Treatment of advanced HER2-positive breast cancer: 2018 and beyond
Tài liệu tham khảo
Hanahan, 2011, Hallmarks of cancer: the next generation, Cell, 144, 646, 10.1016/j.cell.2011.02.013
Slamon, 1987, Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene, Science, 235, 177, 10.1126/science.3798106
Slamon, 1989, Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer, Science, 244, 707, 10.1126/science.2470152
Roth J, Bajaj P, Sullivan SD et al. Survival gains from advances in first-line systemic therapy for HER2 overexpressing metastatic breast cancer in the U.S., 1995–2015. Abstract 263P, ESMO Congress 2017, Madrid, Spain.
Giordano, 2014, 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, 32, 2078, 10.1200/JCO.2013.54.0948
Cardoso, 2017, 3rd ESO–ESMO international consensus guidelines for advanced breast cancer (ABC 3), Ann Oncol, 28, 16, 10.1093/annonc/mdx036
Baselga, 2012, Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer, N Engl J Med, 366, 109, 10.1056/NEJMoa1113216
Swain, 2015, Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer, N Engl J Med, 372, 724, 10.1056/NEJMoa1413513
Verma, 2012, Trastuzumab emtansine for HER2-positive advanced breast cancer, N Engl J Med, 367, 1783, 10.1056/NEJMoa1209124
Perez, 2017, Trastuzumab emtansine with or without pertuzumab versus trastuzumab plus taxane for human epidermal growth factor receptor 2–positive, advanced breast cancer: primary results from the phase III MARIANNE study, J Clin Oncol, 35, 141, 10.1200/JCO.2016.67.4887
Diéras, 2017, Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial, Lancet Oncol, 18, 732, 10.1016/S1470-2045(17)30312-1
Blackwell, 2010, Randomized study of lapatinib alone or in combination with trastuzumab in women with ErbB2-positive, trastuzumab-refractory metastatic breast cancer, J Clin Oncol, 28, 1124, 10.1200/JCO.2008.21.4437
Geyer, 2006, Lapatinib plus capecitabine for HER2-positive advanced breast cancer, N Engl J Med, 355, 2733, 10.1056/NEJMoa064320
Burstein, 2007, Trastuzumab plus vinorelbine or taxane chemotherapy for HER2-overexpressing metastatic breast cancer: the trastuzumab and vinorelbine or taxane study, Cancer, 110, 965, 10.1002/cncr.22885
Krop, 2014, 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, 15, 689, 10.1016/S1470-2045(14)70178-0
Krop, 2017, Trastuzumab emtansine versus treatment of physician’s choice in patients with previously treated HER2-positive metastatic breast cancer (TH3RESA): final overall survival results from a randomised open-label phase 3 trial, Lancet Oncol, 18, 743, 10.1016/S1470-2045(17)30313-3
Seferina, 2015, Real-life use and effectiveness of adjuvant trastuzumab in early breast cancer patients: a study of the southeast netherlands breast cancer consortium, Oncologist, 20, 856, 10.1634/theoncologist.2015-0006
Urruticoechea, 2017, Randomized phase III trial of trastuzumab plus capecitabine with or without pertuzumab in patients with human epidermal growth factor receptor 2–positive metastatic breast cancer who experienced disease progression during or after trastuzumab-based therapy, J Clin Oncol, 35, 3030, 10.1200/JCO.2016.70.6267
Garrone O, D’Onofrio L, Blondeaux E. Moving from the CLEOPATRA study to real life: preliminary results from the G.O.N.O. SUPER trial n.d.
Ricciardi, 2017, Efficacy and safety of the combination of pertuzumab (P) plus trastuzumab (T) plus docetaxel (D) for HER-2 positive metastatic breast cancer (MBC) in pretreated patients (pts) with trastuzumab in the neo/adjuvant setting: a real-life study, J Clin Oncol, 35, 10.1200/JCO.2017.35.15_suppl.e12516
Daniels, 2017, Use and outcomes of targeted therapies in early and metastatic HER2-positive breast cancer in Australia: protocol detailing observations in a whole of population cohort, BMJ Open, 7, e014439, 10.1136/bmjopen-2016-014439
Vici, 2017, A retrospective multicentric observational study of trastuzumab emtansine in HER2 positive metastatic breast cancer: a real-world experience, Oncotarget, 8, 56921, 10.18632/oncotarget.18176
Fabi, 2017, Ado-trastuzumab emtansine (T-DM1) in HER2+ advanced breast cancer patients: does pretreatment with pertuzumab matter?, Future Oncol Lond Engl, 13, 2791, 10.2217/fon-2017-0336
Báez-Vallecillo, 2017, Abstract P4-21-20: Lapatinib after pertuzumab and ado-trastuzumab emtansine in metastatic HER2-positive breast cancer, Cancer Res, 77, P4, 10.1158/1538-7445.SABCS16-P4-21-20
Muss, 2011, Coming of age: breast cancer in seniors, Oncologist, 16, 79, 10.1634/theoncologist.2011-S1-79
Biganzoli, 2012, Management of elderly patients with breast cancer: updated recommendations of the International Society of Geriatric Oncology (SIOG) and European Society of Breast Cancer Specialists (EUSOMA), Lancet Oncol, 13, e148, 10.1016/S1470-2045(11)70383-7
Hurria, 2012, Research priorities in geriatric oncology: addressing the needs of an aging population, J Natl Compr Cancer Netw JNCCN, 10, 286, 10.6004/jnccn.2012.0025
Hurria, 2014, Designing therapeutic clinical trials for older and frail adults with cancer: U13 conference recommendations, J Clin Oncol, 32, 2587, 10.1200/JCO.2013.55.0418
Miles, 2013, Treatment of older patients with HER2-positive metastatic breast cancer with pertuzumab, trastuzumab, and docetaxel: subgroup analyses from a randomized, double-blind, placebo-controlled phase III trial (CLEOPATRA), Breast Cancer Res Treat, 142, 89, 10.1007/s10549-013-2710-z
Cetin, 2013, Lapatinib plus capecitabine for HER2-positive advanced-stage breast cancer in elderly women: review of the Anatolian Society of Medical Oncology (ASMO) experience, Breast Care, 8, 67, 10.1159/000346829
Kaufman, 2012, Treatment patterns and clinical outcomes in elderly patients with HER2-positive metastatic breast cancer from the registHER observational study, Breast Cancer Res Treat, 135, 875, 10.1007/s10549-012-2209-z
Barrios, 2015, Safety of trastuzumab emtansine (T-DM1) in 373 patients 65 years or older with HER2-positive advanced breast cancer: a subgroup analysis of the Kamilla study., Abstract 603 ASCO 2015 Journal of Clinical Oncology, 33
Wildiers, 2018, Pertuzumab and trastuzumab with or without metronomic chemotherapy for older patients with HER2-positive metastatic breast cancer (EORTC 75111–10114): an open-label, randomised, phase 2 trial from the Elderly Task Force/Breast Cancer Group, Lancet Oncol, 19, 323, 10.1016/S1470-2045(18)30083-4
Cherny, 2017, ESMO-magnitude of clinical benefit scale version 1.1, Ann Oncol Off J Eur Soc Med Oncol, 28, 2340, 10.1093/annonc/mdx310
Durkee, 2016, Cost-effectiveness of pertuzumab in human epidermal growth factor receptor 2–positive metastatic breast cancer, J Clin Oncol, 34, 902, 10.1200/JCO.2015.62.9105
Fleeman, 2015, Pertuzumab in combination with trastuzumab and docetaxel for the treatment of HER2-positive metastatic or locally recurrent unresectable breast cancer, PharmacoEconomics, 33, 13, 10.1007/s40273-014-0206-2
Le, 2016, Cost-effectiveness analysis of trastuzumab emtansine (T-DM1) in human epidermal growth factor receptor 2 (HER2): positive advanced breast cancer, Breast Cancer Res Treat, 159, 565, 10.1007/s10549-016-3958-x
Squires, 2016, Trastuzumab emtansine for treating HER2-positive, unresectable, locally advanced or metastatic breast cancer after treatment with trastuzumab and a taxane: an evidence review group perspective of a NICE single technology appraisal, PharmacoEconomics, 34, 673, 10.1007/s40273-016-0386-z
Diaby, 2016, Cost-effectiveness analysis of 1st through 3rd line sequential targeted therapy in HER2-positive metastatic breast cancer in the United States, Breast Cancer Res Treat, 160, 187, 10.1007/s10549-016-3978-6
Prat, 2017, Intrinsic molecular subtypes of HER2+ breast cancer, Oncotarget, 10.18632/oncotarget.20629
Tolaney, SM, Barry W, Guo H et al. Immune profile of small HER2+ tumors in the APT trial. Abstract PD03-01, SABCS 2017, San Antonio, Texas, US.
Llombart-Cussac, 2017, HER2-enriched subtype as a predictor of pathological complete response following trastuzumab and lapatinib without chemotherapy in early-stage HER2-positive breast cancer (PAMELA): an open-label, single-group, multicentre, phase 2 trial, Lancet Oncol, 10.1016/S1470-2045(17)30021-9
Kaufman, 2009, 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, 27, 5529, 10.1200/JCO.2008.20.6847
Huober, 2012, 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, The Breast, 21, 27, 10.1016/j.breast.2011.07.006
Johnston, 2009, Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer, J Clin Oncol Off J Am Soc Clin Oncol, 27, 5538, 10.1200/JCO.2009.23.3734
Arpino, 2017, Cancer Res, 77, S3, 10.1158/1538-7445.SABCS16-S3-04
Johnston SRD, Hegg R, Im S-A, Park IH, Burdaeva O, Kurteva G, 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: ALTERNATIVE. J Clin Oncol Off J Am Soc Clin Oncol 2017:JCO2017747824. doi: 10.1200/JCO.2017.74.7824.
Piccart, 2013, Why your preferred targeted drugs may become unaffordable, Cancer Res, 73, 5849, 10.1158/0008-5472.CAN-13-1486
Wolff, 2013, 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 Off J Am Soc Clin Oncol, 31, 3997, 10.1200/JCO.2013.50.9984
Gingras, 2017, HER2-positive breast cancer is lost in translation: time for patient-centered research, Nat Rev Clin Oncol, 14, 669, 10.1038/nrclinonc.2017.96
Taube, 2009, A perspective on challenges and issues in biomarker development and drug and biomarker codevelopment, JNCI J Natl Cancer Inst, 101, 1453, 10.1093/jnci/djp334
Baselga, 2016, Relationship between tumor biomarkers and efficacy in EMILIA, a phase III study of trastuzumab emtansine in HER2-positive metastatic breast cancer, Clin Cancer Res Off J Am Assoc Cancer Res, 10.1158/1078-0432.CCR-15-2499
Baselga, 2014, 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 Off J Am Soc Clin Oncol, 32, 3753, 10.1200/JCO.2013.54.5384
Kim, 2016, Relationship between tumor biomarkers and efficacy in TH3RESA, a phase III study of trastuzumab emtansine (T-DM1) vs. treatment of physician’s choice in previously treated HER2-positive advanced breast cancer: Biomarker analyses in TH3RESA, Int J Cancer, 139, 2336, 10.1002/ijc.30276
Schlange, 2016, Potential of circulating tumor cells as blood-based biomarkers in cancer liquid biopsy, Pharmacogenomics, 17, 183, 10.2217/pgs.15.163
Ma, 2017, Neratinib efficacy and circulating tumor DNA detection of HER2 mutations in HER2 nonamplified metastatic breast cancer, Clin Cancer Res, 23, 5687, 10.1158/1078-0432.CCR-17-0900
Ma, 2017, Phase I study and biomarker analysis of pyrotinib, a novel irreversible Pan-ErbB receptor tyrosine kinase inhibitor, in patients with human epidermal growth factor receptor 2–positive metastatic breast cancer, J Clin Oncol, 35, 3105, 10.1200/JCO.2016.69.6179
Deri, 2013, PET imaging with 89Zr: from radiochemistry to the clinic, Nucl Med Biol, 40, 3, 10.1016/j.nucmedbio.2012.08.004
Sandstrom, 2016, Biodistribution and radiation dosimetry of the anti-HER2 affibody molecule 68Ga-ABY-025 in breast cancer patients, J Nucl Med, 57, 867, 10.2967/jnumed.115.169342
Sörensen, 2016, Measuring HER2-receptor expression in metastatic breast cancer using [68Ga]ABY-025 affibody PET/CT, Theranostics, 6, 262, 10.7150/thno.13502
Kurihara H, Hamada A, Yoshida M, Shimma S, Hashimoto J, Yonemori K, et al. 64Cu-DOTA-trastuzumab PET imaging and HER2 specificity of brain metastases in HER2-positive breast cancer patients. EJNMMI Res 2015;5. doi: 10.1186/s13550-015-0082-6.
Gebhart, 2016, Molecular imaging as a tool to investigate heterogeneity of advanced HER2-positive breast cancer and to predict patient outcome under trastuzumab emtansine (T-DM1): the ZEPHIR trial, Ann Oncol Off J Eur Soc Med Oncol ESMO, 27, 619, 10.1093/annonc/mdv577
Curtis, 2012, The genomic and transcriptomic architecture of 2000 breast tumours reveals novel subgroups, Nature, 486, 346, 10.1038/nature10983
Hendrickx, 2017, Identification of genetic determinants of breast cancer immune phenotypes by integrative genome-scale analysis, OncoImmunology, 6, e1253654, 10.1080/2162402X.2016.1253654
Kim, 2017, Programmed death-ligand 1 (PD-L1) expression in tumour cell and tumour infiltrating lymphocytes of HER2-positive breast cancer and its prognostic value, Sci Rep, 7, 11671, 10.1038/s41598-017-11905-7
Luen, 2017, Tumour-infiltrating lymphocytes in advanced HER2-positive breast cancer treated with pertuzumab or placebo in addition to trastuzumab and docetaxel: a retrospective analysis of the CLEOPATRA study, Lancet Oncol, 18, 52, 10.1016/S1470-2045(16)30631-3
Stagg, 2011, Anti–ErbB-2 mAb therapy requires type I and II interferons and synergizes with anti–PD-1 or anti-CD137 mAb therapy, Proc Natl Acad Sci, 108, 7142, 10.1073/pnas.1016569108
Loi S, Giobbe-Hurder A, Gombos A et al. Phase Ib/II study evaluating safety and efficacy of pembrolizumab and trastuzumab in patients with trastuzumab-resistant HER2-positivemetastatic breast cancer: Results from the PANACEA (IBCSG 45-13/BIG 4-13/KEYNOTE-014) study. Abstract GS2-06. SABCS 2017. San Antonio, Texas, US.
Kontermann, 2015, Bispecific antibodies, Drug Discov Today, 20, 838, 10.1016/j.drudis.2015.02.008
Geuijen C, Rovers E, Gallenne T, Maussang-Detaille D, Kramer A, Nieuwenhuizen N, et al. Abstract LB-261: Mechanism of action of MCLA-128, a humanized bispecific IgG1 antibody targeting the HER2:HER3 heterodimer. Cancer Res 2015;75:LB-261. doi: 10.1158/1538-7445.AM2015-LB-261.
Alsina, 2017, First-in-human phase 1/2 study of MCLA-128, a full length IgG1 bispecific antibody targeting HER2 and HER3: Final phase 1 data and preliminary activity in HER2+ metastatic breast cancer (MBC), J Clin Oncol, 35, 10.1200/JCO.2017.35.15_suppl.2522
Meric-Bernstam, 2017, Phase 1 dose escalation of ZW25, a HER2-targeted bispecific antibody, in patients (pts) with HER2-expressing cancers, J Clin Oncol, 35, 10.1200/JCO.2017.35.15_suppl.1035
Croset A, Macoin J, Ollier R, Pluess M, Delon C, Skegro D, et al. 139 GBR1302: a BEAT® bispecific antibody for the treatment of HER2 positive cancers. Eur J Cancer n.d.; 50:48. doi: 10.1016/S0959-8049(14)70265-5.
Beck, 2017, Strategies and challenges for the next generation of antibody–drug conjugates, Nat Rev Drug Discov, 16, 315, 10.1038/nrd.2016.268
Aftimos PG, van Herpen CM, Mommers EC et al. SYD985, a novel anti-HER2 ADC, shows promising activity in patients with HER2-positive and HER2-low metastatic breast cancer. Abstract P6-12-02. SABCS 2016, San Antonio, Texas, US.
Doi, 2017, Single agent activity of DS-8201a, a HER2-targeting antibody-drug conjugate, in heavily pretreated HER2 expressing solid tumors, J Clin Oncol, 35, 10.1200/JCO.2017.35.15_suppl.108
Modi S, Tsurutani J, Takahashi S. Safety and efficacy results from a phase 1 study of DS-8201a in patients with HER2 expressing breast cancers. Abstract PD3-07, SABCS 2017, San Antonio, Texas, US.
Arteaga, 2006, Can trastuzumab be effective against tumors with low HER2/Neu (ErbB2) receptors?, J Clin Oncol, 24, 3722, 10.1200/JCO.2006.06.5268
Miller K, Cortes J, Hurvitz SA, Krop IE, Tripathy D, Verma S, et al. HERMIONE: a randomized Phase 2 trial of MM-302 plus trastuzumab versus chemotherapy of physician’s choice plus trastuzumab in patients with previously treated, anthracycline-naïve, HER2-positive, locally advanced/metastatic breast cancer. BMC Cancer 2016;16. doi: 10.1186/s12885-016-2385-z.
LoRusso P, Krop I, Miller K, Ma C, Siegel BA, Shields AF, et al. Abstract CT234: a phase I study of MM-302, a HER2-targeted PEGylated liposomal doxorubicin, in patients with HER2+ metastatic breast cancer. Cancer Res 2015;75:CT234-CT234. doi: 10.1158/1538-7445.AM2015-CT234.
Li, 2016, Abstract 2970: MEDI4276, a HER2-targeting antibody tubulysin conjugate, displays potent in vitro and in vivo activity in preclinical studies, Cancer Res, 76
Bergstrom DA, Bodyak N, Park PU. XMT-1522 induces tumor regressions in pre-clinical models representing HER2-positive and HER2 low-expressing breast cancer. Abstract P4-14-28. SABCS 2015, San Antonio, Texas, US.
Collins, 2012, Trastuzumab induces antibody-dependent cell-mediated cytotoxicity (ADCC) in HER-2-non-amplified breast cancer cell lines, Ann Oncol, 23, 1788, 10.1093/annonc/mdr484
Gavin, 2017, Association of polymorphisms in FCGR2A and FCGR3A with degree of trastuzumab benefit in the adjuvant treatment of ERBB2/HER2–positive breast cancer: analysis of the NSABP B-31 trial, JAMA Oncol, 3, 335, 10.1001/jamaoncol.2016.4884
Nordstrom, 2011, Anti-tumor activity and toxicokinetics analysis of MGAH22, an anti-HER2 monoclonal antibody with enhanced Fcγ receptor binding properties, Breast Cancer Res BCR, 13, R123, 10.1186/bcr3069
Bang YJ, Giaccone G, Im SA, Oh DY, Bauer TM, Nordstrom JL, et al. First-in-human Phase 1 study of margetuximab (MGAH22), an Fc-modified chimeric monoclonal antibody, in patients with HER2-positive advanced solid tumors. Ann Oncol 2017:mdx002. doi: 10.1093/annonc/mdx002.
Wang X, Batty KM, Crowe PJ, Goldstein D, Yang J-L. The Potential of panHER Inhibition in Cancer. Front Oncol 2015;5. doi: 10.3389/fonc.2015.00002.
Pivot, 2015, CEREBEL (EGF111438): a Phase III, randomized, open-label study of lapatinib plus capecitabine versus trastuzumab plus capecitabine in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer, J Clin Oncol Off J Am Soc Clin Oncol, 33, 1564, 10.1200/JCO.2014.57.1794
de Azambuja, 2013, Phase I trial combining temozolomide plus lapatinib for the treatment of brain metastases in patients with HER2-positive metastatic breast cancer: the LAPTEM trial, Ann Oncol Off J Eur Soc Med Oncol ESMO, 24, 2985, 10.1093/annonc/mdt359
Harbeck, 2016, Afatinib plus vinorelbine versus trastuzumab plus vinorelbine in patients with HER2-overexpressing metastatic breast cancer who had progressed on one previous trastuzumab treatment (LUX-Breast 1): an open-label, randomised, phase 3 trial, Lancet Oncol, 17, 357, 10.1016/S1470-2045(15)00540-9
Cortés, 2015, Lancet Oncol, 16, 1700, 10.1016/S1470-2045(15)00373-3
Awada, 2016, Neratinib plus paclitaxel vs trastuzumab plus paclitaxel in previously untreated metastatic ERBB2-positive breast cancer: the NEfERT-T randomized clinical trial, JAMA Oncol, 2, 1557, 10.1001/jamaoncol.2016.0237
Barcenas CH. Incidence and severity of diarrhea with neratinib + intensive loperamide prophylaxis in patients (pts) with HER2+ early-stage breast cancer (EBC): Interim analysis from the multicenter, open-label, phase II control trial n.d.
Park YH, Lee K, Sohn J et al. A Phase 2 study of poziotinib in patients with HER2-positive Metastatic Breast Cancer (MBC) who have received prior HER2 regimens for MBC. Abstract 237O. ESMO 2017, Madrid, Spain.
Moulder, 2017, Phase I study of ONT-380, a HER2 inhibitor, in patients with HER2+ – advanced solid tumors, with an expansion cohort in HER2+ Metastatic Breast Cancer (MBC), Clin Cancer Res, 23, 3529, 10.1158/1078-0432.CCR-16-1496
Anders C, Murthy R, Hamilton E, Borges V, Cameron D, Carey L, et al. Abstract CT055: A randomized, double-blinded, controlled study of tucatinib (ONT-380) vs. placebo in combination with capecitabine (C) and trastuzumab (Tz) in patients with pretreated HER2+ unresectable locally advanced or metastatic breast carcinoma (MBC) (HER2CLIMB). Cancer Res 2017;77:CT055-CT055. doi: 10.1158/1538-7445.AM2017-CT055.
LoRusso, 2016, Inhibition of the PI3K/AKT/mTOR Pathway in Solid Tumors, J Clin Oncol, 34, 3803, 10.1200/JCO.2014.59.0018
André, 2014, Everolimus for women with trastuzumab-resistant, HER2-positive, advanced breast cancer (BOLERO-3): a randomised, double-blind, placebo-controlled phase 3 trial, Lancet Oncol, 15, 580, 10.1016/S1470-2045(14)70138-X
Dey, 2017, PI3K-AKT-mTOR inhibitors in breast cancers: from tumor cell signaling to clinical trials, Pharmacol Ther, 175, 91, 10.1016/j.pharmthera.2017.02.037
Baselga, 2017, Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial, Lancet Oncol, 18, 904, 10.1016/S1470-2045(17)30376-5
Di Leo A, Johnston S, Lee KS, Ciruelos E, Lønning PE, Janni W, et al. Buparlisib plus fulvestrant in postmenopausal women with hormone-receptor-positive, HER2-negative, advanced breast cancer progressing on or after mTOR inhibition (BELLE-3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol n.d. doi: 10.1016/S1470-2045(17)30688-5.
Loibl, 2017, Neoadjuvant buparlisib plus trastuzumab and paclitaxel for women with HER2+ primary breast cancer: a randomised, double-blind, placebo-controlled phase II trial (NeoPHOEBE), Eur J Cancer, 85, 133, 10.1016/j.ejca.2017.08.020
Shah, 2015, Phase I study of LJM716, BYL719, and trastuzumab in patients (pts) with HER2-amplified (HER2+) metastatic breast cancer (MBC), J Clin Oncol, 33, 10.1200/jco.2015.33.15_suppl.590
Jain, 2017, Phase I study of alpelisib (BYL-719) and T-DM1 in HER2-positive metastatic breast cancer after trastuzumab and taxane therapy, J Clin Oncol, 35, 10.1200/JCO.2017.35.15_suppl.1026
Hudis, 2013, A phase 1 study evaluating the combination of an allosteric AKT inhibitor (MK-2206) and trastuzumab in patients with HER2-positive solid tumors, Breast Cancer Res, 15, R110, 10.1186/bcr3577
Wisinski, 2016, Phase 1 study of an AKT-inhibitor (MK-2206) combined with lapatinib in adult solid tumors followed by dose-expansion in advanced HER2+ breast cancer, Clin Cancer Res Off J Am Assoc Cancer Res, 22, 2659, 10.1158/1078-0432.CCR-15-2365
Goel, 2016, Overcoming therapeutic resistance in HER2-positive breast cancers with CDK4/6 inhibitors, Cancer Cell, 29, 255, 10.1016/j.ccell.2016.02.006
Corona, 2017, CDK4/6 inhibitors in HER2-positive breast cancer, Crit Rev Oncol Hematol, 112, 208, 10.1016/j.critrevonc.2017.02.022
Trapani, 2017, Entinostat for the treatment of breast cancer, Expert Opin Investig Drugs, 26, 965, 10.1080/13543784.2017.1353077
Lim B. Open-label phase Ib study of entinostat (E), and lapatinib (L) alone, and in combination with trastuzumab (T) in patients (pts) with HER2+ metastatic (mHER2+) breast cancer after progression on trastuzumab. n.d.
Plückthun, 2015, designed ankyrin repeat proteins (DARPins): binding proteins for research, diagnostics, and therapy, Annu Rev Pharmacol Toxicol, 55, 489, 10.1146/annurev-pharmtox-010611-134654
Baird R. MP0274-CP101: a phase 1, first-in-human, single-arm, multi-center, open-label, dose escalation study to assess safety, tolerability, and pharmacokinetics of MP0274 in patients with advanced HER2-positive solid tumors n.d.