| DESCRIPTION | - H.S. CHO ET AL., "Structure of the extracellular region of HER2 alone and in complex with the Herceptin Fab", NATURE, (2003), vol. 421, pages 756 - 760 |
| DESCRIPTION | - KAPLAN, E.L.; MEIER, PAUL., "Nonparametric estimation from incomplete observations", J. AM. STAT. ASSOC., (1958), vol. 53, pages 457 - 481 |
| DESCRIPTION | - LIGIBEL JA; WINER EP, "Trastuzumab/chemotherapy combinations in metastatic breast cancer", SEMINARS IN ONCOLOGY, (2002), vol. 29, no. 3, pages 38 - 43 |
| DESCRIPTION | - MANTEL N; HAENSZEL W., "Statistical aspects of the analysis of data from retrospective studies of disease", J. NAT, CANCER FNST., (1959), vol. 22, pages 719 - 48 |
| DESCRIPTION | - PARKIN, DM; FERNANDEZ LM, "Use of statistics to assess the global burden of breast cancer", BREAST JOURNAL., (2006), no. 12, pages 70 - 80 |
| DESCRIPTION | - PEREZ EA ET AL., "Updated results of the combined analysis of NCCTG N9831 and NSABP B-31 adjuvant chemotherapy with/without trastuzumab in patients with HER2-positive breast cancer", JOURNAL OF CLINICAL ONCOLOGY. ASCO ANNUAL MEETING PROCEEDINGS, (2007), vol. 25, no. 18S, page 512 |
| DESCRIPTION | - RABINDRAN SK ET AL., "Antitumor activity of HKI-272, an orally active, irreversible inhibitor of the HER-2 tyrosine kinase", CANCER RESEARCH, (2004), vol. 64, no. 11, pages 3958 - 65 |
| DESCRIPTION | - "Regression Models and Life Tables (with Discussion", DR COX, Journal of the Royal Statistical Society, Series B, (1972), vol. 34, pages 187 - 220 |
| DESCRIPTION | - SLAMON D, "Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene", SCIENCE, (1987), pages 177 - 182 |
| DESCRIPTION | - SMITH ET AL., "2-year follow-up of trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer: a randomized controlled trial", LANCET, (2007), vol. 369, pages 29 - 36 |
| OPPOSITION | - Anonymous, "ALTTO Trial Findings Raise Questions on Approach to Drug Development in Early Breast Cancer", (20140602), (20240402), XP093147216 |
| OPPOSITION | - Anonymous, "ALTTO Trial Findings Raise Questions on Approach to Drug Development in Early Breast Cancer", ASCO Daily News from the ASCO Annual Meeting May 30 — June 3, 2014, (20140602), ASCO Daily News from the ASCO Annual Meeting May 30 — June 3, 2014, URL: https://web.archive.org/web/20140603204409/http://am.asco.org/altto-trial-findings-raise-questions-approach-drug-development-early-breast-cancer, (20171011), XP055414543 |
| OPPOSITION | - Anonymous, "Assessment report Nerlynx", Assessment report Nerlynx, European Medicines Agency1, (20180713), pages 1 - 169, Assessment report Nerlynx, URL: https://www.ema.europa.eu/en/documents/assessment-report/nerlynx-epar-public-assessment-report_en.pdf, (20240326), XP093145802 |
| OPPOSITION | - Anonymous, "COMMISSION IMPLEMENTING DECISION of 31.8.2018 granting marketing authorisation under Regulation (EC) No 726/2004 of the European Parliament and of the Council for "Nerlynx - neratinib", a medicinal product for human use", Union Register of medicinal products for human use, European Commission, (20180831), pages 1 - 3, Union Register of medicinal products for human use, URL: https://ec.europa.eu/health/documents/community-register/2018/20180831142014/dec_142014_en.pdf, (20240307), XP093138869 |
| OPPOSITION | - Anonymous, "Definition of adjuvant therapy - ", NCI Dictionary of Cancer Terms, NCI, (20240307), pages 1 - 1, NCI Dictionary of Cancer Terms, URL: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/adjuvant-therapy, (20240307), XP093139032 |
| OPPOSITION | - Anonymous, "Metastatic breast cancer | ", Metastatic breast cancer, Breast Cancer Network Australia, (20220814), pages 1 - 3, Metastatic breast cancer, URL: https://web.archive.org/web/20220814223916/https://www.bcna.org.au/metastatic-breast-cancer/, (20240307), XP093138886 |
| OPPOSITION | - Anonymous, "Summary of opinion (initial authorisation) Nerlynx neratinib", Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 June 2018, European Medicines Agency, (20180628), pages 1 - 1, Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 June 2018, URL: https://www.ema.europa.eu/system/files/documents/smop-initial/wc500251163_en.pdf, (20240307), XP093138880 |
| OPPOSITION | - Anonymous, "Summary of Product Characteristics for Nerlynx - neratinib ", Nerlynx : EPAR - Product Information, European Commission, (20180912), pages 1 - 35, Nerlynx : EPAR - Product Information, URL: https://ec.europa.eu/health/documents/community-register/2022/20220425155346/anx_155346_en.pdf, (20240307), XP093138874 |
| OPPOSITION | - Genentech, "HIGHLIGHTS OF PRESCRIBING INFORMATION: HERCEPTIN ® (Trastuzumab)", HIGHLIGHTS OF PRESCRIBING INFORMATION: HERCEPTIN, FDA, (20080101), pages 1 - 11, HIGHLIGHTS OF PRESCRIBING INFORMATION: HERCEPTIN, URL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/103792s5175lbl.pdf, (20240326), XP093145813 |
| OPPOSITION | - George W Sledge, "The New Millennium for Adjuvant therapy in Breast Cancer", Cancer Network, (20080501), pages 1 - 7, XP055414653 |
| OPPOSITION | - Mikael Dolsten, "Cowen Conference: Wyeth Research Presentation", Wyeth Research, (20090317), pages 1 - 24, XP055414675 |
| OPPOSITION | - Petkus Douglas, Justin Victoria, "Wyeth to Present at the SG Cowen & Co. 29th Annual Healthcare Conference", Wyeth Press release, Wyeth, (20090312), pages 1 - 2, Wyeth Press release, URL: https://web.archive.org/web/20090317073212/http://www.wyeth.com/news?nav=display&navTo=/wyeth_html/home/news/pressreleases/2009/1236891184134.html, (20240307), XP093139067 |
| OPPOSITION | - Puma Biotechnology, Inc., "Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer", ClinicalTrials.gov, NCBi, (20071219), pages 1 - 15, ClinicalTrials.gov, URL: https://clinicaltrials.gov/study/NCT00300781?tab=history&a=15, (20240326), XP093145821 |
| OPPOSITION | - Simon Gaisford, "Chapter 23 Pharmaceutical preformulation", Aulton's Pharmaceutics, Edinburgh, Elsevier, (20180101), pages 380 - 406, ISBN 978-0-7020-7003-7, XP009552583 |
| OPPOSITION | - Allan Wissner et al., "The development of HKI-272 and related compounds for the treatment of cancer", Archiv der Pharmazie, (2008), vol. 341, doi:10.1002/ARDP.200800009, XP002591683 |
| OPPOSITION | - WISSNER A, MANSOUR T S, "The development of HKI-272 and related compounds for the treatment of cancer.", Archiv der Pharmazie, Wiley verlag, Weinheim, Weinheim , (20080801), vol. 341, no. 8, doi:10.1002/ARDP.200800009, ISSN 0365-6233, pages 465 - 477, XP002591683 |
| OPPOSITION | - Burstein H, Awada A, Badwe R, Dirix L, Tan A, Jacod S, Lustgarten S, Vermette J, Zacharchuk C., "6061 HKI-272, an irreversible pan erbB receptor tyrosine kinase inhibitor: preliminary phase 2 results in patients with advanced breast cancer.", Breast Cancer Research and Treatment, Springer US, New York, New York, (20071201), vol. 106, no. SUPPLEMENT 1, doi:10.1007/s10549-007-9793-3, ISSN 0167-6806, page S268, XP002591682 |
| OPPOSITION | - Hirotaka Iwase, "Current topics and perspectives on the use of aromatase inhibitors in the treatment of breast cancer", Breast Cancer, (20081001), vol. 15, no. 4, doi:10.1007/s12282-008-0071-y, pages 278 - 290, XP055414550 |
| OPPOSITION | - Hirotaka lwase null, "Current topics and perspectives on the use of aromatase inhibitors in the treatment of breast cancer", Breast Cancer, (2008), vol. 15, doi:10.1007/s12282-008-0071-y, XP055414550 |
| OPPOSITION | - JELLIFFE R. W., ET AL., "ADAPTIVE CONTROL OF DRUG DOSAGE REGIMENS: BASIC FOUNDATIONS, RELEVANT ISSUES, AND CLINICAL EXAMPLES.", INTERNATIONAL JOURNAL OF BIO-MEDICAL COMPUTING., ELSEVIER SCIENCE PUBLISHERS, SHANNON., IE, IE , (19940601), vol. 36., no. 01/02., doi:10.1016/0020-7101(94)90091-4, ISSN 0020-7101, pages 01 - 23., XP000448749 |
| OPPOSITION | - Jelliffe, R.W. ; Maire, P. ; Sattler, F. ; Gomis, P. ; Tahani, B., "Adaptive control of drug dosage regimens: Basic foundations, relevant issues, and clinical examples", INTERNATIONAL JOURNAL OF BIO-MEDICAL COMPUTING., ELSEVIER SCIENCE PUBLISHERS, SHANNON., IE, IE , (19940601), vol. 36, no. 1-2, doi:10.1016/0020-7101(94)90091-4, ISSN 0020-7101, pages 1 - 23, XP026260200 |
| OPPOSITION | - Athanassios Iliadis et al., "Apis: a software for model identification, simulation and dosage regimen calculations in clinical and experimental pharmacokinetics", Computer Methods and, (1992), vol. 38, doi:10.1016/0169-2607(92)90103-E, XP024237123 |
| OPPOSITION | - Iliadis, A. ; Brown, A.C. ; Huggins, M.L., "APIS: a software for model identification, simulation and dosage regimen calculations in clinical and experimental pharmacokinetics", COMPUTER METHODS AND PROGRAMS IN BIOMEDICINE., ELSEVIER, AMSTERDAM, NL, NL , (19920801), vol. 38, no. 4, doi:10.1016/0169-2607(92)90103-E, ISSN 0169-2607, pages 227 - 239, XP024237123 |
| OPPOSITION | - Reid, A. Vidal, L. Shaw, H. de Bono, J., "Dual inhibition of ErbB1 (EGFR/HER1) and ErbB2 (HER2/neu)", European Journal of Cancer, Elsevier, 34th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, Barcelona, Spain, 34th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, Barcelona, Spain, (20070201), vol. 43, no. 3, doi:10.1016/j.ejca.2006.11.007, ISSN 0959-8049, pages 481 - 489, XP005868776 |
| OPPOSITION | - Heather L. McArthur null, "“Updates in adjuvant systemic treatment of breast cancer", Update on Cancer Therapeutics, (2007), vol. 2, XP022386026 |
| OPPOSITION | - McArthur, H.L. Hudis, C.A., "Updates in adjuvant systemic treatment of breast cancer", UPDATE ON CANCER THERAPEUTICS, ELSEVIER, AMSTERDAM, NL, NL , (20071211), vol. 2, no. 4, doi:10.1016/j.uct.2007.11.001, ISSN 1872-115X, pages 193 - 199, XP022386026 |
| OPPOSITION | - Aron Goldhirsch et al., "2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial", The Lancet, (2013), vol. 382, doi:10.1016/S0140-6736(13)61094-6, XP055414679 |
| OPPOSITION | - Aron Goldhirsch, Richard D Gelber, Martine J Piccart-Gebhart, Evandro De Azambuja, Marion Procter, Thomas M Suter, Christian Jackisch, David Cameron, Harald A Weber, Dominik Heinzmann, Lissandra Dal Lago, Eleanor Mcfadden, Mitch Dowsett, Michael Untch, Luca Gianni, Richard Bell, Claus-Henning Köhne, Anita Vindevoghel, Michael Andersson, A Murray Brunt, Douglas Otero-Reyes, Santai Song, Ian Smith, Brian Leyland-Jones, Jose Baselga, "2 years versus 1 year of adjuvant trastuzumab for HER2-positive breast cancer (HERA): an open-label, randomised controlled trial", The Lancet, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20130921), vol. 382, no. 9897, doi:10.1016/S0140-6736(13)61094-6, ISSN 0140-6736, pages 1021 - 1028, XP055414679 |
| OPPOSITION | - Paul E Goss, Ian E Smith, Joyce O'shaughnessy, Bent Ejlertsen, Manfred Kaufmann, Frances Boyle, Aman U Buzdar, Pierre Fumoleau, William Gradishar, Miguel Martin, Beverly Moy, Martine Piccart-Gebhart, Kathleen I Pritchard, Deborah Lindquist, Yanin Chavarri-Guerra, Gursel Aktan, Erica Rappold, Lisa S Williams, Dianne M Finkelstein, "Adjuvant lapatinib for women with early-stage HER2-positive breast cancer: a randomised, controlled, phase 3 trial", The Lancet Oncology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20130101), vol. 14, no. 1, doi:10.1016/S1470-2045(12)70508-9, pages 88 - 96, XP055414535 |
| OPPOSITION | - Paul E. Goss null, "Adjuvant lapatinib for women with early-stage HER2-positive breast cancer: a randomised, controlled, phase 3 trial", Lancet Oncol, (2013), vol. 14, doi:10.1016/S1470-2045(12)70508-9, XP055414535 |
| OPPOSITION | - Per Eystein Lønning, "Lapatinib in early breast cancer—questions to be resolved", The Lancet Oncology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL, (20130101), vol. 14, no. 1, doi:10.1016/S1470-2045(12)70571-5, ISSN 1470-2045, pages 11 - 12, XP055414537 |
| OPPOSITION | - Arlene Chan et al., "Neratinib after trastuzumab-based adjuvant therapy in patients with HER2positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebocontrolled, phase 3 trial", The Lancet, (2016), vol. 17, doi:10.1016/S1470-2045(15)00551-3, XP029444692 |
| OPPOSITION | - Chan Arlene; Delaloge Suzette; Holmes Frankie A; Moy Beverly; Iwata Hiroji; Harvey Vernon J; Robert Nicholas J; Silovski Tajana; Gokmen Erhan; von Minckwitz Gunter; Ejlertsen Bent; Chia Stephen K L; Mansi Janine; Barrios Carlos H; Gnant Michael; Buyse Marc; Gore Ira; Smith John; Harker Graydon; Masuda Norikazu; Petrakova Katarina; Zotano Angel Guerrero; Iannotti Nicholas; Rodriguez Gladys; Tassone Pierfrancesco; Wong Alvin; Bryce Richard; Ye Yining; Yao Bin; Martin Miguel, "Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial", The Lancet Oncology, ELSEVIER, AMSTERDAM, NL, AMSTERDAM, NL , (20160210), vol. 17, no. 3, doi:10.1016/S1470-2045(15)00551-3, pages 367 - 377, XP029444692 |
| OPPOSITION | - Muss et al., "Adjuvant Chemotherapy in Older Women with Early-Stage Breast Cancer", N. Engl. J. Med, (2009), vol. 360, doi:10.1056/NEJMoa0810266, XP093072165 |
| OPPOSITION | - Muss Hyman B., Berry Donald A., Cirrincione Constance T., Theodoulou Maria, Mauer Ann M., Kornblith Alice B., Partridge Ann H., Dressler Lynn G., Cohen Harvey J., Becker Heather P., Kartcheske Patricia A., Wheeler Judith D., Perez Edith A., Wolff Antonio C., Gralow Julie R., Burstein Harold J., Mahmood Ahmad A., Magrinat Gustav, Parker Barbara A., Hart Ronald D., Grenier Debjani, Norton Larry, Hudis Clifford A., Winer Eric P., "Adjuvant Chemotherapy in Older Women with Early-Stage Breast Cancer", The New England journal of medicine, Massachusetts Medical Society, US, US , (20090514), vol. 360, no. 20, doi:10.1056/NEJMoa0810266, ISSN 0028-4793, pages 2055 - 2065, XP093072165 |
| OPPOSITION | - HJ Burstein et al., "Neratinib (HKI-272), an irreversible pan erbB receptor tyrosine kinase inhibitor: phase 2 results in patients with advanced HER2+ breast cancer.", Cancer Research, (2009), vol. 69, doi:10.1158/0008-5472.SABCS-37, page 37, XP055414664 |
| OPPOSITION | - HJ Burstein; Y Sun; AR Tan; L Dirix; JJ Vermette; C Powell; C Zacharchuk; RA Badwe, "Neratinib (HKI-272), an irreversible pan erbB receptor tyrosine kinase inhibitor: phase 2 results in patients with advanced HER2+ breast cancer.", Cancer research, American Association for Cancer Research, US, US, (20090115), vol. 69, no. Suppl. 2, doi:10.1158/0008-5472.SABCS-37, ISSN 0008-5472, page 37, XP055414664 |
| OPPOSITION | - WONG K-K, ET AL, "A phase I study with neratinib (HKI-272), an irreversible pan ErbB receptor tyrosine kinase inhibitor, in patients with solid tumors.", Clinical Cancer Research, Association for Cancer Research, US, US, (20090401), vol. 15, no. 7, doi:10.1158/1078-0432.CCR-08-1978, ISSN 1078-0432, pages 2552 - 2558, XP002591681 |
| OPPOSITION | - Hudis C A, Barlow W E, Costantino J P, Gray R J, Pritchard K I, Chapman J A, Sparano J A, Hunsberger S, Enos R A, Gelber R D, Zujewski J A, "Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system.", Journal of Clinical Oncology (2020 ASCO-SITC Clinical Immuno-Oncology Symposium), Lippincott Williams & Wilkins, USA, USA , (20070520), vol. 25, no. 15, doi:10.1200/JCO.2006.10.3523, ISSN 1527-7755, pages 2127 - 2132, XP002754386 |
| OPPOSITION | - Eleftherios Mamounas et al., "Benefit From Exemestane As Extended Adjuvant Therapy After 5 Years of Adjuvant Tamoxifen: Intention-to-Treat Analysis of the National Surgical Adjuvant Breast and Bowel Project B-33 Trail ", J. of Clinical Oncology, (2008), vol. 26, doi:10.1200/JCO.2007.14.0228, XP055299834 |
| OPPOSITION | - E. P. Mamounas, J.-H. Jeong, D. L. Wickerham, R. E. Smith, P. A. Ganz, S. R. Land, A. Eisen, L. Fehrenbacher, W. B. Farrar, J. N. Atkins, E. R. Pajon, V. G. Vogel, J. F. Kroener, L. F. Hutchins, A. Robidoux, J. L. Hoehn, J. N. Ingle, C. E. Geyer, J. P. Costantino, N. Wolmark, "Benefit From Exemestane As Extended Adjuvant Therapy After 5 Years of Adjuvant Tamoxifen: Intention-to-Treat Analysis of the National Surgical Adjuvant Breast and Bowel Project B-33 Trial", Journal of Clinical Oncology, American Society of Clinical Oncology, US, US , (20080420), vol. 26, no. 12, doi:10.1200/JCO.2007.14.0228, ISSN 0732-183X, pages 1965 - 1971, XP055299834 |
| OPPOSITION | - Virginia G Kaklamani, William J Gradishar, "Capecitabine treatment options in metastatic breast cancer", Expert Review of Obstetrics and Gynecology, Informa UK, UK, UK , (20090101), vol. 4, no. 4, doi:10.1586/eog.09.15, ISSN 1747-4108, pages 367 - 376, XP055299840 |
| OPPOSITION | - B. Moy, P. E. Goss, "Lapatinib: Current Status and Future Directions in Breast Cancer", THE ONCOLOGIST, (20061101), vol. 11, no. 10, doi:10.1634/theoncologist.11-10-1047, ISSN 1083-7159, pages 1047 - 1057, XP055299836 |
| OPPOSITION | - Paul E. Goss et al., "Lapatinib: Current Status and Future Directions in Breast Cancer", The Oncologist, (2006), vol. 11, doi:10.1634/theoncologist.11-10-1047, XP055299836 |
| OPPOSITION | - William B. Ershle null, "Capecitabine Monotherapy: Safe and Effective treatment for Metastatic Breast Cancer", The Oncologist, (2006), vol. 11, doi:10.1634/theoncologist.11-4-325, XP055299253 |
| OPPOSITION | - William B Ershler, "Capecitabine Monotherapy: Safe and Effective Treatment for Metastatic Breast Cancer", ONCOLOGIST, vol. 11, doi:10.1634/theoncologist.11-4-325, (20060430), pages 325 - 335, ONCOLOGIST, URL: http://theoncologist.alphamedpress.org/content/11/4/325.full.pdf#page=1&view=FitH, (20160901), XP055299253 |
| OPPOSITION | - Jeffrey S. Ross null, "The HER-2 Receptor and Breast Cancer: Ten Years of Targeted Anti-HER Therapy and Personalized Medicine", The Oncologist, (2009), vol. 14, doi:10.1634/theoncologist.2008-0230, XP008119590 |
| OPPOSITION | - Ross Jeffrey S; Slodkowska Elzbieta A; Symmans W Fraser; Pusztai Lajos; Ravdin Peter M; Hortobagyi Gabriel N, "The HER-2 receptor and breast cancer: ten years of targeted anti-HER-2 therapy and personalized medicine.", THE ONCOLOGIST, (20090401), vol. 14, no. 4, doi:10.1634/theoncologist.2008-0230, ISSN 1083-7159, pages 320 - 368, XP008119590 |
| OPPOSITION | - O'shaughnessy Joyce A., Kaufmann Manfred, Siedentopf Friederike, Dalivoust Philippe, Debled Marc, Robert Nicholas J., Harbeck Nadia, "Capecitabine Monotherapy: Review of Studies in First-Line HER-2-Negative Metastatic Breast Cancer", THE ONCOLOGIST, (20120401), vol. 17, no. 4, doi:10.1634/theoncologist.2011-0281, ISSN 1083-7159, pages 476 - 484, XP093138676 |
| OPPOSITION | - Bedard P L; De Azambuja E; Cardoso F, "Beyond trastuzumab: Overcoming resistance to targeted HER-2 therapy in breast cancer", Current cancer drug targets, BENTHAM SCIENCE PUBLISHERS, HILVERSUM, NL, NL , (20090301), vol. 9, no. 2, doi:10.2174/156800909787581024, ISSN 1568-0096, pages 148 - 162, XP009136078 |
| OPPOSITION | - Widakowich C; Dinh P; de Azambuja E; Awada A; Piccart-Gebhart M, "HER-2 positive breast cancer: What else beyond trastuzumab-based therapy?", ANTI-CANCER AGENTS IN MEDICINAL CHEMISTRY, BENTHAM SCIENCE PUBLISHERS LTD., NL, NL , (20080601), vol. 8, no. 5, doi:10.2174/187152008784533062, ISSN 1871-5206, pages 488 - 496, XP008114462 |
| SEARCH | - WISSNER ALLAN ET AL, The development of HKI-272 and related compounds for the treatment of cancer., ARCHIV DER PHARMAZIE AUG 2008 LNKD- PUBMED:18493974, VOL. 341, NR. 8, PAGE(S) 465 - 477, (200808), ISSN 0365-6233, XP002591683 [Y] 1-15 * See abstract and see page 475, passage bridging columns 1-2: HKI-272 is an irreversible HER-2 inhibitor which maintains activity against cancers resistant to reversible inhibitors (gefitinib and erlotinib) * * See page 476, passage bridging columns 1-2: HKI-272 produces 51% response in patients affected by breast cancer after trastumab therapy * |
| SEARCH | - BURSTEIN H ET AL, HKI-272, an irreversible pan erbB receptor tyrosine kinase inhibitor: preliminary phase 2 results in patients with advanced breast cancer., 30TH ANNUAL SAN ANTONIO BREAST CANCER SYMPOSIUM; SAN ANTONIO, TX, USA; DECEMBER 13 -16, 2007, BREAST CANCER RESEARCH AND TREATMENT, VOL. 106, NR. SUPPL. 1, PAGE(S) S268, (200712), ISSN 0167-6806, XP002591682 [Y] 1-15 * See abstract: clinical phase II study involving administration of neratinib (HKI-272), to patients affected by advanced breast cancer previousl administered trastuzumab * |
| SEARCH | - JELLIFFE R W ET AL, "Adaptive control of drug dosage regimens: Basic foundations, relevant issues, and clinical examples", INTERNATIONAL JOURNAL OF BIO-MEDICAL COMPUTING, ELSEVIER SCIENCE PUBLISHERS, SHANNON, IE LNKD- DOI:10.1016/0020-7101(94)90091-4, vol. 36, no. 1-2, ISSN 0020-7101, (19940601), pages 1 - 23, (19940601), XP026260200 [Y] 1-15 * See calculation of optimal dosage regimen in drug therapy * |
| SEARCH | - ILIADIS A ET AL, "APIS: a software for model identification, simulation and dosage regimen calculations in clinical and experimental pharmacokinetics", COMPUTER METHODS AND PROGRAMS IN BIOMEDICINE, ELSEVIER, AMSTERDAM, NL LNKD- DOI:10.1016/0169-2607(92)90103-E, vol. 38, no. 4, ISSN 0169-2607, (19920801), pages 227 - 239, (19920801), XP024237123 [Y] 1-15 * See calculation of optimal dosage regimen in drug therapy * |
| SEARCH | - WONG KWOK-K ET AL, A phase I study with neratinib (HKI-272), an irreversible pan ErbB receptor tyrosine kinase inhibitor, in patients with solid tumors., CLINICAL CANCER RESEARCH : AN OFFICIAL JOURNAL OF THE AMERICAN ASSOCIATION FOR CANCER RESEARCH 1 APR 2009 LNKD- PUBMED:19318484, VOL. 15, NR. 7, PAGE(S) 2552 - 2558, (20090401), ISSN 1078-0432, XP002591681 [Y] 1-15 * See abstract, page 2553, first column and passage bridging pages 2556 and 2557: phase II trials indicates that neratinib has antitumoral activity in patients affected by breast cancer positive to HER-2/neu (ErbB-2), previously treated with trastuzumab * |
| SEARCH | - HUDIS CLIFFORD A ET AL, "Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system.", JOURNAL OF CLINICAL ONCOLOGY : OFFICIAL JOURNAL OF THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY 20 MAY 2007, (20070520), vol. 25, no. 15, ISSN 1527-7755, pages 2127 - 2132, XP002754386 [Y] 1-15 * See definition "disease free survival" * |
| SEARCH | - BEDARD PHILIPPE L ET AL, Beyond trastuzumab: overcoming resistance to targeted HER-2 therapy in breast cancer., CURRENT CANCER DRUG TARGETS MAR 2009 LNKD- PUBMED:19275756, VOL. 9, NR. 2, PAGE(S) 148 - 162, (200903), ISSN 1873-5576, XP009136078 [Y] 1-15 * See abstract and page 148, second column: cancer progress in patients on trastuzumab therapy; Developing strategies to circumvent resistance to trastuzumab is imperative in the treatment of HER-2 positive breast cancer * * See page 151, table 1: strategies to overcome trasduzumab resistance; see in particular the three references to HKI-272 * * See page 154 column 1: "strategies to overcome trastuzumab resistance" and see page 157, passage bridging columns 1-2: HKI-272 produces response in patients affected by refractory HER-2 positive cancer * |
| SEARCH | - WIDAKOWICH C ET AL, "HER-2 positive breast cancer: What else beyond trastuzumab-based therapy?", ANTI-CANCER AGENTS IN MEDICINAL CHEMISTRY, BENTHAM SCIENCE PUBLISHERS LTD, NL LNKD- DOI:10.2174/187152008784533062, (20080601), vol. 8, no. 5, ISSN 1871-5206, pages 488 - 496, XP008114462 [Y] 1-15 * See abstract: second wave of agents to treat tumors overexpressing HER-2 * * See page 488, second column, last two paragraphs: what do use next, after trastuzumab therapy, in case of recurrent or resistant cancers and see page 489: patients developing resistances to trastuzumab * * See table 1 and page 491: neratinib (HKI-292) is part of the second wave of HER-2 kinase inhibitors * |
