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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

511

Study ID:

NCT04208178

Recruitment Status:

Recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 89 Locations for this study

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Highlands Oncology Group Main
Fayetteville Arkansas, 72703, United States More Info
Alyssabeth Parsley
Contact
479-872-8130
[email protected]
J. Thaddeus Beck
Principal Investigator
Marin Cancer Care
Greenbrae California, 94904, United States More Info
Melissa Chafoya
Contact
415-925-5000
[email protected]
Kristin Anderson
Principal Investigator
UCLA Medical Center Reg-5
Los Angeles California, 90095, United States More Info
Helene Yang
Contact
+1 301 206 8309
[email protected]
Sara Alsterlind Hurvitz
Principal Investigator
Queen of the Valley Medical Center
Napa California, 94558, United States More Info
Teresa Lund
Contact
707-521-3814
[email protected]
Gurinder Sidhu
Principal Investigator
St Joseph Heritage Healthcare
Santa Rosa California, 94503, United States More Info
Teresa Lund
Contact
707-542-2783
[email protected]
Manasa Vulchi
Principal Investigator
Rocky Mountain Cancer Centers Rocky Mountain Cancer Ctr (50)
Longmont Colorado, 80501, United States More Info
Lorena Alvarez
Contact
714-835-1800
[email protected]
Lori L Jensen
Principal Investigator
Northwestern University Drug Shipment
Chicago Illinois, 60611, United States More Info
Nina Garcia
Contact
312-926-7470
[email protected]
William J. Gradishar
Principal Investigator
Clinical Research Alliance
Lake Success New York, 11042, United States More Info
Arelene Perez
Contact
516-488-2918
[email protected]
Morton Coleman
Principal Investigator
Memorial Sloan Kettering Cancer Center Drug Ship - 2
New York New York, 10065, United States More Info
Betty Mar
Contact
212-639-8186
[email protected]
Sarat Chandarlapaty
Principal Investigator
Univ of Pittsburg Med Ctr Pinnacle
Harrisburg Pennsylvania, 17109, United States More Info
Barbara Heim
Contact
717-652-3000
[email protected]
Kit Lu
Principal Investigator
Texas Oncology McKinney
Allen Texas, 75013, United States More Info
Christy DeCastro
Contact
[email protected]
Monte Jones
Principal Investigator
Texas Oncology, P.A. Austin
Bedford Texas, 76022, United States More Info
Amy Ressel
Contact
512-421-4163
[email protected]
Debra A Patt
Principal Investigator
Presbyterian Hospital of Dallas [email protected]
Dallas Texas, 75231, United States More Info
Nancy Jones
Contact
214-346-3508
[email protected]
Kristi J McIntyre
Principal Investigator
Texas Oncology Flower Mound Texas Oncology, PA
Dallas Texas, 75234, United States More Info
Tiffany Perry
Contact
972-537-4100
[email protected]
Vibha Thomas
Principal Investigator
Texas Oncology Baylor Charles A Sammons Cancer Ctr
Dallas Texas, 75246, United States More Info
Julie Morehouse
Contact
[email protected]
Joyce A O Shaughnessy
Principal Investigator
Texas Oncology P A TX Onc - Med City Dallas
Dallas Texas, 75251, United States More Info
Contact
972-566-4291
Jay Courtright
Principal Investigator
Lumi Research
Kingwood Texas, 77339, United States More Info
Kimberly Pair
Contact
[email protected]
Saleha Sajid
Principal Investigator
Texas Oncology P A
San Antonio Texas, 78217, United States More Info
Rachel Schearer
Contact
[email protected]
Emmalind Aponte
Principal Investigator
University of Wisconsin Regulatory Contact
Madison Wisconsin, 53792, United States More Info
Caitlin Normoyle
Contact
608-262-6873
[email protected]
Mark Burkard
Principal Investigator
Novartis Investigative Site
Edegem Antwerpen, 2650, Belgium
Novartis Investigative Site
Bruxelles , 1200, Belgium
Novartis Investigative Site
Leuven , 3000, Belgium
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Liege , 4000, Belgium
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Quebec , G1S 4, Canada
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Chang Chun Jilin, 13002, China
Novartis Investigative Site
Shanghai Shanghai, 20003, China
Novartis Investigative Site
Hangzhou Zhejiang, 31001, China
Novartis Investigative Site
Hangzhou Zhejiang, 31002, China
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Brno Bohunice Czech Republic, 625 0, Czechia
Novartis Investigative Site
Hradec Kralove Czech Republic, 500 0, Czechia
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Novy Jicin Czech Republic, 74101, Czechia
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Zlin Czech Republic, 762 7, Czechia
Novartis Investigative Site
Praha 10 , 100 3, Czechia
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Saint-Cloud Hauts De Seine, 92210, France
Novartis Investigative Site
Avignon Cedex , 84082, France
Novartis Investigative Site
Besancon cedex , 25030, France
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Caen Cedex , 14021, France
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Clermont Ferrand , 63011, France
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Creteil , 94000, France
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Lyon Cedex , 69373, France
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Metz , 57085, France
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Montpellier , 34070, France
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Pierre Benite Cedex , 69495, France
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Saint-Herblain Cédex , 44805, France
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Budapest HUN, 1145, Hungary
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Budapest , 1062, Hungary
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Debrecen , 4032, Hungary
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Szekszard , 7100, Hungary
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Tatabanya , H 280, Hungary
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Jerusalem , 91031, Israel
Novartis Investigative Site
Jerusalem , 91120, Israel
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Ramat Gan , 52621, Israel
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Bergamo BG, 24127, Italy
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Bologna BO, 40138, Italy
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Cona FE, 44100, Italy
Novartis Investigative Site
Firenze FI, 50134, Italy
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Monza MB, 20900, Italy
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Macerata MC, 62100, Italy
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Milano MI, 20133, Italy
Novartis Investigative Site
Roma RM, 00128, Italy
Novartis Investigative Site
Roma RM, 00168, Italy
Novartis Investigative Site
Mirano VE, 30035, Italy
Novartis Investigative Site
Napoli , 80131, Italy
Novartis Investigative Site
Saida , 652, Lebanon
Novartis Investigative Site
Petaling Jaya Selangor, 46050, Malaysia
Novartis Investigative Site
Kuala Lumpur , 59100, Malaysia
Novartis Investigative Site
Amersfoort , 3813 , Netherlands
Novartis Investigative Site
Dordrecht , 3318A, Netherlands
Novartis Investigative Site
Maastricht , 6229 , Netherlands
Novartis Investigative Site
Singapore , 11922, Singapore
Novartis Investigative Site
Cordoba Andalucia, 14004, Spain
Novartis Investigative Site
Malaga Andalucia, 29010, Spain
Novartis Investigative Site
Jerez Cadiz, 11407, Spain
Novartis Investigative Site
Santander Cantabria, 39008, Spain
Novartis Investigative Site
Hospitalet de LLobregat Catalunya, 08907, Spain
Novartis Investigative Site
Valencia Comunidad Valenciana, 46010, Spain
Novartis Investigative Site
Vigo Pontevedra, 36212, Spain
Novartis Investigative Site
Barcelona , 08041, Spain
Novartis Investigative Site
Madrid , 28034, Spain
Novartis Investigative Site
Madrid , 28040, Spain
Novartis Investigative Site
Madrid , 28050, Spain
Novartis Investigative Site
Murcia , 30008, Spain
Novartis Investigative Site
Bangkok , 10110, Thailand
Novartis Investigative Site
Bangkok , 10310, Thailand
Novartis Investigative Site
Ankara , 06520, Turkey
Novartis Investigative Site
Edirne , 22030, Turkey
Novartis Investigative Site
Istanbul , 34722, Turkey
Novartis Investigative Site
Izmir , 35040, Turkey
Novartis Investigative Site
Samsun , 55200, Turkey

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

511

Study ID:

NCT04208178

Recruitment Status:

Recruiting

Sponsor:


Novartis Pharmaceuticals

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