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¦Ñ´¤j¡G ³Ìªñ¹ê¦b¤Ó¦£¡A¯à°Å¶K´N°Å¶K¡A¤Ï¥¿±zµ{«×¦nŪ±o§Ö¡A¤£¥²¤pªº²Ó»¡¡C Copy from¡uOBI-822¡BOBI-833¥H¥~ªº²£«~¡G2015/9/29 ¤U¤È 05:25:24¡v ¡u§C¾¯¶qªºcyclophosphamide¦b°Êª«¹êÅ窺¬ã¨s¦¦b1970s´N³Qµo²{¡C¤HÅ骺³¡¤À¤]ªº½T¥i¦bÀù¯gªvÀø¤¤´î¤Ö¡u§í¨î©ÊT²ÓM¡v§@¥Î¡A¦Ó¤£´î·lCD8+²ÓMªº¹B§@¡A¶¡±µ¼W±jÀù¯g±wªÌ§K¬Ì¤O¡]Bred et al;1987¡^¡]http://www.ncbi.nlm.nih.gov/pubmed/2953413 ¡^¡C «á¨Ó³°ÄòªºÃÒ¾Ú¤]³£¤ä«ù³o¼Ëªº»¡ªk¡A§C¾¯¶qªºcyclophosphamide¥Î¦b«Iŧ©Ê¨ÅÀù¤Î¯ØŦÀù±wªÌ®É¤×¨ä¨ü¨ìÆf¥Ø¡A¦]¬°µo²{³o¨Ç±wªÌªº¶gÃä¦åºÞ©Î¸~½F·LÀô¹Ò¡A§Gº¡¡u½Õ¸`©ÊT²ÓM¡v¡]T reg¡^¡A¥¦·|§í¨î¡uT²ÓM¡v¥\¯à¦Ó¥B·|¥H§í¨î¡u¦ÛµM±þ¤â²ÓM¡v¡]NK cell¡^¼W¥Í»P§@°Ê¡A¾ÉP±þÀù¤O¶q°§C¡F¦Ó§C¾¯¶qªºcyclophosphamide·|°§C¡uCD4+CD25+½Õ¸`©Ê©ÊT²ÓM¡vªº§@¥Î¡A«ì´_¸Ó¦³ªº§K¬Ì¤O¡C¡]http://www.ncbi.nlm.nih.gov/pubmed/?term=ghiringhelli+2007%3Bmetronomic+cyclophos%5Bhamide+regimen+selectively+depletes ¡^¡v ÁÙ¦³³o¤@½g¥i¥H°Ñ¦Ò¡G ¡uMetronomic cyclophosphamide regimen selectively depletes CD4+CD25+ regulatory T cells and restores T and NK effector functions in end stage cancer patients.¡v¡]http://www.ncbi.nlm.nih.gov/pubmed/16960692 ¡^ ºKn¡G¡uCD4+CD25+ regulatory T cells are involved in the prevention of autoimmune diseases and in tumor-induced tolerance. We previously demonstrated in tumor-bearing rodents that one injection of cyclophosphamide could significantly decrease both numbers and suppressive functions of regulatory T cells, facilitating vaccine-induced tumor rejection. In humans, iterative low dosing of cyclophosphamide, referred to as ¡§metronomic¡¨ therapy, has recently been used in patients with advanced chemotherapy resistant cancers with the aim of reducing tumor angiogenesis. Here we show that oral administration of metronomic cyclophosphamide in advanced cancer patients induces a profound and selective reduction of circulating regulatory T cells, associated with a suppression of their inhibitory functions on conventional T cells and NK cells leading to a restoration of peripheral T cell proliferation and innate killing activities. Therefore, metronomic regimen of cyclophosphamide does not only affect tumor angiogenesis but also strongly curtails immunosuppressive regulatory T cells, favoring a better control of tumor progression. Altogether these data support cyclophosphamide regimen as a valuable treatment for reducing tumor-induced immune tolerance before setting to work anticancer immunotherapy.¡v ¦^¨ì822 Low dose Cyclophosphamide¨ì©³¦³¦h§C¡H----822Phase II/III¥Îªº¬O300mg/m2¡C ¼Ð·Ç¾¯¶q¡G450-1000 mg/ m2¡F °ª¾¯¶q¡G>1000 mg/ m2¡C ¥´´X¾¯¡H±z»¡¡u¡K9°w822 + 4°w cyclophosphamide¡Anot every time¡K¡v¡Aªº½Tnot every time¡Abut nearly every time¡I OBI-822¥´¤E¾¯¡G¥Ö¤U¡F²Ä1¡A2¡A3¡A5¡A9¡A13¡A17¡A25¤Î37¶g¡F Cyclophosphamide¥´¤C¾¯¡GÀR¯ß¡F²Ä1¡A5¡A9¡A13¡A17¡A25¤Î37¶g¡C ¦n¤ßªº¯Q¾~¤j¡G §Úı±o¹êÅç²Õ¤Î¹ï·Ó²Õ³£¦³Low dose Cyclophosphamide¡A©Ò¥HÀ³¸Ó¥i¥Hµø¬°Monotherapy¡C¦ý¬O¦pªG¤HÅé¸ÕÅç³£§e²{¥[¤F¤§«á·|¦³¦n¦¨ªG¡A¤S¦ó¥²¥u¥Î822³æ¤è©O¡H ¦óªpLow dose Cyclophosphamideªº°Æ§@¥Î¤ñ°_¨Ó«Ü¤£¿ù¤F¡]http://www.drugs.com/sfx/cytoxan-side-effects.html ¡^ |
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·PÁÂ¥xÁÞ¤jªº»¡©ú¡A"cyclophosphamide ¬O¬°¤F´£°ª§K¬Ì¤O¿Eµo§ÜÅé"³oÓ§Ú¯uªº¨S¦³ª`·N¨ì(¨ä¥Lªº§Ú³£°O±o)¡A²Ä¤@¦L¶H¬Ý¨ì´N·|¥H¬°¬O¤ÆÀøÃÄ¡C ²{¦b·dÀ´¤F¡A¦A¦¸PÁ¡C "Cancer immune escape is frequently associated with the induction of an inappropriate immune response, i.e., a response that does not inhibit but perhaps even promotes the tumor. Indeed, increased frequencies of tumor-infiltrating regulatory T cells (Tregs) are associated with an impaired prognosis in several cancers. Thus, depletion of Tregs, e.g., by cyclophosphamide, was proposed as a means to boost immune responses to cancer." §Ú¦A¬d¤F¤@¤U¡÷ 9°w822 + 4°w cyclophosphamide¡Anot every time(´X¦¸¤£¬O«ÂI¡A¥u¬O¬°¥[±j°O¾Ð¡A©È¤U¦¸¤S§Ñ¤F¡A¤@ª½«ÂаQ½×) °ß±©¤j¡A¦Ñ´¤£¬O¨Ó§ä¹ï¤âªº§r^^¡A¦~·³º¥ªø±o³z¹L°Q½×¥æ¬y¼W±jºû«ù°O¾Ð(§Ú«ÂЪº¤p°ÝÃD¡A¥xÁÞ¤j¤w¸ÑÄÀªº«D±`²M·¡¤F) §Úªº§ë¸êˤ£ºâ»~¥´»~¼²(¨º´N¤Ó©¯¹B¤F)¡A§Ú¬O¨â¦~¦h«e¦b¹Î¶¤·|ij®ÉÅ¥§Ṳ́@¦ìoncologyªº¤p¦Ñ§Ì»¡°_¡A¤@¶}©l¥u¦]¯Î°|ªø³o¦ì¤j¾Çªø ´N¶R¤F¡A¨S¦Ò¼{§Oªº¡I«á¨Ó¤S¤£¤p¤ß¡Agoogle¨ì³oÓª©(³o¨ì¬O¯u©¯¹Bªº¤@¦¸»~¥´»~¼²)¡Aµo²{¦U»â°ìªº°ª¤â³£»ô¶°¤@°ó¡A§ó°í©w¤F«H¤ß¡A ¦p¦¹¦Ó¤w¡A¨S¦³¤°»ò¯S§Oªº¤ß²z¡C ´N¬O¥u¦³°¸º¸¶g¥½¦³ÂIªÅ¡A¥i¥H¦h¬Ý¤@ÂI°T®§¡A@©Ê¤S¤£¤j¦n¡A¤@¬Ý¨ì§K¬Ì¾÷Âà´N·QºÎ(¨º¦ì±i¸g²z¼gªº¤w¸g«D±`²M·¡¡A§ÚÁÙ¬O²ßºD¸õ¹L¥h ·QºÎªº³¡¤À)^^ §Ú¥u¬O¤@ª½±j½Õ¡A¹ï·Ó²Õ116¤HÀ³¸Ó³£PD¤F¡A¤½§GPDªº¤H¼Æ¤¤ÁÙ¦³Global H negativeªº·|¥ýPD¡A±qPhase Iªº27¦ì¬Ý¡AGlobal H positiveªº À³¸Ó¨S¦³¨º»ò¦h¦b¤w¤½§GªºPD¦W³æ¤¤¡A©Ò¥H§¹¥þ¤£¥Î¾á¤ßP value¡A¤§«e¯E§J¤j¤]¼ÒÀÀ¹L¦n¦h¦¸ªºp value¡A§Ú§¹¥þ¬Û«H³o¨Ç¼Æ¾Ú¡I ¦Ü©óPFS¡AOS¡A105wks censored¡Adrop out¡AITT¤§«e¤]³£°Q½×¹L¤F¡C ©Ò¥H§Ú¿ï¾ÜÄ~Äò«ù¦³¡B¥[½Xªº¤è¦V¤@ª½¨SÅÜ¡C Faith¤j¡A§A¯u¬O¤@Óµ½¤ß¤H¡A§Ú³£¤£ÅýÀç·~û¥´¹q¸Üµ¹§Ú¡A¥LÀ³¸Ó³£ÁȤ£¨ì§Úªº¿ú^^ |
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·|û¡G°ß±©10140520 µoªí®É¶¡:2015/12/6 ¤U¤È 08:29:50²Ä 1906 ½g¦^À³
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2015/12/6 ¤U¤È 08:15:01²Ä 1905 ½g¦^À³
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1§Ú»P¦Ñ´¤jªº¨º½g¤À¨ÉºÙ©IÀ³¸Ó¬O ¦Ñ´¤j ¤j¤á¤j ¦U¦ì¤j¤j: ¥u¬O¸ê°T»PÓ¤H¤ß±o¤À¨É 2¤W¤ë12¤éÂd¶RÁ|¿ìªº»¡©ú·|¤½¥q ¹ï¨ÅÀùÃĪ«¦s¬¡ªº¬Ýªk«D±`¥¿½T :¨ÅÀùÃĪ«ªº¦s¬¡n¦b¦³´LÄY¦³«~½è ªº±¡ªp¤U¤~¦³·N¸q 3§Ú»{¬°¯E¹©°µ¨ì¤FUnmet medical need |
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·|û¡G°ß±©10140520 µoªí®É¶¡:2015/12/6 ¤U¤È 07:51:57²Ä 1904 ½g¦^À³
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¯E§J¤j ±z¯à¦b°²¤éÁÙ¥J²Óªº²Îp¸ê®Æ¨Ñ©Ò¦³¤H°Ñ¦Ò¡A ³oÂI¡A¤p§Ì«Ü¨ØªA±z¡A§Ú¤@ª½»{¬°¡A ³oÓ¥@¬É¤W³ÌÃøªº¨Æ¡A´N¬O²³æªº¨Æ¤@ª½«ùÄò°í«ù¡I ¦Ñ´¤j ±z¥i¹J¨ì¹ï¤â°Õ¡I¦Ü¤_±zªº§ë¸ê¡K¡Kºâ»~¥´»~¼²¶Ü¡H¡I ¦³½ìªº¤ß²z¾ÇÆ[ÂI¡I ¤j¤á¤j ¤p§Ì³o¨â¤Ñ¥Î¤O¦apo¤å¡A¨ä¹ê¦³¤@¥b¥Î¤ß¬O§Æ±æÅý±z°Ñ°u¡A ¦]¬°§Úı±o±z¯à±q²³æªº¨Æ¡A¬Ý¨ì¤£Â²³æªº¯à¶q»P°í«ù¡A ªí¥Ü±z¦b±M·~©Î¤H¥ÍÆ[©À¤W¤]¬O°ª¤H¤@µ¥¡I ªp¥B¡A¤p§Ì·Pı¨ì±z¥¿¦bÂàÅÜ¡AÅܱo¡K¡KÅܱo¶V¨Ó¶V·Å·x¡I |
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2015/12/6 ¤U¤È 07:28:19²Ä 1903 ½g¦^À³
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¨ÅÀùOBI 822¦³¥[§C¾¯¶q cyclophosphamide ¨ä°Æ§@¥Î«Ü»´·L §_«h¦¶i³q¤£¹L Data Safety Monitoring Board DSMB ¸ê®Æ¦w¥þºÊ´ú©eû·|ªº9¦¸ªººÊ±± |
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·|û¡G°ß±©10140520 µoªí®É¶¡:2015/12/6 ¤U¤È 07:26:51²Ä 1902 ½g¦^À³
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¤£¾å±oCliff¤j¹ï¦Ñ´»P¥xÁÞ¤jªºpo¤å·N¨£¬O? ®¼·Qťť±zªº¨£¸Ñ¡I Faith¤j ¨þ¨þ¡A±z®¼¦³½ì¡A¬Ý¨Ó¹ï822¨Ó»¡¡A±z¬O¸ò©w¤F¡IÆg¡I ©ñ¤ß¡A¦b3000«e¡A°{«Gªº¬P¬PÀ³¸Ó³£·|¦b¡I |
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·|û¡G«Øcc10140016 µoªí®É¶¡:2015/12/6 ¤U¤È 06:55:28²Ä 1901 ½g¦^À³
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·|û¡G¥xÁÞ10138776 µoªí®É¶¡:2015/12/6 ¤U¤È 06:48:33²Ä 1900 ½g¦^À³
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¦Ñ´¤j 1 ¹ï·Ó²Õ¦³¥[cyclophosphamide 2 ÁC»ÄÆQ½w½Ä¥Í²zÆQ¤ô¡]Phosphate buffered saline¡A²ºÙ¬°PBS¡^¬O¥Íª«¾Ç¬ã¨s¤¤±`¥Îªº½w½Ä²G Phosphate buffered saline ¤£¬OÃÄ 3 ¹êÅç²Õ¥[¤Jcyclophosphamide ¬O¬°¤F´£°ª§K¬Ì¤O¿Eµo§ÜÅé¨ÓÄè·ÀÀù²ÓM»PÀù·F²ÓM ¨C¦¸¥´°w³£n¥[¤J§C¾¯¶q cyclophosphamide 4 ¨ÅÀùOBI822 ¤]¥i¥H»¡¦¨¤£¬OÃĪºÃÄ :¦]¬°¨ä¥´¶i¥hªºªF¦è¤£·|Äè·ÀÀù²ÓM»PÀù·F²ÓM,¬O¥Î¶¡±µ¤è¦¡ ³z¹LÅé²G§K¬Ì»P¥i¯àªº²ÓM§K¬Ì¨ÓÄè·ÀÀù²ÓM»PÀù·F²ÓM (¾É¤Þ§K¬Ì¨t²Î¹v¦V globo-H, SSEA-3 and SSEA-4) 5 ¨ÅÀùOBI822¬O¥þ²y³Ì·s¤@¥NÀù¯g§K¬ÌÀøªk¥Î©ó¨ÅÀùªº²Ä¤@ÁûÃÄ,¯E¹©¬ãµo¹Î¶¤¦³¥ý¨£¤§©ú,§V¤O»P¾Ç³N¬ÉÂåÀø³æ¦ì¦X §@,¤£¤[§Y±N½µP,¦pªG½T©w¦³Àu²§Àø®Ä±N¥ýµo¨î¤H,¥ýÁn¹Ü¤H,°ê»Ú¤j¼t·¥·Q¥ý¸@¬°§Ö 6 ¨ÅÀùOBI822 ¹êÅç²Õ»P¹ï·Ó²Õ¦b¤ñ¸ûªº¬O¨â²Õ¬O§_¦³ÅãµÛ®t²§( PÈ),¤]·|µû¦ô(relative risk, RR)»P¤ÏÀ³²v ¤£¬O¥u¬ÝPFS ,¤]n¬Ý¯f±w³Ì´÷±æªº¥Í¬¡«~½è»Pªø´Á¦s¬¡OS ,¥t¥~¦]¬°¨ÅÀùOBI822¬O¦~»´¥¼¶ùªº¬ü¤k, ¤£¹³¶P¯e§´ (¤wÁp±B ¶PÀù¥ ¼Ú¬wµµm¾J) Ibrance( ¤w¶ùµ¹Letrozole) 7 ±q¥H©¹Áp¦X¥ÎÃĸê°T¨Ó¬Ý¶PÀù¥³æÃÄPFS¬ù¦b6.7Ó¤ë¦Ü7.8Ӥ뤧¶¡( ¤w¯à³Ð³y68»õ¬ü¤¸¦~¾P°âÃB) 8 ¨ÅÀùOBI822 ¾A¥Î¤H¤f¤ñ²v¤j©ó80% , ¨ÅÀùOBI822ªºÄvª§¹ï¤â¤£¬O¥u¦³¥Î©ó°±¸g«áER+ HER- ªºIbrance ,¦Ó¬O¹ï¥þ²y¨ÅÀùÃĪ««Å¾Ô 9 the median overall survival (OS) was 37.5 months with Ibrance compared with 33.3 months with Letrozole alone. (¹êÅç²Õ¤¤¦ì¼ÆÁ`¦s¬¡´Á37.5Ó¤ë ¹ï·Ó²Õ¤¤¦ì¼ÆÁ`¦s¬¡´Á 33.3Ó¤ë) ¥H¤W¬OÓ¤H¬Ýªk»P¤À¨É ¶È¨Ñ°Ñ¦Ò §ë¸êª`·N·ÀIºÞ±± ¦³¿ù½Ð§ó¥¿ http://www.obipharma.com/index.aspx?lang=eng&fn=news_content&no=11 Clinical Study Design The Phase 2/3 randomized controlled trial (RCT) was initiated in December, 2010 with an enrollment target of 342 subjects. The study enrolled female subjects with metastatic breast cancer who achieved stable disease (SD), partial response (PR), or complete response (CR) after at least 1 regimen of anticancer therapy. Subjects were randomized to receive either active treatment (OPT‐822/OPT‐821) plus cyclophosphamide or control (PBS) plus cyclophosphamide in a 2:1 allocation. |
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·|û¡G¦Ñ´10141055 µoªí®É¶¡:2015/12/6 ¤U¤È 05:46:47²Ä 1899 ½g¦^À³
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³o¼Ë¤lªº³]p¬O¦³ÂI©_©Ç³á¡I¦pªG¥X²{°Æ§@¥Î¡A¨º«ç»òª¾¹D¬O822ªº°Æ§@¥Î¡AÁÙ¬Ocyclophosphamideªº°Æ§@¥Î¡AÁöµMlow dose¡I ¤§«e¦n¹³´N¦³¤½§G¤@Ó¡C ¸Ñª¼«á¦³¿ìªkª¾¹D¬O½Ö³y¦¨ªº°Æ§@¥Î§r¶Ü¡H¡I ÀY¦³ÂI·w¤F¡A½Ð¦U¦ì¤j¤j¸Ñ´b(ÁöµM¤£¼vÅTµ²ªG¡AÁÙ¬O«Ü·Qª¾¹DÀY¸£¤ñ¸û²M·¡ªº¤j¤jªº¬Ýªk) ¬Ý¨Ó§Ú¯uªº¥u¾A¦X°Ê¤â¡A¤£¾A¦X°Ê¸£¡I^^ To¦n¤ß¤j¡A§Ú²q¥Lªºlow dose¥i¯à¯uªº«Ü§C¡A§C¨ì¥i¥H¤£¦C¤Jªí®æ¤¤¡AY¬O¦p¦¹¡A·íµM¥i¥Hmonotherapy n§¹³ÓherceptinÀ³¸Ó«Ü²³æ¡A¦ý¬O²×·¥¥Ø¼ÐÁÙ¬OIbrance¡A¦pªG¸Ñª¼PFS¨S¦³¿ìªk¤j©ó20.2Ó¤ë¡A±N¨Ó¶Õ¥²¤]n°µ822+Letrozole¡C Faith¤j¡A¬Ý¨ì±z´N«Ü¦³faith¤F¡C^^ |
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·|û¡GFaith10138335 µoªí®É¶¡:2015/12/6 ¤U¤È 05:46:46²Ä 1898 ½g¦^À³
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¸É¥R¤Úµá¯Sªº§¹¾ã¥y¤l ¥u¦³¤£ª¾¹D¦Û¤v¦b°µ¤°»òªº§ë¸ê¤H¤~»Ýn¤À´²§ë¸ê |
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·|û¡GFaith10138335 µoªí®É¶¡:2015/12/6 ¤U¤È 05:24:58²Ä 1897 ½g¦^À³
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«z¡I³o¨â¤Ñ¤]¤Óºëªö¤F§a¡I ¦Ñ´¤j¡AÅwªï¦^¨Ó¡I °ß°ß¤j ÁöµM¦uÅ@¤ë«Gªº¬P¬P¦³«Ü¦h ¤p§Ì§Æ±æ³Ì°{«Gªº¨º¤@Áû ¯à£¸ª½°{«GµÛ ±i¸³´¿»¡¡G´¤¦³¯E¹©´N¹³¬O´¤¦³¤@®a¤¤¼ú¾÷²v«Ü°ªªº±m¨é¡A¤p§Ì´N§â¥L´¤ºò¤F ¤Úµá¯S»¡¡GY§ë¸ê¹ï¤F¬°¦ón¤À´²§ë¸ê¡H¤p§ÌªºªÑ²¼´N¥u¦³¯E¹© ¨Ã¥B§â¯E¹©«OÀI½cªºÆ_°Í¼È®É¥á¤F¡]¥i¯à·|¥á¦nªø¤@¬q®É¶¡¡^ ¦³¹Ú³Ì¬ü¡A·í¹F¨ì¹Ú·Q®É¡A¦^ÀY¤@¬Ý¡A³o¤@¬q¾úµ{·´º§ó§ó§ó¬ü |
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·|û¡G¦n¤ßªº¯Q¾~10137878 µoªí®É¶¡:2015/12/6 ¤U¤È 05:21:00²Ä 1896 ½g¦^À³
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¦Ñ´¤j,¤£n«È®ð,¤j®a¤Á½R¤Á½R ½Ð°Ý±z,¦pªG¥H¦¹¹êÅç³]p,³Ì«áªºµ²ªG¼Æ¾Ú²z·Qªº¸Ü, obi822¬O¥i¥Hµø¬°¤@ºØmonotherapy for metastatic breast cancer, ÁÙ¬O¤@©wn·f°tcyclophosphamide¤~¯à¨Ï¥Îªº¤@ºØadd-on therapy? |
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·|û¡G¦Ñ´10141055 µoªí®É¶¡:2015/12/6 ¤U¤È 05:19:55²Ä 1895 ½g¦^À³
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§ó¥¿§ó¥¿¡A"Subjects with any of the following MEDICATIONS within 4 weeks prior to randomization:" prior to randomization¡A©Ò¥Hlow dose phosphamide¬O©M822 or PBS¤@°_¥´ªº¡I¥u¬O³oÓ°õµ§ªÌÀ³¸Ón¦b¥Lªºªí®æ¸Ì±¥[¤W¥h¤~¤£·|Åý¤H ¬Ýªº°g½k¡C¦p¡G Experimental arm:OPT-822 (equivalent to 30 £gg of Globo H) in PBS mixed with OPT-821 (100 £gg) PBS Plus low dose cyclophosphamide Placebo arm: Phosphate Buffer Saline (PBS) Plus low dose cyclophosphamide¡I §óÀ³¸Ó´£¨Ñlow dose cyclophosphamide¬O¦hlow dose¤~¹ï¡I µ²½×¬O¡A¿ô¨Ó©M¹Ú¹Ò¬O¤@¼Ëªº¡A¨S¦³¤ñ¸û²¢¬ü¡IµêÅå¤@³õ¤]ªÅÅw³ß¤@³õ¡I«¢«¢¡A±e¤H¦ÛÂZ¡A©êºp©êºp¡C |
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