Japanese patients phase II studies. Br J Cancer 2009, 101:1676-1682.
49. Burstein H.J., Storniolo A.M., Franco S., Forster J., Stein S., Rubin S., et al. A phase II study of lapatinib monotherapy in chemotherapy-refractory HER2-positive and HER2-negative advanced or metastatic breast cancer. Ann Oncol 2008, 19:1068-1074.
50. Blackwell K.L., Pegram M.D., Tan-Chiu E., Schwartzberg L.S., Arbushites M.C., Maltzman J.D., et al. Single-agent lapatinib for HER2-overexpressing advanced or metastatic breast cancer that progressed on first- or second-line trastuzumab-containing regimens. Ann Oncol 2009, 20:1026-1031.
51. Geyer C.E., Forster J., Lindquist D., Chan S., Romieu C.G., Pienkowski T., et al. Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006, 355:2733-2743.
52. Cameron D., Casey M., Oliva C., Newstat B., Imwalle B., Geyer C.E. Lapatinib plus capecitabine in women with HER-2-positive advanced breast cancer: final survival analysis of a phase III randomized trial. Oncologist 2010, 15:924-934.
53. Guan Z.-Z., Xu B.-H., Arpornwirat W., Tong Z.-S., Lorvidhaya V., Wang L., et al. Overall survival benefit observed with lapatinib (L) plus paclitaxel (P) as first-line therapy in patients with HER2-overexpressing metastatic breast cancer (MBC). Cancer Res 2010, 70(Suppl.). [abstract P3-14-24].
54. Di Leo A., Gomez H.L., Aziz Z., Zvirbule Z., Bines J., Arbushites M.C., et al. Phase III, double-blind, randomized study comparing lapatinib plus paclitaxel with placebo plus paclitaxel as first-line treatment for metastatic breast cancer. J Clin Oncol 2008, 26:5544-5552.
55. Gelmon K.A., Boyle F., Kaufman B., Huntsman D., Manikhas A., Di Leo A., et al. Open-label phase III randomized controlled trial comparing taxane-based chemotherapy (Tax) with lapatinib (L) or trastuzumab (T) as first-line therapy for women with HER2+ metastatic breast cancer: Interim analysis (IA) of NCIC CTG MA.31/GSK EGF 108919. J Clin Oncol 2012, 30(Suppl.). [abstact LBA671].
56. Cameron D.A., Stein S. Drug insight: intracellular inhibitors of HER2 - clinical development of lapatinib in breast cancer. Nat Clin Prac Oncol 2008, 5:512-519.
57. Sonne-Hansen K., Norrie I.C., Emdal K.B., Benjaminsen R.V., Frogne T., Christiansen I.J., et al. Breast cancer cells can switch between estrogen receptor alpha and ErbB signaling and combined treatment against both signaling pathways postpones development of resistance. Breast Cancer Res Treat 2010, 121:601-613.
58. Johnston S., Pippen J., Pivot X., Lichinitser M., Sadeghi S., Dieras V., et al. Lapatinib combined with letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol 2009, 27:5538-5546.
59. Burstein H.J., Barry W.T., Cirrincione C., Chew H.K., Tolaney S., Lake D., et al. Fulvestrant with or without lapatinib as therapy for hormone receptor positive advanced breast cancer: a double-blinded, placebo-controlled, randomized phase III study. Cancer Res 2010, 70(Suppl.). [abstract PD05-01].
60. Burris H.A. Dual kinase inhibition in the treatment of breast cancer: initial experience with the EGFR/erbB-2 inhibitor lapatinib. Oncologist 2004, 9(Suppl. 3):10-15.
61. Lin N.U., Carey L.A., Liu M.C., Younger J., Come S.E., Ewend M., et al. Phase II trial of lapatinib for brain metastases in patients with human epidermal growth factor receptor 2-positive breast cancer. J Clin Oncol 2008, 26:1993-1999.
62. Lin N.U., Diéras V., Paul D., Lossignol D., Christodoulou C., Stemmler H.J., et al. Multicenter phase II study of lapatinib in patients with brain metastases from HER2-positive breast cancer. Clin Cancer Res 2009, 15:1452-1459.
63. Bachelot T.D., Romieu G., Campone M., Dieras V., Cropet C., Roche H.H., et al. LANDSCAPE: an FNCLCC phase II study with lapatinib (L) and capecitabine (C) in patients with brain metastases (BM) from HER2-positive (+) metastatic breast cancer (MBC) before whole-brain radiotherapy (WBR). J Clin Oncol 2011, 29(Suppl.). [abstract 509].
64. Polli J.W., Humphreys J.E., Harmon K.A., Castellino S., O'Mara M.J., Olson K.L., et al. The role of efflux and uptake transporters in N- {3-Chloro-4-[(3-fluorobenzyl)oxy]phenyl}-6-[5({[2-(methylsulfonyl)ethyl]amino}methyl)-2-furyl]-4quinazolinamine (GW572016, lapatinib) disposition and drug interaction. Drug Metab Dispos 2008, 36:695-701.
65. Taskar K.S., Rudraraju V., Mittapalli R.K., Samala R., Thorsheim H.R., Lockman J., et al. Lapatinib distribution in HER2 overexpressing experimental brain metastases of breast cancer. Pharm Res 2012, 29:770-781.
66. Rabindran S.K., Discafani C.M., Rosfjord E.C., Baxter M., Floyd M.B., Golas J., et al. Antitumor activity of HKI-272, an orally active, irreversible inhibitor of the HER-2 tyrosine kinase. Cancer Res 2004, 64:3958-3965.
67. Burstein H.J., Sun Y., Dirix L.Y., Jiang Z., Paridaens R., Tan A.R., et al. Neratinib, an irreversible ErbB receptor tyrosine kinase inhibitor, in patients with advanced ErbB2-positive breast cancer. J Clin Oncol 2010, 28:1301-1307.
68. Saura C., Garcia-Saenz J.A., Xu B., Harb W., Moroose R., Pluard T., et al. Safety and efficacy of neratinib in combination with capecitabine in patients with ErbB2-positive breast cancer. Cancer Res 2011, 71(24 Suppl.). [abstract P1-12-09].
69. Martin M., Bonneterre J., Geyer C.E., Ito Y., Ro J., Lang I., et al. A phase 2, randomized, open-label, study of neratinib (HKI-272) vs lapatinib plus capecitabine for 2nd/3rd-line treatment of HER2+ locally advanced or metastatic breast cancer. Cancer Res 2011, 71(24 Suppl.). [abstract S5-7].
70. Zhao X.Q., Xie J.D., Chen X.G., Sim H.M., Zhang X., Liang Y.J., et al. Neratinib reverses ATP-binding Cassette B1-mediated chemotherapeutic drug resistance in vitro, in vivo, and ex vivo. Mol Pharmacol 2012, 82:47-58.
71. Hegedüs C., Truta-Feles K., Antalffy G., Várady G., Német K., Ozvegy-Laczka C., et al. Interaction of the EGFR inhibitors gefitinib, vandetanib, pelitinib and neratinib with the ABCG2 multidrug transporter: Implications for the emergence and reversal of cancer drug resistance. Biochem Pharmacol 2012, 84:260-267.
72. Lin N.U., Winer E.P., Wheatley D., Carey L.A., Houston S., Mendelson D., et al. A phase II study of afatinib (BIBW 2992), an irreversible ErbB family blocker, in patients with HER2-positive metastatic breast cancer progressing after trastuzumab. Breast Cancer Res Treat 2012 Mar 15, [Epub ahead of print].
73. Schuler M.H., Uttenreuther-Fischer M.M., Piccart-Gebhart M.J., Harbeck N. BIBW 2992, a novel irreversible EGFR/HER1 and HER2 tyrosine kinase inhibitor, for the treatment of patients with HER2-negative metastatic breast cancer after failure of no more than two prior chemotherapies. J Clin Oncol 2010, 28(15s). [abstract 1065].
74. Gunzer K., de Mont-Serrat H., Uttenreuther-Fischer M.M., Misset J. Addition of BIBW 2992, an irreversible inhibitor of EGFR/HER1 and HER2, to letrozole in estrogen receptor (ER)-positive metastatic breast cancer (mBC) progressing on letrozole monotherapy. J Clin Oncol 2010, 28(15s). [abstract 1072].
75. Baselga J., Gelmon K.A., Verma S., Wardley A., Conte P., Miles D., 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, 28:1138-1144.
76. Baselga J., Cortés J., Kim S.B., Im S.A., Hegg R., Im Y.H., et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 2012, 366:109-119.
77. Diéras V., Harbeck N., Albain K., Burris H., Awada A., Crivellari D., et al. Phase Ib/II trial of T-DM1 with pertuzumab for patients with HER2-positive locally advanced or metastatic breast cancer. Cancer Res 2010, 70(Suppl.). [abstract P3-14-01].
78. Arteaga C.L., O'neill A., Moulder S.L., Pins M., Sparano J.A., Sledge G.W., et al. A phase I-II study of combined blockade of the ErbB receptor network with trastuzumab and gefitinib in patients with HER2 (ErbB2)-overexpressing metastatic breast cancer. Clin Cancer Res 2008, 14:6277-6283.
79. Britten C.D., Finn R.S., Bosserman L.D., Wong S.G., Press M.F., Malik M., et al. A phase I/II trial of trastuzumab plus erlotinib in metastatic HER2-positive breast cancer: a dual ErbB targeted approach. Clin Breast Cancer 2009, 9:16-22.
80. Scaltriti M., Verma C., Guzman M. Lapatinib, a HER2 tyrosine kinase inhibitor, induces stabilization and accumulation of HER2 and potentiates trastuzumab-dependent cell cytotoxicity. Oncogene 2009, 28:803-814.
81. Storniolo A.M., Pegram M.D., Overmoyer B., Silverman P., Peacock N.W., Jones S.F., et al. A phase I, dose escalation and pharmacokinetic study of lapatinib in combination with trastuzumab in patients with advanced ErbB2-positive breast cancer. Clin Oncol 2008, 26:3317-3323.
82. Lin N.U., Mayer I.A., Najita J.S., Hobday T.J., Falkson C.I., Dees E.C., et al. TBCRC 003: phase II trial of trastuzumab (T) and lapatinib (L) in patients (pts) with HER2+ metastatic breast cancer (MBC). J Clin Oncol 2011, 29(Suppl.). [abstract 527].
83. Blackwell K.L., Burstein H.J., Storniolo A.M., Rugo H., Sledge G., Koehler M., et al. Randomized study of lapatinib alone or in combination with trastuzumab in women with ErbB2-positive, trastuzumab-refractory metastatic breast cancer. J Clin Oncol 2010, 28:1124-1130.
84. Esteva F.J., Franco S., Hagan M.K., Brewster A., Williams W., Florance A.M., et al. Updated efficacy and safety assessment of first-line therapy with lapatinib, trastuzumab, and paclitaxel in HER2+ metastatic breast cancer. J Clin Oncol 2010, 28(15S). [abstract 1046].
85. Swaby R., Blackwell K., Jiang Z., Sun Y., Dieras V., Zaman K., et al. Neratinib in combination with trastuzumab for the treatment of advanced breast cancer: a phase I/II study. J Clin Oncol 2009, 27(15S). [abstract 1004].
86. Pohlmann P.R., Mayer I.A., Mernaugh R. Resistance to trastuzumab in breast cancer. Clin Cancer Res 2009, 15:7479-7491.
87. Scaltriti M., Chandarlapaty S., Prudkin L., Aura C., Jimenez J., Angelini P.D., et al. Clinical benefit of lapatinib-based therapy in patients with Human Epidermal Growth Factor Receptor 2-positive breast tumors coexpressing the truncated p95HER2 receptor. Clin Cancer Res 2010, 16:2688-2695.
88. Boulbes D.R., Jin Q., Arold S.T., Ladbury J.E., Yu D., Esteva F.J. Mechanisms of action and biological significance of HER2 mutations in HER2-overexpressing breast cancer. Cancer Res 2010, 70(Suppl). [abstract S2-S7].
89. Gijsen M., King P., Perera T., Parker P., Larijani B., Harris A., et al. Upregulation of ADAM proteases and HER ligands through a feedback loop mediates acquired resistance to trastuzumab in HER2-amplified breast cancer. Breast Cancer Res 2010, 12(Suppl. 1):O2.
90. Dua R., Zhang J., Nhonthachit P., Penuel E., Petropoulos C., Parry G. EGFR over-expression and activation in high HER2, ER negative breast cancer cell line induces trastuzumab resistance. Breast Cancer Res Treat 2010, 122:685-697.
91. Nahta R., Yuan L.X., Zhang B., Kobayashi R., Esteva F.J. Insulin-like growth factor-I receptor/human epidermal growth factor receptor 2 heterodimerization contributes to trastuzumab resistance of breast cancer cells. Cancer Res 2005, 65:11118-11128.
92. Karamouzis M.V., Konstaninopoulos P.A., Papavassiliou A.G. Tageting MET as a strategy to overcome crosstalk-related resistance to EGFR inhibitors. Lancet Oncol 2009, 10:709-717.
93. Berns K., Horlings H.M., Hennessy B.T., Madiredjo M., Hijmans E.M., Beelen K., et al. A functional genetic approach identifies the PI3K pathway as a major determinant of trastuzumab resistance in breast cancer. Cancer Cell 2007, 12:395-402.
94. Wang L., Zhang Q., Zhang J., Sun S., Guo H., Jia Z., et al. PI3K pathway activation results in low efficacy of both trastuzumab and lapatinib. BMC Cancer 2011, 11:248.
95. Perez E.A., Dueck A.C., Reinholz M.M., Chen B., Geiger X., Jenkins R.B., et al. Effect of PTEN protein expression on benefit to adjuvant trastuzumab in early-stage HER2+ breast cancer in NCCTG adjuvant trial N9831. J Clin Oncol 2011, 29(Suppl.). [abstract 10504].
96. Nahta R., Takahashi T., Ueno N.T., Hung M.C., Esteva F.J. P27 (kip1) down-regulation is associated with trastuzumab resistance in breast cancer cells. Cancer Res 2004, 64:3981-3986.
97. Zhang S., Huang W.C., Li P., Guo H., Poh S.B., Brady S.W., et al. Combating trastuzumab resistance by targeting SRC, a common node downstream of multiple resistance pathways. Nat Med 2011, 17:461-469.
98. Cardoso F., Costa A., Norton L., Cameron D., Cufer T., Fallowfield L., et al. 1st International consensus guidelines for advanced breast cancer (ABC 1). Breast 2012, 21:242-252.
99. Baselga J., Bradbury I., Eidtmann H., Di Cosimo S., de Azambuja E., Aura C., et al. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet 2012, 379:633-640.
100. Gianni L., Pienkowski T., Im Y.H., Roman L., Tseng L.M., Liu M.C., 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.