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
José Baselga,Seock–Ah –A Im,Hiroji Iwata,Javier Cortes,Michele De Laurentiis,Zefei Jiang,Carlos L. Arteaga,Walter Jonat,Mark Clemons,Yoshinori Ito,Ahmad Awada,Stephen Chia,Agnieszka Jagiełło-Gruszfeld,Barbara Pistilli,Ling Ming Tseng,Sara A. Hurvitz,Norikazu Masuda,Masato Takahashi,Peter Vuylsteke,Soulef Hachemi,Bharani Dharan,Emmanuelle di Tomaso,Patrick Urban,Cristian Massacesi,Mario Campone +24 more
TLDR
This phase 3 study assessed the efficacy of the pan-PI3K inhibitor buparlisib plus fulvestrant in patients with advanced breast cancer, including an evaluation of the PI3K pathway activation status as a biomarker for clinical benefit.Abstract:
Summary Background Phosphatidylinositol 3-kinase (PI3K) pathway activation is a hallmark of endocrine therapy-resistant, hormone receptor-positive breast cancer This phase 3 study assessed the efficacy of the pan-PI3K inhibitor buparlisib plus fulvestrant in patients with advanced breast cancer, including an evaluation of the PI3K pathway activation status as a biomarker for clinical benefit Methods The BELLE-2 trial was a randomised, double-blind, placebo-controlled, multicentre study Postmenopausal women aged 18 years or older with histologically confirmed, hormone receptor-positive and human epidermal growth factor (HER2)-negative inoperable locally advanced or metastatic breast cancer whose disease had progressed on or after aromatase inhibitor treatment and had received up to one previous line of chemotherapy for advanced disease were included Eligible patients were randomly assigned (1:1) using interactive voice response technology (block size of 6) on day 15 of cycle 1 to receive oral buparlisib (100 mg/day) or matching placebo, starting on day 15 of cycle 1, plus intramuscular fulvestrant (500 mg) on days 1 and 15 of cycle 1, and on day 1 of subsequent 28-day cycles Patients were assigned randomisation numbers with a validated interactive response technology; these numbers were linked to different treatment groups which in turn were linked to treatment numbers PI3K status in tumour tissue was determined via central laboratory during a 14-day run-in phase Randomisation was stratified by PI3K pathway activation status (activated vs non-activated vs and unknown) and visceral disease status (present vs absent) Patients, investigators, local radiologists, study team, and anyone involved in the study were masked to the identity of the treatment until unblinding The primary endpoints were progression-free survival by local investigator assessment per Response Evaluation Criteria In Solid Tumors (version 11) in the total population, in patients with known (activated or non-activated) PI3K pathway status, and in PI3K pathway-activated patients Efficacy analyses were done in the intention-to-treat population Safety was analysed in all patients who received at least one dose of study drug and had at least one post-baseline safety assessment according to the treatment they received This trial is registered with ClinicalTrialsgov, number NCT01610284, and is currently ongoing but not recruiting participants Findings Between Sept 7, 2012, and Sept 10, 2014, 1147 patients from 267 centres in 29 countries were randomly assigned to receive buparlisib (n=576) or placebo plus fulvestrant (n=571) In the total patient population (n=1147), median progression-free survival was 6·9 months (95% CI 6·8–7·8) in the buparlisib group versus 5·0 months (4·0–5·2) in the placebo group (hazard ratio [HR] 0·78 [95% CI 0·67–0·89]; one-sided p=0·00021) In patients with known PI3K status (n=851), median progression-free survival was 6·8 months (95% CI 5·0–7·0) in the buparlisib group vs 4·5 months (3·3–5·0) in the placebo group (HR 0·80 [95% CI 0·68–0·94]; one-sided p=0·0033) In PI3K pathway-activated patients (n=372), median progression-free survival was 6·8 months (95% CI 4·9–7·1) in the buparlisib group versus 4·0 months (3·1–5·2) in the placebo group (HR 0·76 [0·60–0·97], one-sided p=0·014) The most common grade 3–4 adverse events in the buparlisib group versus the placebo group were increased alanine aminotransferase (146 [25%] of 573 patients vs six [1%] of 570), increased aspartate aminotransferase (103 [18%] vs 16 [3%]), hyperglycaemia (88 [15%] vs one [ vs none) Serious adverse events were reported in 134 (23%) of 573 patients in the buparlisib group compared with 90 [16%] of 570 patients in the placebo group; the most common serious adverse events (affecting ≥2% of patients) were increased alanine aminotransferase (17 [3%] of 573 vs one [ vs one [ Interpretation The results from this study show that PI3K inhibition combined with endocrine therapy is effective in postmenopausal women with endocrine-resistant, hormone receptor-positive and HER2-negative advanced breast cancer Use of more selective PI3K inhibitors, such as α-specific PI3K inhibitor, is warranted to further improve safety and benefit in this setting No further studies are being pursued because of the toxicity associated with this combination Funding Novartis Pharmaceuticals Corporationread more
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Journal ArticleDOI
PI3K inhibitors: review and new strategies
TL;DR: The search is on for effective specific inhibitors for PI3Kα mutants and the results obtained so far have been limited to drugs that bind to the EMT domain and have shown high specificity towards EMTs.
Journal ArticleDOI
Alterations in PTEN and ESR1 promote clinical resistance to alpelisib plus aromatase inhibitors.
Pedram Razavi,Pedram Razavi,Maura N. Dickler,Payal D. Shah,Weiyi Toy,David N Brown,Helen Won,Bob T. Li,Ronglai Shen,Neil Vasan,Neil Vasan,Shanu Modi,Shanu Modi,Komal Jhaveri,Komal Jhaveri,Betty Ann Caravella,Betty Ann Caravella,Sujata Patil,Sujata Patil,Pier Selenica,Stephen Zamora,Aimee Cowan,Elizabeth A. Comen,Elizabeth A. Comen,Andy Singh,Anne M. Covey,Michael F. Berger,Clifford A. Hudis,Clifford A. Hudis,Clifford A. Hudis,Larry Norton,Larry Norton,Rebecca J. Nagy,Justin I. Odegaard,Richard B. Lanman,David B. Solit,Mark E. Robson,Mark E. Robson,Mario E. Lacouture,Mario E. Lacouture,Edi Brogi,Edi Brogi,Jorge S. Reis-Filho,Mary Ellen Moynahan,Mary Ellen Moynahan,M. Scaltriti,M. Scaltriti,Sarat Chandarlapaty,Sarat Chandarlapaty +48 more
TL;DR: Analysis of tumor and plasma circulating tumor DNA among patients from a phase I/II trial combining alpelisib with an aromatase inhibitor indicates that genomic alterations that mediate resistance to alpel isib or antiestrogen may promote disease progression and highlight PTEN loss as a recurrent mechanism of resistance to PI3Kα inhibition.
Journal ArticleDOI
Genomic profiling of ER+ breast cancers after short-term estrogen suppression reveals alterations associated with endocrine resistance
Jennifer M. Giltnane,Katherine E. Hutchinson,Thomas Stricker,Luigi Formisano,Christian D. Young,Monica V. Estrada,Mellissa J. Nixon,Liping Du,Violeta Sanchez,Paula Gonzalez Ericsson,Maria G. Kuba,Melinda E. Sanders,Xinmeng J. Mu,Eliezer M. Van Allen,Eliezer M. Van Allen,Nikhil Wagle,Nikhil Wagle,Ingrid A. Mayer,Vandana G. Abramson,Henry Gόmez,Monica Rizzo,Weiyi Toy,Sarat Chandarlapaty,Erica L. Mayer,Jason Christiansen,Danielle Murphy,Kerry Fitzgerald,Kai Wang,Jeffrey S. Ross,Jeffrey S. Ross,Vincent A. Miller,Phillip J. Stephens,Roman Yelensky,Levi A. Garraway,Levi A. Garraway,Yu Shyr,Ingrid M. Meszoely,Justin M. Balko,Justin M. Balko,Carlos L. Arteaga,Carlos L. Arteaga +40 more
TL;DR: Genomic profiling of ER+/HER2− breast tumors after short-term estrogen deprivation revealed alterations associated with intrinsic resistance and provided mechanistic insights that suggest druggable alterations that may cause intrinsic endocrine therapy resistance can be identified.
Journal ArticleDOI
Breast Cancer: A Molecularly Heterogenous Disease Needing Subtype-Specific Treatments.
TL;DR: In-depth analyses of the molecular features of primary and metastatic breast cancer have shown the great heterogeneity of genetic alterations and their clonal evolution during disease development, contributing to identify a repertoire of numerous disease-causing genes that are altered through different mutational processes.
Journal ArticleDOI
Inhalation of the prodrug PI3K inhibitor CL27c improves lung function in asthma and fibrosis
Carlo Cosimo Campa,Rangel L. Silva,Rangel L. Silva,Jean Piero Margaria,Tracey Pirali,Matheus Silvério Mattos,Lucas Kraemer,Diego Carlos dos Reis,Giorgio Grosa,Francesca Copperi,Eduardo Monguilhott Dalmarco,Roberto C. P. Lima-Júnior,Roberto C. P. Lima-Júnior,Silvio Aprile,Valentina Sala,Federica Dal Bello,Douglas Silva Prado,José C. Alves-Filho,Claudio Medana,Geovanni Dantas Cassali,Gian Cesare Tron,Mauro M. Teixeira,Elisa Ciraolo,Elisa Ciraolo,Remo Castro Russo,Emilio Hirsch +25 more
TL;DR: Cl27c, a prodrug pan-PI3K inhibitor designed for local therapy, is presented and it is shown that it inhibits lung inflammation and damage in mouse models of asthma and lung fibrosis.
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Detection of Circulating Tumor DNA in Early- and Late-Stage Human Malignancies
Chetan Bettegowda,Chetan Bettegowda,Mark Sausen,Rebecca J. Leary,Isaac Kinde,Yuxuan Wang,Nishant Agrawal,Nishant Agrawal,Bjarne Bartlett,Bjarne Bartlett,Hao Wang,Brandon Luber,Rhoda M. Alani,Emmanuel S. Antonarakis,Nilofer S. Azad,Alberto Bardelli,Henry Brem,John L. Cameron,Clarence Lee,Leslie A. Fecher,Leslie A. Fecher,Gary L. Gallia,Peter Gibbs,Dung T. Le,Dung T. Le,Robert L. Giuntoli,Michael Goggins,Michael D. Hogarty,Matthias Holdhoff,Seung-Mo Hong,Seung-Mo Hong,Yuchen Jiao,Hartmut Juhl,Jenny J. Kim,Giulia Siravegna,Daniel A. Laheru,Calogero Lauricella,Michael Lim,Evan J. Lipson,Suely Kazue Nagahashi Marie,George J. Netto,Kelly S. Oliner,Alessandro Olivi,Louise Olsson,Gregory J. Riggins,Andrea Sartore-Bianchi,Kerstin Schmidt,le-Ming Shih,Sueli Mieko Oba-Shinjo,Salvatore Siena,Dan Theodorescu,Jeanne Tie,Timothy T. Harkins,Silvio Veronese,Tian Li Wang,Jon D. Weingart,Christopher L. Wolfgang,Laura D. Wood,Dongmei Xing,Ralph H. Hruban,Jian Wu,Peter J. Allen,C. Max Schmidt,Michael A. Choti,Victor E. Velculescu,Kenneth W. Kinzler,Bert Vogelstein,Nickolas Papadopoulos,Luis A. Diaz,Luis A. Diaz +69 more
TL;DR: The ability of circulating tumor DNA (ctDNA) to detect tumors in 640 patients with various cancer types was evaluated and suggested that ctDNA is a broadly applicable, sensitive, and specific biomarker that can be used for a variety of clinical and research purposes.
Journal ArticleDOI
Everolimus in Postmenopausal Hormone-Receptor–Positive Advanced Breast Cancer
José Baselga,Mario Campone,Martine Piccart,Howard A. Burris,Hope S. Rugo,Tarek Sahmoud,Shinzaburo Noguchi,Michael Gnant,Kathleen I. Pritchard,Fabienne Lebrun,J. Thaddeus Beck,Yoshinori Ito,Denise A. Yardley,Ines Deleu,Alejandra T. Perez,Thomas Bachelot,L. Vittori,Zhiying Xu,Pabak Mukhopadhyay,David Lebwohl,Gabriel N. Hortobagyi +20 more
TL;DR: Everolimus combined with an aromatase inhibitor improved progression-free survival in patients with hormone-receptor-positive advanced breast cancer previously treated with nonsteroidal aromat enzyme inhibitors.
Journal ArticleDOI
The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study
Richard S. Finn,John Crown,István Láng,Katalin Boér,Igor Bondarenko,Sergey O. Kulyk,Johannes Ettl,Ravindranath Patel,Tamás Pintér,Marcus Schmidt,Yaroslav Shparyk,Anu Thummala,Nataliya L. Voytko,Camilla Fowst,Xin Huang,Sindy T. Kim,Sophia Randolph,Dennis J. Slamon +17 more
TL;DR: Palbociclib (PD-0332991) is an oral, small-molecule inhibitor of cyclin-dependent kinases (CDKs) 4 and 6 with preclinical evidence of growth-inhibitory activity in oestrogen receptor-positive breast cancer cells and synergy with anti-oestrogens as mentioned in this paper.
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José Baselga,Mario Campone,Martine Piccart,Howard A. Burris,Hope S. Rugo,Tarek Sahmoud,Shinzaburo Noguchi,Michael Gnant,Kathleen I. Pritchard,Fabienne Lebrun,J. Thaddeus Beck,Yoshinori Ito,Denise A. Yardley,Ines Deleu,Alejandra T. Perez,Thomas Bachelot,L. Vittori,Zhiying Xu,Pabak Mukhopadhyay,David Lebwohl,Gabriel N. Hortobagyi +20 more
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Ardlie,Rameen Beroukhim,Rameen Beroukhim,Wendy Winckler,Gad Getz,Gad Getz,Stacey Gabriel,Matthew Meyerson,Matthew Meyerson,Lynda Chin,Lynda Chin,Raju Kucherlapati,Katherine A. Hoadley,J. Todd Auman,Cheng Fan,Yidi J. Turman,Yan Shi,Ling Li,Michael D. Topal,Xiaping He,Hann Hsiang Chao,Aleix Prat,Grace O. Silva,Michael D. Iglesia,Wei Zhao,Jerry Usary,Jonathan S. Berg,Michael C. Adams,Jessica K. Booker,Junyuan Wu,Anisha Gulabani,Tom Bodenheimer,Alan P. Hoyle,Janae V. Simons,Matthew G. Soloway,Lisle E. Mose,Stuart R. Jefferys,Saianand Balu,Joel S. Parker,D. Neil Hayes,Charles M. Perou,Simeen Malik,Swapna Mahurkar,Hui Shen,Daniel J. Weisenberger,Timothy J. Triche,Phillip H. Lai,Moiz S. Bootwalla,Dennis T. Maglinte,Benjamin P. Berman,David Van Den Berg,Stephen B. Baylin,Peter W. Laird,Chad J. Creighton,Lawrence A. Donehower,Michael S. Noble,Doug Voet,Nils Gehlenborg,Daniel Di Cara,Juinhua Zhang,Hailei Zhang,Chang-Jiun Wu,Spring Yingchun Liu,Michael S. 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Wong,Artem Sokolov,Janita Thusberg,Sean D. Mooney,Sam Ng,Theodore C. Goldstein,Kyle Ellrott,Mia Grifford,Christopher Wilks,Singer Ma,Brian Craft,Chunhua Yan,Ying Hu,Daoud Meerzaman,Julie M. Gastier-Foster,Julie M. Gastier-Foster,Jay Bowen,Nilsa C. Ramirez,Nilsa C. Ramirez,Aaron D. Black,Robert E. Pyatt,Robert E. Pyatt,Peter White,Peter White,Erik Zmuda,Jessica Frick,Tara M. Lichtenberg,Robin Brookens,Myra M. George,Mark Gerken,Hollie A. Harper,Kristen M. Leraas,Lisa Wise,Teresa R. Tabler,Cynthia McAllister,Thomas Barr,Melissa Hart-Kothari,Katie Tarvin,Charles Saller,George E. Sandusky,Colleen Mitchell,Mary Iacocca,Jennifer Brown,Brenda Rabeno,Christine Czerwinski,Nicholas J. Petrelli,Oleg Dolzhansky,Mikhail Abramov,Olga Voronina,Olga Potapova,Jeffrey R. Marks,Wiktoria Maria Suchorska,Dawid Murawa,Witold Kycler,Matthew Ibbs,Konstanty Korski,Arkadiusz Spychała,Pawel Murawa,Jacek J. Brzeziński,Hanna Perz,Radoslaw Łaźniak,M. Teresiak,Honorata Tatka,Ewa Leporowska,Marta Bogusz-Czerniewicz,Julian Malicki,Andrzej Mackiewicz,Maciej Wiznerowicz,Xuan Van Le,Bernard Kohl,Nguyen Viet Tien,Richard Thorp,Nguyen Van Bang,Howard H. Sussman,Bui Duc Phu,Richard A. Hajek,Nguyen Phi Hung,Huynh Quyet Thang,Khurram Z. Khan,Robert Penny,David Mallery,Erin Curley,Candace Shelton,Peggy Yena,James N. Ingle,Fergus J. Couch,Wilma L. Lingle,Tari A. King,Ana M. Gonzalez-Angulo,Ana M. Gonzalez-Angulo,Mary D. Dyer,Shuying Liu,Xiaolong Meng,Modesto Patangan,Frederic Waldman,Frederic Waldman,Hubert Stoppler,W. Kimryn Rathmell,Leigh B. Thorne,Mei Huang,Lori Boice,Ashley Hill,Carl Morrison,Carmelo Gaudioso,Wiam Bshara,Kelly Daily,Sophie C. Egea,Mark D. Pegram,Carmen Gomez-Fernandez,Rajiv Dhir,Rohit Bhargava,Adam Brufsky,Craig D. Shriver,Jeffrey A. Hooke,Jamie Leigh Campbell,Richard J. Mural,Hai Hu,Stella Somiari,Caroline Larson,Brenda Deyarmin,Leonid Kvecher,Albert J. Kovatich,Matthew J. Ellis,Thomas Stricker,Kevin P. White,Olufunmilayo I. Olopade,Chunqing Luo,Yaqin Chen,Ron Bose,Li-Wei Chang,Andrew H. Beck,Todd Pihl,Mark A. Jensen,Robert Sfeir,Ari B. Kahn,Anna Chu,Prachi Kothiyal,Zhining Wang,Eric E. Snyder,Joan Pontius,Brenda Ayala,Mark Backus,Jessica Walton,Julien Baboud,Dominique L. Berton,Matthew C. Nicholls,Deepak Srinivasan,Rohini Raman,Stanley Girshik,Peter A. Kigonya,Shelley Alonso,Rashmi N. Sanbhadti,Sean P. Barletta,David Pot,Margi Sheth,John A. Demchok,Kenna R. Mills Shaw,Liming Yang,Greg Eley,Martin L. Ferguson,Roy Tarnuzzer,Jiashan Zhang,Laura A.L. Dillon,Kenneth H. Buetow,Peter Fielding,Bradley A. Ozenberger,Mark S. Guyer,Heidi J. Sofia,Jacqueline D. Palchik +355 more