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Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer

Title:	Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer
Authors:	Luis Enrique Fein; Diego Lucas Kaen; Ruben Dario Kowalyszyn; Mirta Varela; Guillermo Luis Lerzo; Vanessa Wong; Frances M Boyle; Peter Fox; George Kannourakis; Nicole McCarthy; Nicholas Murray; Meena Okera; Andre van der Westhuizen; Susie Bae; Annabel Goodwin; Michelle Morris; Claire Quaghebeur; Jean-Luc Canon; Luc Dirix; Francois Duhoux; Christel Fontaine; Konstantinos Papadimitriou; Mihaela Mates; Saroj Niraula; Rossanna C Pezo; Martina Puchyr; Joanne Linda Yu; Xinhong Wu; Wenyan Chen; Danmei Pang; Aimin Zang; Jingfen Wang; Ou Jiang; Zhiyong Wu; Florence Dalenc; Laetitia Stefani; Elisabeth Luporsi; Thierry Petit; Anne-Claire Hardy-Bessard; Julien Peron; Lucie Monceau-Baroux; Guillaume Meynard; Jean Christophe Thery; Nadia Harbeck; Joke Tio; Andreas Schneeweiss; Pia Wuelfing; Christian Schem; Hans Tesch; Peter A Fasching; Tjoung-Won Park-Simon; Mattea Reinisch; Pauline Wimberger; Michael Braun; Susanna Hegewisch-Becker; Isabell Witzel; Michael Lux; Marion Van Mackelenbergh; Dorothea Wiebke Fischer; Holger Fischer; Frederik Marmé; Martin Griesshammer; Yousuf B Al-Farhat; Peter Arkosy; Tibor Csoszi; Zsuzsanna Papai; Gabor Laszlo Rubovszky; Zsolt Horvath; Tamar Peretz; Karen Drumea; Shlomit Lubovsky; Amit Itay; Iryna Kuchuk; Rinat Yerushalmi; Samih Yousef; Gleb Kornev; Hadar Goldvaser; Margarita Tokar; Luigi Coltelli; Laura Biganzoli; Filippo Montemurro; Michele Orditura; Ugo De Giorgi; Alberto Zambelli; Elena Rota Caremoli; Federico Piacentini; Marco Angelo Colleoni; Giuseppe Tonini; Nicola Battelli; Pierosandro Tagliaferri; Kenichi Inoue; Fumikata Hara; Hiroji Iwata; Hiroyuki Yasojima; Toshiro Mizuno; Takahiro Nakayama; Mitsuya Itoh; Akihiko Osaki; Tetsuhiko Taira; Kenichi Watanabe; Tatsuya Toyama; Yutaka Yamamoto; Toshinari Yamashita; Yasuhiro Yanagita; Kenjiro Aogi; Shigehira Saji; Masato Takahashi; Seigo Nakamura; Masahiro Takada; Masakazu Toi; Rikiya Nakamura; Yeon Hee Park; Byoung-Yong Shim; Jae Hong Seo; Keon Uk Park; Sung Hoon Sim; Moon Hee Lee; Young Jin Choi; Kyung Hae Jung; Jee Hyun Kim; Seok Yun Kang; Renzo Luzgardo Alvarez Barreda; Henry L Gomez; Zbigniew I Nowecki; Tomasz Kubiatowski; Piotr J Wysocki; Bogdan Zurawski; Mona A Frolova; Anna Tarasova; Lyudmila Zhukova; Petr V Krivorotko; Dmitry Kirtbaya; Rashida Vahidovna Orlova; Alexandra Cortegoso; Angel Guerrero Zotano; Eva Ciruelos Gil; Maria Martinez Garcia; Mafalda Oliveira; Manuel Ramos; Manuel Ruiz-Borrego; Serafin Morales Murillo; Agostina Stradella; Silvia Vazquez Fernandez; Maria Gion Cortes; Josefina Cruz-Jurado; Isabel Calvo Plaza; Pedro Sanchez Rovira; Andres Poveda Velasco; Jose Angel Garcia Saenz; Juan Antonio Virizuela Echaburu; Jose Juan Illarramendi Mañas; Yolanda Jerez Gilarranz; Pilar Zamora Aunon; Blanca Cantos; Mireia Mele Olive; Juan de la Haba; Nuria Ribelles; Yen-Shen Lu; Hwei-Chung Wang; Shin-Cheh Chen; Ling-Ming Tseng; Wei-Pang Chung; Chi-Feng Chung; Kun-Ming Rau; Yin-Hsun Feng; Sacha J Howell; Maria Esther Una Cidon; Amna Sheri; Nicholas C Turner; Sophie McGrath; Daniel John Nelmes; Jeremy Braybrooke; Simon Waters; Trevor A McGoldrick; Sibel H Blau; Stephanie Graff; Mohammad Mozayen; Erika P Hamilton; Lowell L Hart; Chrystal Landry; Ruby Sharma; Priyanka Sharma; Eddie Thara; Omkar S Marathe; William J Irvin; Brooke R Daniel; Vinay Gudena; Yu Cao; Foluso O Ademuyiwa; Paul Coluzzi; Katherine H Rak-Tkaczuk; Jeffrey Neidhart; Paula Klein; Lida Mina; Qing Zhao; Hope S Rugo; Joyce O'Shaughnessy; Konstandinos Sideras; Karthik V Giridhar
Contributors:	Enrique Fein, Lui; Lucas Kaen, Diego; Dario Kowalyszyn, Ruben; Varela, Mirta; Luis Lerzo, Guillermo; Wong, Vanessa; M Boyle, France; Fox, Peter; Kannourakis, George; Mccarthy, Nicole; Murray, Nichola; Okera, Meena; Van Der Westhuizen, Andre; Bae, Susie; Goodwin, Annabel; Morris, Michelle; Quaghebeur, Claire; Canon, Jean-Luc; Dirix, Luc; Duhoux, Francoi; Fontaine, Christel; Papadimitriou, Konstantino; Mates, Mihaela; Niraula, Saroj; C Pezo, Rossanna; Puchyr, Martina; Linda Yu, Joanne; Wu, Xinhong; Chen, Wenyan; Pang, Danmei; Zang, Aimin; Wang, Jingfen; Jiang, Ou; Wu, Zhiyong; Dalenc, Florence; Stefani, Laetitia; Luporsi, Elisabeth; Petit, Thierry; Hardy-Bessard, Anne-Claire; Peron, Julien; Monceau-Baroux, Lucie; Meynard, Guillaume; Christophe Thery, Jean; Harbeck, Nadia; Tio, Joke; Schneeweiss, Andrea; Wuelfing, Pia; Schem, Christian; Tesch, Han; A Fasching, Peter; Park-Simon, Tjoung-Won; Reinisch, Mattea; Wimberger, Pauline; Braun, Michael; Hegewisch-Becker, Susanna; Witzel, Isabell; Lux, Michael; Van Mackelenbergh, Marion; Wiebke Fischer, Dorothea; Fischer, Holger; Marmé, Frederik; Griesshammer, Martin; B Al-Farhat, Yousuf; Arkosy, Peter; Csoszi, Tibor; Papai, Zsuzsanna; Laszlo Rubovszky, Gabor; Horvath, Zsolt; Peretz, Tamar; Drumea, Karen; Lubovsky, Shlomit; Itay, Amit; Kuchuk, Iryna; Yerushalmi, Rinat; Yousef, Samih; Kornev, Gleb; Goldvaser, Hadar; Tokar, Margarita; Coltelli, Luigi; Biganzoli, Laura; Montemurro, Filippo; Orditura, Michele; De Giorgi, Ugo; Zambelli, Alberto; Rota Caremoli, Elena; Piacentini, Federico; Angelo Colleoni, Marco; Tonini, Giuseppe; Battelli, Nicola; Tagliaferri, Pierosandro; Inoue, Kenichi; Hara, Fumikata; Iwata, Hiroji; Yasojima, Hiroyuki; Mizuno, Toshiro; Nakayama, Takahiro; Itoh, Mitsuya; Osaki, Akihiko; Taira, Tetsuhiko; Watanabe, Kenichi
Publication Year:	2023
Collection:	Archivio della ricerca dell'Università di Modena e Reggio Emilia (Unimore: IRIS)
Description:	Background: AKT pathway activation is implicated in endocrine-therapy resistance. Data on the efficacy and safety of the AKT inhibitor capivasertib, as an addition to fulvestrant therapy, in patients with hormone receptor-positive advanced breast cancer are limited. Methods: In a phase 3, randomized, double-blind trial, we enrolled eligible pre-, peri-, and postmenopausal women and men with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer who had had a relapse or disease progression during or after treatment with an aromatase inhibitor, with or without previous cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor therapy. Patients were randomly assigned in a 1:1 ratio to receive capivasertib plus fulvestrant or placebo plus fulvestrant. The dual primary end point was investigator-assessed progression-free survival assessed both in the overall population and among patients with AKT pathway-altered (PIK3CA, AKT1, or PTEN) tumors. Safety was assessed. Results: Overall, 708 patients underwent randomization; 289 patients (40.8%) had AKT pathway alterations, and 489 (69.1%) had received a CDK4/6 inhibitor previously for advanced breast cancer. In the overall population, the median progression-free survival was 7.2 months in the capivasertib-fulvestrant group, as compared with 3.6 months in the placebo-fulvestrant group (hazard ratio for progression or death, 0.60; 95% confidence interval [CI], 0.51 to 0.71; P
Document Type:	article in journal/newspaper
Language:	English
Relation:	info:eu-repo/semantics/altIdentifier/pmid/37256976; info:eu-repo/semantics/altIdentifier/wos/WOS:001078029600009; volume:388; issue:22; firstpage:2058; lastpage:2070; journal:THE NEW ENGLAND JOURNAL OF MEDICINE; https://hdl.handle.net/11380/1312639
DOI:	10.1056/NEJMoa2214131
Availability:	https://hdl.handle.net/11380/1312639; https://doi.org/10.1056/NEJMoa2214131
Accession Number:	edsbas.D6BEE758
Database:	BASE