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
Endocrine therapy combined with targeted therapy in hormone receptor-positive metastatic breast cancer.
Li Bian,Feng-Rui Xu,Zefei Jiang +2 more
TL;DR: This study will systemically review the progress made in endocrine therapy combined with targeted therapy in the treatment of HR-positive MBC and explore biomarkers to guide the more precise use of targeted drugs inendocrine therapy for MBC.
Journal ArticleDOI
Efficacy and safety of everolimus plus exemestane in patients with HR+, HER2- advanced breast cancer progressing on/after prior endocrine therapy in routine clinical practice: Primary results from the non-interventional study, STEPAUT.
Guenther G. Steger,Daniel Egle,Rupert Bartsch,Georg Pfeiler,Edgar Petru,Richard Greil,Ruth Helfgott,Christian Marth,Leopold Öhler,Michael Hubalek,Alois Lang,Christoph Tinchon,Ferdinand Haslbauer,Andreas Redl,Karin Hock,M. Hennebelle,Bernhard Mraz,Michael Gnant +17 more
TL;DR: Real-world safety and efficacy data from STEPAUT were consistent with results from BOLERO-2, supporting everolimus plus exemestane as a suitable treatment option for HR+, HER2− ABC recurring/progressing on/after NSAIs.
Journal ArticleDOI
Targeted Molecular Therapy in Palliative Cancer Management
Staats H,Cassidy C,Kelso J,Mack S,Khalil Choucair,Qaqish H,Willis O,Craig D,Duff J,Laura Stanbery,Edelman G,Dworkin L,John Nemunaitis +12 more
TL;DR: Clinical justification of consideration for precision therapy guided by matched molecular target is provided, specifically focusing on PI3K/mTOR/AKT, BRCA, CDK4/6, EGFR and BRAF V600E for advanced disease cancer patients who previously failed optimal NCCN guideline directed standard of care.
Journal ArticleDOI
Phase Ib Trial of Copanlisib, A Phosphoinositide-3 Kinase (PI3K) Inhibitor, with Trastuzumab in Advanced Pre-Treated HER2-Positive Breast Cancer "PantHER".
Niamh M Keegan,Niamh M Keegan,Simon J Furney,Janice M. Walshe,Giuseppe Gullo,M. John Kennedy,Diarmuid Smith,John McCaffrey,Catherine M Kelly,K. Egan,Jennifer Kerr,Mark F. Given,Peter O'Donovan,Andres Hernando,Ausra Teiserskiene,Imelda Parker,Elaine W. Kay,Angela M. Farrelly,Aoife Carr,Giulio Calzaferri,Ray McDermott,M. Keane,Liam Grogan,Oscar S. Breathnach,Patrick G. Morris,Sinead Toomey,Bryan T. Hennessy +26 more
TL;DR: In this article, the maximum tolerated dose (MTD) of copanlisib, an intravenous (IV) pan-class I PI3K inhibitor, combined with trastuzumab was determined.
Journal ArticleDOI
Management of hormone-receptor positive human epidermal receptor 2 negative advanced or metastatic breast cancers
TL;DR: Hormone therapy, rather than chemotherapy, is recommended for hormone-receptor positive (HR+), human epidermal receptor 2 negative (HER2-) advanced or metastatic breast cancer (A/MBC) according to the European Society of Medical Oncology, ASCO, and National Comprehensive Cancer Network guidelines, unless in visceral crisis in which chemotherapy is indicated.
References
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TL;DR: The ability to integrate information across platforms provided key insights into previously defined gene expression subtypes and demonstrated the existence of four main breast cancer classes when combining data from five platforms, each of which shows significant molecular heterogeneity.
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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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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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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