Breast Cancer Clinical Trial
Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation
The purpose of this two part multicenter, randomized, double-blind, placebo-controlled, Phase III study is to evaluate the efficacy and safety of alpelisib compared to alpelisib matching-placebo in combination with trastuzumab and pertuzumab as maintenance treatment of patients with HER2-positive advanced breast cancer whose tumor harbors a PIK3CA mutation following induction therapy with a taxane in combination with trastuzumab and pertuzumab. Part 1 is the open-label, safety run-in part of the study, designed to confirm the recommended phase 3 dose (RP3D) dose of alpelisib in combination with trastuzumab and pertuzumab. Following Part 1, Part 2 will be initiated, which is the randomized, Phase III part of the study.
Participant has histologically-confirmed HER2-positive breast cancer that is advanced (loco-regionally not amenable to surgery or is metastatic).
Participant has received pre-study induction therapy with up to and including a maximum of 8 cycles of a taxane (docetaxel, paclitaxel, or nab-paclitaxel), plus trastuzumab and pertuzumab. 4 or 5 cycles of induction therapy are permitted if discontinuation of taxane was due to taxane toxicity. Of note, participants enrolled in Part 1 of this study received 4-6 cycles of pre-study induction therapy.
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Participant has adequate bone marrow and organ function
Applies only to Part 2: Participant has a PIK3CA mutation(s) present in tumor prior to enrollment, locally confirmed per test listed in protocol or as determined by a Novartis designated central laboratory.
Participant with inflammatory breast cancer at screening.
Participant with evidence of disease progression during the pre-study induction therapy and prior to first dose of alpelisib (or alpelisib/alpelisib matching-placebo for Part 2)
Participant with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on fasting plasma glucose (FPG) and HbA1c.
Participant has a known history of acute pancreatitis within 1 year of screening or past medical history of chronic pancreatitis
Participant has clinically significant, uncontrolled heart disease and/or recent cardiac events
Participant has a history of Steven-Johnson Syndrome (SJS), erythema multiforme (EM) or Toxic Epidermal Necrolysis (TEN).
Participant has currently documented pneumonitis/interstitial lung disease
Other protocol-defined Inclusion/Exclusion may apply.
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There are 89 Locations for this study
Edegem Antwerpen, 2650, Belgium
Bruxelles , 1200, Belgium
Leuven , 3000, Belgium
Liege , 4000, Belgium
Quebec , G1S 4, Canada
Chang Chun Jilin, 13002, China
Shanghai Shanghai, 20003, China
Hangzhou Zhejiang, 31001, China
Hangzhou Zhejiang, 31002, China
Brno Bohunice Czech Republic, 625 0, Czechia
Hradec Kralove Czech Republic, 500 0, Czechia
Novy Jicin Czech Republic, 74101, Czechia
Zlin Czech Republic, 762 7, Czechia
Praha 10 , 100 3, Czechia
Saint-Cloud Hauts De Seine, 92210, France
Avignon Cedex , 84082, France
Besancon cedex , 25030, France
Caen Cedex , 14021, France
Clermont Ferrand , 63011, France
Creteil , 94000, France
Lyon Cedex , 69373, France
Metz , 57085, France
Montpellier , 34070, France
Pierre Benite Cedex , 69495, France
Saint-Herblain Cédex , 44805, France
Budapest HUN, 1145, Hungary
Budapest , 1062, Hungary
Debrecen , 4032, Hungary
Szekszard , 7100, Hungary
Tatabanya , H 280, Hungary
Jerusalem , 91031, Israel
Jerusalem , 91120, Israel
Ramat Gan , 52621, Israel
Bergamo BG, 24127, Italy
Bologna BO, 40138, Italy
Cona FE, 44100, Italy
Firenze FI, 50134, Italy
Monza MB, 20900, Italy
Macerata MC, 62100, Italy
Milano MI, 20133, Italy
Roma RM, 00128, Italy
Roma RM, 00168, Italy
Mirano VE, 30035, Italy
Napoli , 80131, Italy
Saida , 652, Lebanon
Petaling Jaya Selangor, 46050, Malaysia
Kuala Lumpur , 59100, Malaysia
Amersfoort , 3813 , Netherlands
Dordrecht , 3318A, Netherlands
Maastricht , 6229 , Netherlands
Singapore , 11922, Singapore
Cordoba Andalucia, 14004, Spain
Malaga Andalucia, 29010, Spain
Jerez Cadiz, 11407, Spain
Santander Cantabria, 39008, Spain
Hospitalet de LLobregat Catalunya, 08907, Spain
Valencia Comunidad Valenciana, 46010, Spain
Vigo Pontevedra, 36212, Spain
Barcelona , 08041, Spain
Madrid , 28034, Spain
Madrid , 28040, Spain
Madrid , 28050, Spain
Murcia , 30008, Spain
Bangkok , 10110, Thailand
Bangkok , 10310, Thailand
Ankara , 06520, Turkey
Edirne , 22030, Turkey
Istanbul , 34722, Turkey
Izmir , 35040, Turkey
Samsun , 55200, Turkey
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